-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Allotment of ESOP / ESPS
28 Apr 2025, 3:18PM
Intimation regarding allotment of 51495 shares under ESOP.
-
Lupin Ltd. - Press Release
24 Apr 2025, 10:44AM
Lupin Limited has informed the Exchange regarding a press release dated April 24, 2025, titled ""Lupin Receives Approval from U.S. FDA for Tolvaptan T
-
Lupin receives U.S. FDA approval for Tolvaptan Tablets
24 Apr 2025, 11:20AM
Lupin Limited, a leading global pharmaceutical company, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) f
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Press Release / Media Release
24 Apr 2025, 10:46AM
Lupin Receives Approval from U. S. FDA for Tolvaptan Tablets.
-
Lupin Ltd. - Press Release
23 Apr 2025, 10:16AM
Lupin Limited has informed the Exchange regarding a press release dated April 23, 2025, titled ""Lupin Diagnostics Achieves NABL Accreditation for All
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Press Release / Media Release
23 Apr 2025, 10:16AM
Lupin Diagnostics Achieves NABL Accreditation for All Greenfield Labs.
-
Lupin Diagnostics secures NABL accreditation across all greenfield labs
23 Apr 2025, 10:25AM
Lupin Diagnostics Limited (LDL), a wholly owned subsidiary of global pharmaceutical leader Lupin Limited, has achieved full NABL (National Accreditati
-
Lupin Ltd. - Press Release
17 Apr 2025, 2:37PM
Lupin Limited has informed the Exchange regarding a press release dated April 17, 2025, titled ""Lupin Receives EIR from US FDA for its Injectable Fac
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Press Release / Media Release
17 Apr 2025, 2:37PM
Lupin Receives EIR from US FDA for its Injectable Facility in Nagpur.
-
Lupin Ltd. - News Verification
17 Apr 2025, 9:39AM
The Exchange has sought clarification from Lupin Limited with respect to recent news item captioned Lupin, Zydus Life shares fall up to 5% as US court
-
Lupin Ltd. - The Company Has Informed The Exchange About Court Order In The Matter Of A Patent Case.
16 Apr 2025, 9:41PM
The Company has informed the Exchange about court order in the matter of a patent case.
-
Lupin Ltd. - Pendency of Litigation(s)/dispute(s) or the outcome impacting the Company
16 Apr 2025, 9:37PM
Lupin Limited has informed the Exchange about court order in the matter a patent case.
-
Lupin Ltd. - Rumour Verification - Regulation 30(11)
16 Apr 2025, 8:49PM
Lupin Limited has informed the Exchange about Rumour Verification - Regulation 30(11)
-
Lupin Ltd. - Rumour verification - Regulation 30(11)
16 Apr 2025, 6:14PM
Clarification/ confirmation on the news item appearing in www.cnbctv18.com
-
Lupin Ltd. - News Verification
16 Apr 2025, 3:49PM
The Exchange has sought clarification from Lupin Limited with respect to recent news item captioned Lupin, Zydus Life shares fall up to 5% as US court
-
Lupin Ltd. has submitted to BSE the Shareholding Pattern for the Period Ended March 31, 2025
16 Apr 2025, 5:42PM
As of March 2025, 46.92% is owned by Promoters and 53.08% by Public.
<p align=justify>
Among Promoters holding, Indian Promoters holds 46.63% and Fore
-
Lupin Ltd. - Clarification sought from Lupin Ltd
16 Apr 2025, 4:03PM
The Exchange has sought clarification from Lupin Ltd on April 16, 2025, with reference to news appeared in www.cnbctv18.com dated April 16, 2025 quoti
-
Lupin Ltd. - Format of the Initial Disclosure to be made by an entity identified as a Large Corporate : Annexure A
7 Apr 2025, 6:53PM
<b>Format of Initial Disclosure to be made by an entity identified as a Large Corporate.</b><br/><br/> <table border='1px'><tr> <td><b>Sr. No.</b></td
-
Lupin Ltd. - Certificate under SEBI (Depositories and Participants) Regulations, 2018
7 Apr 2025, 11:02AM
Lupin Limited has informed the Exchange about Certificate under SEBI (Depositories and Participants) Regulations, 2018
-
Lupin Ltd. - Compliances-Certificate under Reg. 74 (5) of SEBI (DP) Regulations, 2018
7 Apr 2025, 10:52AM
Certificate under Reg. 74(5) of SEBI (Depositories and Participant) Regulations, 2018 for the quarter ended on March 31, 2025.
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Acquisition
2 Apr 2025, 7:13PM
Lupin Healthcare (UK) Limited, a wholly owned subsidiary of the Company, has acquired the entire share capital of Renascience Pharma Limited, United
-
Lupin Ltd. - Acquisition-XBRL
2 Apr 2025, 7:10PM
Lupin Limited has informed the Exchange regarding Acquisition
-
Lupin Ltd. - Acquisition
2 Apr 2025, 7:07PM
Lupin Limited has informed the Exchange about Lupin Healthcare (UK) Limited, a wholly owned subsidiary of the Company having acquired the entire share
-
Lupin Ltd. - Update-Acquisition/Scheme/Sale/Disposal-XBRL
31 Mar 2025, 7:59PM
Lupin Limited has informed the Exchange regarding Update-Acquisition/Scheme/Sale/Disposal-XBRL
-
Lupin Ltd. - Slump Sale-XBRL
31 Mar 2025, 7:53PM
Lupin Limited has informed the Exchange regarding Slump Sale
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Restructuring
31 Mar 2025, 7:49PM
Modification to the slump sale transaction of transfer of the Over-the-Counter Consumer Healthcare Business.
-
Lupin Ltd. - Other Restructuring
31 Mar 2025, 7:47PM
Lupin Limited has informed the Exchange regarding modification to the slump sale transaction of transfer of the Over-the-Counter Consumer Healthcare B
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Restructuring
31 Mar 2025, 7:44PM
Transfer of Company's API R&D Division to Lupin Manufacturing Solutions Limited, wholly owned subsidiary of the Company on slump sale basis.
-
Lupin Ltd. - Other Restructuring
31 Mar 2025, 7:43PM
Lupin Limited has informed the Exchange regarding transfer of Company s API R&D Division to Lupin Manufacturing Solutions Limited, wholly owned subsid
-
Lupin Ltd. - Board Meeting Outcome for Outcome Of The Board Meeting Held On March 31, 2025.
31 Mar 2025, 7:38PM
Outcome of the Board Meeting held on March 31, 2025.
-
Lupin Ltd. - Outcome of Board Meeting
31 Mar 2025, 7:37PM
Lupin Limited has informed the Exchange regarding Outcome of Board Meeting held on March 31, 2025.
-
Lupin Ltd. - Trading Window-XBRL
28 Mar 2025, 4:41PM
LUPIN LIMITED has informed the Exchange about Closure of Trading Window
-
Lupin Ltd. - Trading Window
28 Mar 2025, 4:40PM
Lupin Limited has informed the Exchange regarding the Trading Window closure pursuant to SEBI (Prohibition of Insider Trading) Regulations, 2015
-
Lupin Ltd. - Change in Directors/ Key Managerial Personnel/ Auditor/ Compliance Officer/ Share Transfer Agent
28 Mar 2025, 4:18PM
LUPIN LIMITED has informed the Exchange about Change in Directors/ Key Managerial Personnel/ Auditor/ Compliance Officer/ Share Transfer Agent
-
Lupin Ltd. - Retirement
28 Mar 2025, 3:56PM
Lupin Limited has informed the Exchange about Retirement of Senior Management Personnel(s).
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Change in Management
28 Mar 2025, 3:54PM
Retirement of Senior Management Personnel(s).
-
Lupin Ltd. - Press Release
22 Mar 2025, 7:54PM
Lupin Limited has informed the Exchange regarding a press release dated March 22, 2025, titled ""Lupin Digital Health Introduces Comprehensive Post-Pr
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Press Release / Media Release
22 Mar 2025, 7:53PM
Lupin Digital Health Introduces Comprehensive Post-Procedure Home-Based Care Guide in Collaboration with the American College of Cardiology.
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Press Release / Media Release
21 Mar 2025, 4:18PM
Nanomi Receives CMO Award for Life Science Leadership in Drug Delivery.
-
Lupin Ltd. - Press Release
21 Mar 2025, 4:15PM
Lupin Limited has informed the Exchange regarding a press release dated March 21, 2025, titled ""Nanomi Receives CMO Award for Life Science Leadership
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Allotment of ESOP / ESPS
21 Mar 2025, 3:23PM
Intimation regarding allotment of 24101 shares under ESOP.
-
Lupin Ltd. - Alteration Of Capital and Fund Raising-XBRL
21 Mar 2025, 3:19PM
LUPIN LIMITED has informed the Exchange regarding Allotment of Securities
-
Lupin Ltd. - ESOP/ESOS/ESPS
21 Mar 2025, 3:17PM
Lupin Limited has informed the Exchange regarding Allotment of 24101 Shares.
-
Lupin Ltd. - Shareholder Meeting / Postal Ballot-Scrutinizer\s Report
20 Mar 2025, 8:57PM
Details of voting results of the business transacted by way of Postal Ballot along with report of the Scrutinizer.
-
Lupin Ltd. - Shareholders meeting
20 Mar 2025, 8:56PM
Lupin Limited has informed the Exchange about details of voting results of the business transacted by way of Postal Ballot along with the report of th
-
Lupin Ltd. - Press Release
20 Mar 2025, 11:51AM
Lupin Limited has informed the Exchange regarding a press release dated March 20, 2025, titled ""Lupin Awarded EcoVadis Silver Medal for Sustainabilit
-
Lupin awarded EcoVadis silver medal for sustainability excellence
20 Mar 2025, 12:09PM
Global pharmaceutical leader Lupin Limited (Lupin) has earned a prestigious Silver Medal from EcoVadis for its exemplary sustainability management acr
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Press Release / Media Release
20 Mar 2025, 11:49AM
Lupin Awarded EcoVadis Silver Medal for Sustainability Excellence, Rank Among the Top 15% Globally.
-
Lupin Ltd. - Update-Acquisition/Scheme/Sale/Disposal-XBRL
18 Mar 2025, 4:39PM
Lupin Limited has informed the Exchange regarding Update-Acquisition/Scheme/Sale/Disposal-XBRL
-
Lupin Ltd. - General Updates
18 Mar 2025, 4:17PM
Lupin Limited has informed the Exchange about incorporation of wholly-owned subsidiary in the name and style LUPINLIFE Consumer Healthcare Limited u
-
Lupin Ltd. - Incorporation Of A Wholly Owned Subsidiary.
18 Mar 2025, 4:14PM
The Company has incorporated a wholly owned subsidiary in the name and style 'LUPINLIFE Consumer Healthcare Limited' under Corporate Identification Nu
-
Lupin Ltd. - Press Release
17 Mar 2025, 10:20AM
Lupin Limited has informed the Exchange regarding a press release dated March 17, 2025, titled ""Lupin Receives Tentative Approval from U.S. FDA for A
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Press Release / Media Release
17 Mar 2025, 10:23AM
Lupin Receives Tentative Approval from U.S. FDA for Amifampridine Tablets.
-
Lupin launches Rivaroxaban Tablets USP, 2.5mg in the United States
7 Mar 2025, 4:42PM
Global pharmaceutical company Lupin Limited has announced the launch of Rivaroxaban Tablets USP, 2.5 mg, in the U.S. market after receiving final appr
-
Lupin Ltd. - Press Release
7 Mar 2025, 4:26PM
Lupin Limited has informed the Exchange regarding a press release dated March 07, 2025, titled ""Lupin Launches Rivaroxaban Tablets USP, 2.5 mg in the
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Press Release / Media Release
7 Mar 2025, 4:26PM
Lupin Launches Rivaroxaban Tablets USP, 2.5mg in the United States.
-
Lupin Ltd. - Alteration Of Capital and Fund Raising-XBRL
27 Feb 2025, 12:18PM
LUPIN LIMITED has informed the Exchange regarding Allotment of Securities
-
Lupin Ltd. - ESOP/ESOS/ESPS
27 Feb 2025, 12:16PM
Lupin Limited has informed the Exchange regarding Allotment of 59940 Shares.
-
Lupin Ltd. - Press Release
27 Feb 2025, 12:04PM
Lupin Limited has informed the Exchange regarding a press release dated February 27, 2025, titled ""Lupin Secures a Place in the Prestigious S&P Globa
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Press Release / Media Release
27 Feb 2025, 12:04PM
Lupin Secures a Place in the Prestigious S&P Global Sustainability Yearbook 2025.
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Allotment of ESOP / ESPS
27 Feb 2025, 12:23PM
Intimation regarding allotment of 59940 shares under ESOP.
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Press Release / Media Release
21 Feb 2025, 4:21PM
Lupin Receives EIR from U. S. FDA for its Somerset Manufacturing Facility.
-
Lupin Ltd. - Press Release
21 Feb 2025, 4:20PM
Lupin Limited has informed the Exchange regarding a press release dated February 21, 2025, titled ""Lupin Receives EIR from U.S. FDA for its Somerset
-
Lupin Ltd. - Analysts/Institutional Investor Meet/Con. Call Updates
19 Feb 2025, 5:30PM
Lupin Limited has informed the Exchange about Transcript of Q3 FY2025 Earnings Conference Call.
-
Lupin Ltd. - Analysts/Institutional Investor Meet/Con. Call Updates
19 Feb 2025, 5:15PM
Lupin Limited has informed the Exchange about Schedule of meet.
-
Lupin Ltd. - Copy of Newspaper Publication
19 Feb 2025, 4:35PM
Lupin Limited has informed the Exchange about Copy of Newspaper Publication w.r.t. dispatch of Postal Ballot Notice.
-
Lupin Ltd. - Press Release
19 Feb 2025, 12:49PM
Lupin Limited has informed the Exchange regarding a press release dated February 19, 2025, titled ""Lupin Receives A- Leadership Rating from CDP in
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Earnings Call Transcript
19 Feb 2025, 5:32PM
Transcript of Q3 FY2025 Earnings Conference Call.
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Analyst / Investor Meet - Intimation
19 Feb 2025, 5:23PM
Intimation about participating in the Analyst/Investors Meet.
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Press Release / Media Release
19 Feb 2025, 12:46PM
Lupin Receives \A-\ Leadership Rating from CDP in Two Categories - Climate Change and Water Security.
-
Lupin Ltd. - Notice Of Shareholders Meetings-XBRL
18 Feb 2025, 2:00PM
Lupin Limited has informed the Exchange about Notice of Shareholders Meeting for Postal Ballot
-
Lupin Ltd. - Shareholders meeting
18 Feb 2025, 1:38PM
Lupin Limited has informed the Exchange regarding the Notice of Postal Ballot.
-
Lupin Ltd. - Shareholder Meeting / Postal Ballot-Notice of Postal Ballot
18 Feb 2025, 1:44PM
Intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 - Postal Ballot Notice.
-
Lupin Ltd. - Copy of Newspaper Publication
13 Feb 2025, 5:29PM
Lupin Limited has informed the Exchange about Copy of Newspaper Publication in respect of Unaudited Financial Results of the Company for the quarter a
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Analyst / Investor Meet - Outcome
12 Feb 2025, 10:07PM
Pursuant to Regulation 30 read with Schedule III Part A Para A(15)(b) of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, the
-
Lupin Ltd. - Analysts/Institutional Investor Meet/Con. Call Updates
12 Feb 2025, 9:57PM
Lupin Limited has informed the Exchange about Link of Audio recording of the Earnings Call Q3 FY25.
-
Lupin Ltd. - Press Release (Revised)
12 Feb 2025, 2:59PM
Lupin Limited has informed regarding a revised press release dated February 12, 2025, titled ""Lupin Q3 FY2025 Results"".
-
Lupin Ltd. - Change in Directors/ Key Managerial Personnel/ Auditor/ Compliance Officer/ Share Transfer Agent
12 Feb 2025, 10:31AM
LUPIN LIMITED has informed the Exchange about Change in Directors/ Key Managerial Personnel/ Auditor/ Compliance Officer/ Share Transfer Agent
-
Lupin Ltd. - Incorporation-XBRL
12 Feb 2025, 8:23AM
Lupin Limited has informed the Exchange regarding Incorporation
-
Lupin Ltd. - Slump Sale-XBRL
12 Feb 2025, 8:20AM
Lupin Limited has informed the Exchange regarding Slump Sale
-
Lupin Ltd. - Investor Presentation
12 Feb 2025, 2:40AM
Lupin Limited has informed the Exchange about Investor Presentation
-
Lupin Ltd. - Press Release
12 Feb 2025, 2:20AM
Lupin Limited has informed the Exchange regarding a press release dated February 12, 2025, titled ""Lupin Q3 FY2025 Results"".
-
Lupin Ltd. - Integrated Filing- Financial
12 Feb 2025, 1:40AM
Integrated Filing (Financial) for quarter ended December 31, 2024.
-
Lupin Ltd. - General Updates
12 Feb 2025, 1:34AM
Lupin Limited has informed the Exchange about formulation, adoption and implementation of Lupin Employees Stock Option Scheme 2025.
-
Lupin Ltd. - Incorporation
12 Feb 2025, 1:28AM
Lupin Limited has informed the Exchange about Incorporation of a wholly owned subsidiary in the name and style LUPINLIFE Consumer Healthcare Limited
-
Lupin Ltd. - Other Restructuring
12 Feb 2025, 1:21AM
Lupin Limited has informed the Exchange about transfer of the Over-the-Counter ( OTC ) Consumer Healthcare Business of the Company, on a slump sale ba
-
Lupin Ltd. - Change in Director(s)
12 Feb 2025, 1:16AM
Lupin Limited has informed the Exchange regarding Change in Director(s) of the company.
-
Lupin Ltd. - Outcome of Board Meeting
12 Feb 2025, 1:11AM
Lupin Limited has informed the Exchange regarding Outcome of Board Meeting held on February 11, 2025.
-
Lupin Ltd. - Financial Result Updates
12 Feb 2025, 12:40AM
Lupin Limited has submitted to the Exchange, the financial results for the period ended December 31, 2024.
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Press Release / Media Release (Revised)
12 Feb 2025, 2:54PM
Lupin Limited has informed regarding a revised Press Release dated February 12, 2025, titled \Lupin Q3 FY2025 Results\.
-
Lupin Q3 net profit up 7.45% at Rs 984.67 cr
12 Feb 2025, 8:50AM
The company reported standalone net profit of Rs 984.67 crore for the quarter ended December 31, 2024 as compared to Rs 916.44 crore in the same perio
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Investor Presentation
12 Feb 2025, 2:43AM
Investor Presentation - Q3 FY25
-
Lupin Ltd. - Integrated Filing (Financial)
12 Feb 2025, 1:42AM
Integrated Filing (Financial) for the quarter ended December 31, 2024.
-
Lupin Ltd. - Formulation, Adoption And Implementation Of Lupin Employees Stock Option Scheme 2025.
12 Feb 2025, 1:31AM
Formulation, adoption and implementation of Lupin Employees Stock Option Scheme 2025 for grant of Employee Stock Options to the Eligible Employees of
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Acquisition
12 Feb 2025, 1:24AM
Incorporation of a wholly-owned subsidiary in the name and style \LUPINLIFE Consumer Healthcare Limited\ or any other appropriate name, as may be appr
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Restructuring
12 Feb 2025, 1:20AM
Transfer of Over-the-Counter Consumer Healthcare Business of the Company, on slump sale basis, to wholly owned subsidiary that is proposed to be incor
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Change in Directorate
12 Feb 2025, 1:13AM
Re-appointment of Ms. Vinita Gupta as Chief Executive Officer and re-appointment of Mr. Ramesh Swaminathan as Whole-Time Director of the Company.
-
Lupin Ltd. - Board Meeting Outcome for Outcome Of Board Meeting - Intimation Under Regulation 30 Of SEBI (Listing Obligations
12 Feb 2025, 1:00AM
Outcome of Board Meeting - Intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015
-
Lupin Ltd. - Unaudited Standalone And Consolidated Financial Results Of The Company For The Quarter And Nine-Months Ended Dec
12 Feb 2025, 12:46AM
Unaudited Standalone and Consolidated Financial Results of the Company for the quarter and nine-months ended December 31, 2024.
-
Lupin Ltd. - Press Release
10 Feb 2025, 4:19PM
Lupin Limited has informed the Exchange regarding a press release dated February 10, 2025, titled ""Lupin Receives Approval from U.S. FDA for Ipratrop
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Press Release / Media Release
10 Feb 2025, 4:19PM
Lupin Receives Approval from U. S. FDA for Ipratropium Bromide Nasal Solution (NASAL Spray), 0.03%
-
Lupin Ltd. - Press Release
10 Feb 2025, 12:31PM
Lupin Limited has informed the Exchange regarding a press release dated February 10, 2025, titled ""Lupin and Natco Receive Approval from U.S. FDA for
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Press Release / Media Release
10 Feb 2025, 12:31PM
Lupin and Natco Receive Approval from U. S. FDA for Bosentan Tablets for Oral Suspension.
-
Lupin Ltd. - Analysts/Institutional Investor Meet/Con. Call Updates
7 Feb 2025, 4:28PM
Lupin Limited has informed the Exchange about participating in the Analyst/Institutional Investors Meet.
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Analyst / Investor Meet - Intimation
7 Feb 2025, 4:26PM
Intimation about participating in the Analyst/Institutional Investors Meet.
-
Lupin Ltd. - Intimation Under Regulation 30 Of SEBI (Listing Obligations And Disclosure Requirements) Regulations, 2015.
6 Feb 2025, 11:56AM
Intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
-
Lupin Ltd. - Action(s) taken or orders passed
6 Feb 2025, 11:56AM
Lupin Limited has informed the Exchange about Action(s) taken or orders passed
-
Lupin Ltd. - Rumour verification - Regulation 30(11)
4 Feb 2025, 6:56PM
Confirmation on the news item appearing in Mainstream Media titled 'Lupin gets USFDA nod for generic HIC drug'.
-
Lupin Ltd. - Rumour Verification - Regulation 30(11)
4 Feb 2025, 6:53PM
Lupin Limited has informed the Exchange about Rumour Verification - Regulation 30(11)
-
Lupin Ltd. - Action(s) taken or orders passed
3 Feb 2025, 5:09PM
Lupin Limited has informed the Exchange about Action(s) taken or orders passed
-
Lupin Ltd. - Intimation Under Regulation 30 Of SEBI (Listing Obligations And Disclosure Requirements) Regulations, 2015.
3 Feb 2025, 5:08PM
Intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Press Release / Media Release
1 Feb 2025, 9:30PM
Lupin Announces Closure of Inspection by U.S. FDA at its Somerset Facility with No Observations.
-
Lupin Ltd. - Press Release
1 Feb 2025, 9:29PM
Lupin Limited has informed the Exchange regarding a press release dated February 01, 2025, titled ""Lupin Announces Closure of Inspection by U.S. FDA
-
Lupin Ltd. - ESOP/ESOS/ESPS
30 Jan 2025, 3:47PM
Lupin Limited has informed the Exchange regarding Allotment of 246462 Shares.
-
Lupin Ltd. - Announcement under Regulation 30 (LODR)-Allotment of ESOP / ESPS
30 Jan 2025, 3:38PM
Intimation regarding allotment of 246462 shares under ESOP.
-
Lupin Diagnostics achieves NABL accreditation for all greenfield labs
24 Apr 2025 , 10:05AM
Lupin rises over 2% to Rs. 2,132.75 in weak market
-
Lupin Diagnostics achieves NABL accreditation for All Greenfield Labs.
23 Apr 2025 , 2:14PM
Accreditation is a testament to the team's dedication to patient care and our mission to promote healthier lives
-
Lupin receives EIR from USFDA for its injectable facility in Nagpur
17 Apr 2025 , 2:59PM
EIR was issued following an inspection of the facility conducted from June
-
Lupin gets tentative USFDA approval for Amifampridinetablets
17 Mar 2025 , 11:50AM
Amifampridine tablets are used to treat lambert-eaton myasthenic syndrome
-
Lupin
10 Mar 2025 , 9:00AM
Launched Rivaroxaban tablets in the US after receiving final approval for its Abbreviated New Drug Application from the USFDA. The drug is used to reduce the risk of major cardiovascular events. Positive
-
Lupin
24 Feb 2025 , 9:02AM
Lupin: The company received Establishment Inspection Report from USFDA for Somerset Manufacturing Unit. Positive
-
Lupin
11 Feb 2025 , 8:55AM
The company has obtained approval from the U.S. FDA for its Abbreviated New Drug Application for Ipratropium Bromide Nasal Solution.
-
Lupin
5 Feb 2025 , 12:20PM
The company has gotten a US FDA tentative approval for its Abbreviated New Drug Application for generic HIC drug. Product will be manufactured at the Company’s Nagpur facility
-
Lupin
3 Feb 2025 , 8:54AM
Lupin announced closure of Pre- approval inspection of Edaravone Oral Suspension, 105 mg/ 5 mL by USFDA at its Somerset Facility with no observations. Positive
-
Lupin
27 Jan 2025 , 12:44PM
The company has received approval from the US health regulator to market a generic HIV medication in the US market. The company has received tentative approval from the US Food and Drug Administration (USFDA) under the US President's Emergency Plan for AIDS Relief (PEPFAR) for Abacavir, Dolutegravir and Lamivudine tablets. The company's product is a generic equivalent of ViiV Healthcare Company's Triumeq PD tablets for oral suspension.
-
Lupin
9 Jan 2025 , 10:09AM
Received the Establishment Inspection Report (EIR) with satisfactory Voluntary Action Indicated (VAI) classification from the United States Food and Drug Administration (US FDA) for its Pithampur Unit-1 manufacturing facility that manufactures both APIs and finished products. Positive
-
Lupin
31 Dec 2024 , 9:51AM
The company announced the acquisition of Huminsulin in India from Eli Lilly and Company to further enhance its diabetes portfolio. Further delay in approval of Anmeal Proair , would drive earnings upgrade for the company-Positive
-
Lupin
19 Dec 2024 , 10:44AM
The pharma company has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Emtricitabine and Tenofovir Alafenamide tablets, 200 mg/25 mg, to market a generic equivalent of Descovy tablets of Gilead Sciences, Inc, in the US markets. Positive
-
Lupin
16 Dec 2024 , 1:05PM
The company announced the acquisition of anti-diabetes trademarks from Boehringer Ingelheim International GmbH to strengthen its diabetes portfolio in the country. As per the agreement, the trademark rights for these brands will be transferred to Lupin by March next year.
-
Lupin launches first generic of Pred Forte in the United States
15 Oct 2024 , 12:15PM
Lupin launches first generic of Pred Forte (Prednisolone Acetate) in the US
-
Lupin
1 Oct 2024 , 12:00PM
Company signs distribution agreement with scope to commercialise Optase range of products in Mexico.
-
Lupin signs distribution agreement with SCOPE to commercialise Optase range of products in Mexico
30 Sep 2024 , 2:17PM
USFDA Inspection of the Company's Manufacturing Facility at Pithampur Unit-1.
-
Lupin enters into patent agreement with Takeda Pharma
18 Sep 2024 , 2:02PM
Lupin enters into patent agreement with Takeda Pharma to commercialise Vonoprazan Tablets in Indian market.
-
Lupin
5 Sep 2024 , 10:44AM
Lupin has introduced Mirabegron extended-release tablets, 50 mg, in the U.S. market. Mirabegron, a drug used to treat overactive bladder, has estimated annual sales of $1.6 billion in the U.S. Positive
-
Lupin
30 Aug 2024 , 11:06AM
Lupin announced the launch of Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials in the United States, after Lupin’s alliance partner, ForDoz Pharma Corporation, USA (ForDoz) received an approval for its ANDA from the United States Food and Drug Administration (U.S. FDA). (Positive)
-
Lupin
16 Aug 2024 , 11:21AM
Lupin has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC), to market a generic equivalent of Lumify® Ophthalmic Solution, 0.025%, of Bausch & Lomb Incorporated. This product will be manufactured at Lupin’s Pithampur facility in India. Brimonidine Tartrate Ophthalmic Solution, 0.025%(OTC) is indicated to relieve redness of the eye due to minor eye irritations. Brimonidine Tartrate Ophthalmic Solution(RLD Lumify®) had an estimated annual sale of USD39million in the U.S. as on IQVIA MAT June2024. (Positive)
-
Stock Update: Lupin
9 Aug 2024 , 12:54PM
Stock Update: Lupin - Strong Q1; complex products to drive growth
-
Lupin
16 Jul 2024 , 10:14AM
Lupin has divested its U.S. Commercial Women’s Health Specialty Business to Evofem Biosciences, Inc. a U.S. biopharmaceutical company focused exclusively on Women’s Health. Lupin’s U.S. Commercial Women’s Health Specialty Business is primarily focused on commercializing SOLOSEC® (secnidazole) 2g oral granules. This FDA-approved single-dose antimicrobial agent provides a complete course of therapy for the treatment of bacterial vaginosis (BV) and trichomoniasis, two common sexual health infections. Under the terms of the deal, Lupin can receive a potential total consideration of up to USD 84 million based on future contingent milestones. (Positive)
-
Lupin
15 Jul 2024 , 9:15AM
Lupin announced that it has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its manufacturing facility in Dabhasa, Gujarat. The said report classified under Voluntary Action Indicated (VAI) status. The facility was inspected from 8 to 12 April 2024. (Positive)
-
Lupin
9 Jul 2024 , 10:18AM
Lupin gets tentative U.S. FDA approval for ANDA of Empagliflozin. Empagliflozin and Metformin Hydrochloride ER Tablets (RLD:Synjardy®XR) had estimated annual sales of USD 357 million in the U.S. (IQVIA MAT November 2020). Positive
-
Lupin
24 Jun 2024 , 10:26AM
Lupin announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its manufacturing facility in Somerset, New Jersey, with a Voluntary Action Indicated (VAI) status. The facility was inspected from May 7 to May 17, 2024. “We are very pleased to have received the EIR with a satisfactory VAI status for our Somerset facility. This is a significant milestone in building our reputation of being best-in-class in Quality and Compliance,” said Nilesh Gupta, Managing Director, Lupin. (Positive)
-
Lupin
22 May 2024 , 12:48PM
The Company and its subsidiaries are involved in legal proceedings, which are often resolved through settlement agreements with the plaintiffs. The Company and its wholly owned subsidiary Lupin Pharmaceuticals, Inc., USA, entered into a settlement agreement with Health Care Service Corporation and Humana Inc. (collectively, the ‘Plaintiffs’) in connection with ongoing litigation for Glumetza, a drug for treatment of diabetes. While the Company denies the Plaintiffs allegations and maintains that it has robust and meritorious defences to the Plaintiffs claims of liabilities and damages, in order to avoid the costs and uncertainties of continued litigation, the Company decided to settle with the Plaintiffs by entering into a Settlement Agreement for an amount of USD nine million. The settlement agreement is neither an admission of facts nor liability by the Company.
-
Lupin
16 May 2024 , 9:48AM
: Lupin Achieves Significant Milestone with ISO 14001 and ISO 45001 Certification. Lupin Achieves Significant Milestone with ISO 14001 and ISO 45001 Certification Across All its Indian Manufacturing Sites, R&D Center and Corporate Office. Global pharma major Lupin Limited (Lupin) today announced that all 12 of its manufacturing sites, its R&D Center and corporate office in India have successfully completed rigorous audits and been certified by DNV for ISO 14001 — Environment Management Systems (EMS), and ISO 45001 — Occupational Health and Safety Management System (OHSMS). This achievement marks a significant milestone in acknowledging Lupin’s commitment to safe and sustainable operations. Positive
-
Stock update: Lupin- Mixed Earnings
8 May 2024 , 11:44AM
Stock update: Lupin- Mixed Earnings: healthy pipeline of complex products to drive growth.
-
Lupin
24 Apr 2024 , 10:47AM
The company announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its Aurangabad manufacturing facility. The inspection was conducted from March 6 to March 15, 2024. The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI). (Positive)
-
Lupin
22 Apr 2024 , 9:04AM
Lupin - Co announced launch of 25 mg strength of generic Mybetriq or mirabegron in the US market. The 25 mg strength has sales of $1b in the US market. (Positive)
-
Stock Update: Lupin
16 Apr 2024 , 10:19AM
Stock Update: Lupin - gSpiriva on a healthy growth track, headwinds receding.
-
Lupin
10 Apr 2024 , 10:11AM
launch first generic version of Oracea® (Doxycycline Capsules, 40 mg), in the United States, after having received an approval from the United States Food and Drug Administration (U.S. FDA). Doxycycline Capsules, 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. Doxycy. Doxycycline Capsules had estimated annual sales of USD 128 million in the U.S. (IQVIA MAT February 2024). Positive
-
Lupin
9 Apr 2024 , 10:07AM
Lupin - received approval from the US health regulator to market a generic medication to treat involuntary movements caused by tardive dyskinesia. The company has received approval from the US Food and Drug Administration (USFDA) to market Valbenazine Capsules in strength of 40 mg and 80 mg. Positive
-
Lupin
18 Mar 2024 , 11:21AM
U.S. FDA inspected Lupin’s manufacturing facility at Aurangabad from March 6 to March 15, 2024. The inspection closed with the issuance of a Form-483 with one (1) observation. We are confident of addressing the concern raised by the U.S. FDA and will resolve the same at the earliest. We uphold quality and compliance with utmost importance and are committed to comply with CGMP quality standards across all our facilities. Positive.
-
Lupin
16 Feb 2024 , 2:38PM
Lupin Receives Approval from U.S. FDA for MinzoyaTM (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets) to market a generic equivalent of Balcoltra®(Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets) 0.1 mg/0.02 mg and 36.5 mg, of Avion Pharmaceuticals LLC. The product will be manufactured at Lupin’s Pithampur facility in India. MinzoyaTM Tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets (RLD Balcoltra®) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT December 2023). (Positive)
-
Lupin gets USFDA nod for Minzoya
16 Feb 2024 , 1:45PM
Minzoya Tablets use to prevent pregnancy
-
Lupin launches Ganirelix Acetate Injection in the United States
15 Feb 2024 , 12:41PM
Ganirelix Acetate is used to inhibit of premature luteinizing hormone surges in women
-
Lupin
14 Feb 2024 , 1:02PM
Lupin Launches Bromfenac Ophthalmic Solution, 0.075% in the United States. Bromfenac Ophthalmic Solution, 0.075% is a generic equivalent of BromSite Ophthalmic Solution, 0.075%, of Sun Pharmaceutical Industries Limited. It is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. Bromfenac Ophthalmic Solution 0.075% had estimated annual sales of USD 15 million in the U.S. (IQVIA MAT December 2023). (Positive)
-
Lupin
8 Feb 2024 , 10:02AM
Lupin reported strong set on numbers with beat in our estimates on all front. The company reported sales growth of 20%, EBITDA growth of 98% and PAT growth of 292% .The company reported strong margins where Gross Margin stands at 66% an EBITDA Margin stands at 19.7%. (Positive)
-
Lupin
7 Feb 2024 , 10:12AM
Lupin Receives Approval from U.S. FDA for Bromfenac Ophthalmic Solution, 0.075%. Lupin is the exclusive first-to-file for this product. This product will be manufactured at Lupin’s Pithampur facility in India. Bromfenac Ophthalmic Solution 0.075% (RLD BromSite®) had estimated annual sales of USD 15 million in the U.S. (IQVIA MAT December 2023). (Positive)
-
Lupin
1 Feb 2024 , 3:37PM
Lupin Receives Approval from U.S. FDA for Dronedarone Tablets, USP. Lupin \announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Dronedarone Tablets USP, 400 mg, to market a generic equivalent of Multaq® Tablets, 400 mg of Sanofi-Aventis U.S. LLC. The product will be manufactured at Lupin’s Goa facility in India. Dronedarone Tablets (RLD Multaq®) had estimated annual sales of USD 510 million in the U.S. (IQVIA MAT December 2023). (Positive)
-
Lupin
25 Jan 2024 , 10:34AM
Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg, to market a generic equivalent of Xarelto® Tablets, of Janssen Pharmaceuticals, Inc. This product will be manufactured at Lupin’s Pithampur facility in India. Rivaroxaban Tablets USP (RLD Xarelto®) had estimated annual sales of USD 8,249 million in the U.S. (IQVIA MAT November 2023). (Positive)
-
Lupin
24 Jan 2024 , 10:26AM
Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg, to market a generic equivalent of Xarelto® Tablets, of Janssen Pharmaceuticals, Inc. This product will be manufactured at Lupin’s Pithampur facility in India. Rivaroxaban Tablets USP (RLD Xarelto®) had estimated annual sales of USD 8,249 million in the U.S. (IQVIA MAT November 2023). (Positive)
-
Lupin
19 Jan 2024 , 10:27AM
Lupin Receives Approval from U.S. FDA for Febuxostat Tablets. Febuxostat Tablets, 40 mg and 80 mg, are indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Febuxostat Tablets (RLD Uloric) had estimated annual sales of USD 27 million in the U.S. (IQVIA MAT November 2023). (Positive)
-
Lupin gets USFDA approval For Febuxostat Tablets
19 Jan 2024 , 10:16AM
Febuxostat Tablets are used for the chronic management of hyperuricemia in adult patients with gout
-
Lupin launches Varenicline Tablets in the United States
10 Jan 2024 , 2:20PM
Varenicline Tablet is indicated for use as an aid to smoking cessation treatment
-
Lupin
10 Jan 2024 , 9:52AM
Lupin Launches Bromfenac Ophthalmic Solution, 0.07% in the United States. Lupin is the exclusive first-to-file for this product and is eligible for 180-day exclusivity. Bromfenac Ophthalmic Solution, 0.07% is the generic equivalent of Prolensa® Ophthalmic Solution, 0.07%, of Bausch & Lomb Inc. It is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac Ophthalmic Solution (RLD Prolensa) had estimated annual sales of USD 182 million in the U.S. (IQVIA MAT November 2023). (Positive)
-
Lupin
5 Jan 2024 , 11:07AM
Lupin announced that it has received tentative approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Dapagliflozin and Saxagliptin Tablets, 5 mg/5 mg and 10 mg/5 mg, to market a generic equivalent of Qtern® Tablets, 5 mg/5 mg and 10 mg/5 mg of AstraZeneca AB. This product will be manufactured at Lupin’s Pithampur facility in India. (Positive)
-
Stock Update: Lupin
29 Dec 2023 , 11:17AM
Stock Update: Lupin - gSpiriva to boost EBITDA margin to 5 years high at 21%
-
Lupin
18 Dec 2023 , 11:21AM
Lupin Receives Approval from U.S. FDA for Allopurinol Tablets USP, 100 mg and 300 mg to market a generic bioequivalent and therapeutically equivalent to the reference listed drug Zyloprim Tablets, 100 mg, and 300 mg, of Casper Pharma, LLC. The product will be manufactured at Lupin’s Pithampur facility in India. Allopurinol Tablets (RLD Zyloprim) had estimated annual sales of USD 88.1 million in the U.S. (IQVIA MAT October 2023). Allopurinol Tablets USP, 100 mg and 300 mg are indicated for the management of adult patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). (Positive)
-
Lupin
15 Dec 2023 , 12:35PM
Lupin Diagnostics Expands Presence in South India with New Regional Reference Laboratory in Chennai. The newly launched laboratory enhances Lupin Diagnostics’ extensive network which now comprises of 36 laboratories and over 600 collection centers across India. Lupin Diagnostics offers an extensive range of reliable and high-quality diagnostic services, including molecular diagnostics, cytogenetics, flow cytometry, cytology, microbiology, serology, haematology, immunology, routine biochemistry, and more, apart from routine and specialized tests. (Neutral)
-
Lupin launches new regional reference laboratory in Chennai
14 Dec 2023 , 3:17PM
Lupin Diagnostics expands presence in South India with New Regional Reference Laboratory in Chennai
-
Lupin gets nod from USFDA for Varenicline Tablets
6 Dec 2023 , 10:21AM
Lupin gets USFDA ANDA nod for Varenicline Tablets which are used as an aid to smoking cessation treatment
-
Lupin
24 Nov 2023 , 10:43AM
Lupin Receives Approval from U.S. FDA for Bromfenac Ophthalmic Solution, 0.07%. Lupin is eligible for 180-day exclusivity period as it is being the first to file. Bromfenac Ophthalmic Solution (RLD Prolensa®) had estimated annual sales of USD 185 million in the U.S. (IQVIA MAT September 2023). The product will be manufactured at Lupin’s Pithampur facility in India. (Positive)
-
Lupin
23 Nov 2023 , 11:59AM
Lupin launched one of the world’s first fixed-dose triple combination drug under the brand name Vilfuro-G® for the effective management of chronic obstructive pulmonary disease in India. This therapeutic innovation by Lupin brings hope to more than 37 million individuals struggling with COPD in India, a condition that ranks among the leading causes of death and disability in the nation. Positive
-
Lupin launches fixed-dose triple combination drug
23 Nov 2023 , 10:55AM
Vilfuro-G for chronic obstructive pulmonary disease (COPD) management in India
-
Lupin receives approval from USFDA for Ganirelix Acetate Injection
17 Nov 2023 , 3:12PM
It is indicated for inhibition of premature luteinizing hormone surge in women
-
Lupin signs licensing & supply agreement with Amman Pharma
10 Nov 2023 , 1:45PM
Lupin, Amman Pharma sign exclusive licensing and supply agreement for Ranibizumab Biosimilar
-
Lupin
8 Nov 2023 , 12:52PM
Lupin Receives Tentative Approval from U.S. FDA for Canagliflozin and Metformin Hydrochloride Extended-Release Tablets 50 mg/500 mg, 50 mg/1,000 mg, 150 mg/500 mg, and 150 mg/1,000 mg to market a generic equivalent of Invokamet XR® Tablets, 50 mg/500 mg, 50 mg/1,000 mg, 150 mg/500 mg, and 150 mg/1,000 mg, of Janssen Pharmaceuticals, Inc. This product will be manufactured at Lupin’s Pithampur facility in India. Canagliflozin and Metformin Hydrochloride Extended-Release Tablets (RLD Invokamet XR®) had estimated annual sales of USD 28 million in the U.S. (IQVIA MAT July 2023). (Positive)
-
Lupin
8 Nov 2023 , 12:36PM
Lupin Launches Rocuronium Bromide Injection in the United States. Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Multiple-Dose Vials is the generic version of Zemuron® Injection, 50 mg/5 mL and 100 mg/10 mL of Organon USA Inc. and is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Rocuronium Bromide Injection (RLD: Zemuron®) had estimated annual sales of USD 54 million in the U.S. (IQVIA MAT August 2023). Positive read through
-
Lupin gets USFDA tentative nod for ANDA for Selexipag for injection
2 Nov 2023 , 1:40PM
Selexipag for injection is used treat pulmonary arterial hypertension
-
Lupin
1 Nov 2023 , 9:39AM
Lupin received Establishment Inspection Report from U.S. FDA for the Company’s Mandideep Unit-2 manufacturing facility. The EIR was issued post the last inspection of the facility conducted from August 7 to August 11, 2023. The inspection closed with the facility receiving an inspection classification of "No Action Indicated" (NAI). (Positive)
-
Lupin
25 Oct 2023 , 10:41AM
Lupin Receives Approval for its Abbreviated New Drug Application for Fluconazole Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg, to market a generic equivalent of Diflucan® Tablets, 50 mg, 100 mg, 150 mg, and 200 mg, of Pfizer, Inc. This product will be manufactured at Lupin’s Pithampur facility in India. Fluconazole Tablets USP (RLD Diflucan) had estimated annual sales of USD 43 million in the U.S. (IQVIA MAT July 2023).
-
Lupin
17 Oct 2023 , 11:55AM
Lupin Limited have planned to enter into a Business Transfer Agreement (‘BTA’) with Lupin Manufacturing Solutions Limited (‘LMSL’), wholly owned subsidiary of the Company, to carve out two Active Pharmaceutical Ingredients manufacturing sites situate at Dabhasa and Visakhapatnam and select R&D operations, including fermentation, at Lupin Research Park, Pune
-
Lupin
16 Oct 2023 , 11:59AM
Lupin announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Apalutamide Tablets, 60 mg, to market a generic equivalent of Erleada® Tablets, 60 mg of Janssen Biotech, Inc. Apalutamide Tablets, 60 mg, (RLD Erleada®) had estimated annual sales of USD 1,185.5 million in the U.S.(IQVIA MAT July 2023). (Positive)
-
Lupin
13 Oct 2023 , 11:29AM
Lupin Receives Tentative Approval from U.S. FDA for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution. The net product sales for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution (RLD Xywav) were USD 958.4 million for the year ending December 2022 and USD 604.3 million for the first six months of 2023. (Positive).
-
Lupin
6 Oct 2023 , 11:21AM
Lupin receives tentative approval from U.S. FDA for Tolvaptan tablets. Tolvaptan tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023). Lupin received approval for Tolvaptan Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg to market a generic equivalent of Jynarque Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Co., Ltd. This product will be manufactured at Lupin’s Nagpur facility in India. View – Lupin is getting approval for big complex products, hence it is positive for the company.
-
Lupin gets EIR from USFDA for Nagpur Unit-Manufacturing Facility
29 Sep 2023 , 3:35PM
USFDA classifies co's Nagpur Unit-1 As Voluntary Action Indicated
-
Lupin
29 Sep 2023 , 3:14PM
Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 Manufacturing Facility. The EIR was issued post the last inspection of the facility conducted in July 2023. The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI), (Positive).
-
Lupin
22 Sep 2023 , 2:40PM
Lupin acquired 5 brands from Menarini for a consideration of Rs 1bn. Menarini is an Italian pharma group and the 5 brands acquired are Piclin (Picosulphate Sodium), Menoctyl (Otilonium Bromide), Sucramal O (Sucralfate + Oxetacaine), Pyridium (Phenazopyridine) and Distaclor (Cefaclor) are being acquired. Lupin has been exclusively marketing these brands in the Indian market since July 2021 under a distribution and promotion agreement with Menarini India Private Limited. The sales of these brands as on FY23 stood at Rs 32.2 crs. This news is neutral as lupin was already selling these drugs in the Indian market from 2021.
-
Lupin acquires Five Brands from Menarini
22 Sep 2023 , 1:36PM
Lupin signs agreement with Italy-based Menarini Group to acquire five brands for Rs. 101 crore
-
Lupin
7 Sep 2023 , 10:18AM
The company has joined hands with Mark Cuban's Cost Plus Drugs and the COPD Foundation to the improve availability and affordability of drugs to treat Chronic Obstructive Pulmonary Disease (COPD) in the US. COPD is a life-threatening condition that affects over 15 million adults in the United States and ranks as the fourth leading cause of death in the country – Positive read through for the stock.
-
Lupin acquires Ondero & Ondero - Met brands from Boehringer Ingelheim
18 Aug 2023 , 3:25PM
Lupin buys brand ONDERO and ONDERO MET to expand Diabetes Portfolio in India
-
Lupin
17 Aug 2023 , 10:38AM
The company has announced the launch of Tiotropium Bromide Inhalation Powder, 18 mcg/capsule, for the treatment of chronic obstructive pulmonary disease (COPD) in the US. Tiotropium Bromide Inhalation Powder, 18 mcg/capsule is a generic equivalent of Spiriva® HandiHaler® (Tiotropium Bromide Inhalation Powder), 18 mcg/capsule of Boehringer Ingelheim Pharmaceuticals, Inc. Positive for the stock.
-
Lupin
9 Aug 2023 , 10:12AM
The company arm receives USFDA Anda approval for Fluocinlone Acetonide Body Oil which used to treat Eczema, a skin condition – Positive read through for the stock
-
Lupin
2 Aug 2023 , 11:36AM
The company announced that its subsidiary, Novel Laboratories Inc. based in Somerset, NJ has received approval from the USFDA for its ANDA for Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil), a generic equivalent of Derma-Smoothe/FS Topical Oil, 0.01% (Scalp Oil), of Hill Dermaceuticals, Inc. This product will be manufactured at Lupin’s Somerset facility in the US. Fluocinolone Acetonide Topical Oil (RLD Derma-Smoothe/FS) had estimated annual sales of USD 9 million in the U.S. (IQVIA MAT Mar 2023). Positive for the stock.
-
Lupin
2 Aug 2023 , 10:39AM
Lupin announced that it has received approval from the USFDA for its ANDA for gTurqoz (Norgestrel and Ethinyl Estradiol Tablets USP), a birth control pill of Wyeth Pharmaceuticals LLC, which will be manufactured at Lupin’s Pithampur facility in India. The drug has annual sales of USD 34 million as per IQVIA MAT Mar 2023. Positive for the stock. At the same time, Lupin Pharmaceuticals, the US arm of Lupin Ltd. has issued a voluntary recall of two lots of birth control pills, Tydemy tablets, due to its potential that they were not effective in preventing pregnancy. The company is pulling two lots of Tydemy tablets due to out-of-specification test results at the 12-month stability time point. No adverse effects related to the recall have been reported to date, the company said. Negative read through for the stock.
-
Lupin
28 Jul 2023 , 11:30AM
Lupin informed that it has resolved warning letter for its facilities in Goa and Pithampur Unit 2, Indore as intimated by the USFDA. The warning letter was issued in 2017. It’s a strong positive.
-
Lupin
27 Jul 2023 , 3:22PM
Lupin Ltd. has formed Lupin Manufacturing Solutions Ltd. as a wholly owned subsidiary for undertaking contract development and manufacturing activities. Positive read through.
-
Lupin
26 Jul 2023 , 3:41PM
Lupin Ltd.: The company has announced receipt of approval for Tiotropium 18 micrograms powder for inhalation in capsules for use with LupinHaler, its bioequivalent version of Spiriva from Therapeutic Goods Administration (TGA) of Australia. Tiotropium Bromide Inhalation Powder (Reference Product Spiriva®) had estimated annual sales of USD 10 million in Australia (IQVIA MAT Mar 2023. Positive for the stock.
-
Lupin
24 Jul 2023 , 1:01PM
Lupin Digital Health, the cardiology digital therapeutics (DTx) platform and the American College of Cardiology (ACC) announced a first of its kind collaboration to deliver in home cardiovascular care with Digital therapeutics in India. This collaboration aims to accelerate the application and adoption of DTx platform, Lyfe and also aims to accelerate the application and adoption of DTx in Cardiology in India. Positive.
-
Lupin collaborates with American College of Cardiology
24 Jul 2023 , 12:56PM
Lupin collaborates with American College of Cardiology to deliver in-home cardiovascular care to accelerate application & adoption of DTX in cardiology in India
-
Lupin
24 Jul 2023 , 12:19PM
Lupin Ltd. announced receipt of tentative approval from the USFDA under the US President’s Emergency Plan for AIDS relief for the company’s New Drug Application (NDA) for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets. Positive for the stock.
-
Lupin incorporates unit Lupin Atharv ability for neuro-rehabilitation business
21 Jul 2023 , 12:59PM
Lupin incorporates Lupin Atharv Ability Ltd., wholly owned subsidiary for neuro rehabilitation business
-
Lupin
21 Jul 2023 , 12:54PM
The company has incorporated Lupin Atharv Ability Ltd., wholly owned subsidiary for neuro rehabilitation business. The multi-disciplined robotic and computer-assisted centre is possibly the only one of its kind in India with a range of rehabilitation programs for post-stroke patients, patients with traumatic brain injury, spinal cord injury, paediatric neurological conditions, Parkinson’s, cerebral palsy, and multiple sclerosis. Each centre would have about 20-odd people including therapists, and services would be tailored to the need of the individual, with prices averaging at about Rs 1,500 for a 45-minute therapy. The company has one centre in Mumbai and plans to add 2 more in 2023. Positive read through.
-
Lupin
13 Jul 2023 , 11:40AM
Lupin Ltd. has received form 483 with 2 observations for its Nagpur oral solid dosage facility from the USFDA. Negative read through for the stock.
-
Lupin
12 Jul 2023 , 12:20PM
Lupin Ltd. has received EIR from the USFDA for its Pithampur Unit – 2 manufacturing facility that manufactures oral solids and ophthalmic dosage forms. The USFDA classifies the inspection as Voluntary Action Indicated (VAI). It will help the company to gain new approvals and launches especially for ophthalmic products. Positive read through for the stock
-
Lupin gets EIR from USFDA for its Pithampur Unit-2 Manufacturing facility
12 Jul 2023 , 10:56AM
Lupin gets EIR from USFDA for its Pithampur Unit-2 Manufacturing facility
-
Lupin
6 Jul 2023 , 2:39PM
Lupin Ltd. informed that its allotment committee of Directors at its meeting held today on July 06, 2003, allotted 16,139 fully paid-up equity shares of Rs. 2 each. These shares have been allotted upon exercising of options granted to the employees under stock options plans of the company. As such the issued and paid-up capital of the company has been increased to Rs. 91 Cr. consisting of 45.51 cr. equity shares of Rs. 2 each. Vs. 45.30 cr equity shares it was in Q4FY23. Neutral read through.
-
Lupin
5 Jul 2023 , 10:42AM
Lupin Ltd. announced that it has received tentative approval for its ANDA, Dolutegravir tablets (RLD Tivicay PD tablets) for oral suspension of ViiV Healthcare. It has annual sales of USD 1 million in the US as per IQVIA MAT Mar 23. Positive for the stock.
-
Lupin
4 Jul 2023 , 10:42AM
Lupin announced that it has received approval from the USFDA for its ANDA for Cyanocobalamin Nasal Spray 500 mcg, / spray a generic equivalent of Nascobal Nasal spray of Par Pharma Inc. It will be manufactured at Lupin’s Somerset facility in the US. The drug has annual sales of USD 69 million in the US (IQVIA MAT Mar 23).
-
Lupin
30 Jun 2023 , 10:25AM
Lupin announced achievement of a key milestone for its novel product MALT1 inhibitor that is partnered with AbbVie inc. towards treatment of haematological cancers. As part of the agreement, Lupin has received USD 25 million from AbbVie for initiation of Phase 1 clinical studies successfully. Lupin had earlier received USD 30 million from AbbVie for achievement of other milestones in the program. Positive for the stock.
-
Lupin
27 Jun 2023 , 10:53AM
Lupin is mulling stake sale in its API business as per market reports. If it fructifies it will be beneficial to its plan to expand margins further. API business contributes 7% of sales and has recovered in FY23 with a 12% rise in sales vs. decline of 28% seen in FY22. Attractive valuations, bright prospects and certified plants make the Indian API sector attractive for Indian and global investors. Apart from the market and the structural factors, a government push for the sector has further lifted the prospects for API players. Sentimentally positive for the stock.
-
Stock Update: Lupin
26 Jun 2023 , 11:07AM
Stock Update: Lupin Ltd. (Company Update): gSpiriva a boost, yet stay on guard
-
Lupin launches Rufinamide oral suspension in the US
23 Jun 2023 , 12:21PM
Rufinamide is used to control seizures in epilepsy patients
-
Lupin
23 Jun 2023 , 12:14PM
Lupin Ltd. announced the launch of Rufinamide oral suspension 40 mg/mL to market generic of Banzel Rufinamide, which had estimated annual sales of USD 72 million in the U.S. (IQVIA MAT April 2023).
-
Lupin
21 Jun 2023 , 1:30PM
Lupin announced that the USFDA has approved ANDA for Tiotropium Bromide Inhalation powder, a generic of Spiriva hand inhaler of Boehringer Ingelheim Pharmaceuticals, Inc. This product will be manufactured at Lupin’s Pithampur facility in India. This is the first generic approval for Spiriva HandiHaler in the U.S., and is also the first DPI approval from India for the U.S. This is an important milestone in its journey of building its respiratory franchise globally. Tiotropium Bromide Inhalation Powder (RLD Spiriva®) had estimated annual sales of USD 1,264 million in the U.S. (IQVIA MAT Mar 2023).
-
Lupin gets nod from USFDA for Tiotropium Dry Powder Inhaler.
21 Jun 2023 , 1:28PM
Lupin becomes first Generic Player to get USFDA approval for gSpiriva
-
Lupin
19 Jun 2023 , 2:47PM
Lupin Ltd. has received EIR from the USFDA for its API manufacturing facility located at Vishakhapatnam, India and received No Action Indicated (NAI) status for the same. Positive read through for the stock.
-
Lupin
19 Jun 2023 , 11:07AM
Lupin Ltd. announced launch of Thiamine Hydrochloride Injection USP, 200 mg/2 mL (100 mg/mL) Multiple-dose Vials, after Lupin’s alliance partner Caplin Steriles Limited (Caplin) received an approval for its ANDA from the United States Food and Drug Administration (U.S. FDA). Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S. (IQVIA MAT April 2023). Positive read through for both Lupin and Caplin Point as it is an in-licensed product for Lupin and an out licensed one for Caplin Point for the US markets.
-
Lupin launches Thiamine Hydrochloride injection USP in US
19 Jun 2023 , 10:40AM
Lupin launches Thiamine Hydrochloride Injection or vitamin B1 to treat low levels of thiamine in the body
-
Lupin launches Darunavir tablets in the United States
5 Jun 2023 , 10:21AM
Lupin up on launhching Darunavir tablets in US
-
Lupin
5 Jun 2023 , 10:14AM
Lupin has launched Darunavir tablets 600 mg and 800 mg, a generic equivalent of Prezista tablets of Janssen Products LP. The drug has annual sales of USD 308 million in the US as per IQVIA MAT March 2023 report. It’s a limited competition product. Highly positive for the company.
-
Lupin
2 Jun 2023 , 11:20AM
Lupin has received approval from the USFDA for its ANDA for Diazepam Rectal gel Rectal Delivery system 10 mg and 20 mg, a generic of Diastat AcuDial Rectal Delivery system 10 mg and 20 mg of Bausch Health US, LLC. Diazepam Rectal Gel (RLD Diastat AcuDialTM) had estimated annual sales of USD 34 million in the U.S. (IQVIA MAT Mar 2023). Positive read through for the stock. We have a Reduce rating on the shares though.
-
Lupin
1 Jun 2023 , 10:07AM
Lupin has received approval from the USFDA for its ANDA for Obeticholic Acid Tablets a generic of Ocaliva of Intercept Pharma Inc. It will be manufactured in its Nagpur facility. Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of USD 262 million in the U.S. (IQVIA MAT Mar 2023). Strong positive as it will be the first generic of it. We have a Reduce rating on the shares with a PT of Rs. 700.
-
Lupin
31 May 2023 , 9:52AM
Lupin Ltd.: Lupin announced a strategic collaboration with Enzene Biosciences to launch Cetuximab in India, a biosimilar. Positive read-through for the stock. We have a Reduce rating on the shares though.
-
Lupin
29 May 2023 , 10:02AM
The company received approval from Health Canada to market generic version of tiotropium bromide inhalation powder under the name Spiriva for treatment of chronic obstructive pulmonary disease in Canada. Positive read through for the stock.
-
Lupin
8 May 2023 , 10:29AM
Lupin Ltd. announced the acquisition of the entire share capital of the French pharma company called Medisol, which was founded in 2011 and is engaged in generic injectables for France market. The acquisition will enable Lupin to gain access to 7 of Medisol’ s injectables across pain management, anti-inflammatory, cardiovascular diseases, and obstetrics therapies. Positive read through for the stock. However, we have Reduce rating on the shares with a PT of Rs. 660
-
Lupin Diagnostics launches regional reference laboratory in Bengaluru
13 Apr 2023 , 12:05PM
The new laboratory marks a significant step forward in Lupin Diagnostics
-
Lupin
13 Apr 2023 , 11:02AM
In a follow-up to the Form 483 issued on the company’s Pithampur plant at the end of March 23, the media furnishes the observations stating that 4 out of 10 observations are repeat observations. The same plant was given warning letter in Nov 2017. Its sentimentally negative.
-
Lupin
12 Apr 2023 , 1:49PM
Lupin Ltd. announced the launch of its new state of the art Regional Reference Laboratory in Bangalore, Karnataka as a part of the expansion of its diagnostics network. It is in addition to the 25 reference laboratories and 410+ collection centres across India. Positive development.
-
Lupin
3 Apr 2023 , 1:06PM
Lupin receives approval from the USFDA for Tenofovir Alafenamide tablets 25 mg (indicated for hepatitis B) a generic of Vemlidy 25 mg of Gilead Sciences. It will be manufactured at Lupin's Nagpur facility. Tenofovir had estimated annual sales of USD 531 million as of Dec 22 as per IQVIA MAT vs. USD 484 million market size it had in April 22 when Lupin first received the Tentative Approval for it. Highly positive as Lupin will be the first generic manufacturer of the RLD. We have a Hold rating on the stock.
-
Lupin
31 Mar 2023 , 2:35PM
Lupin Ltd. has received approval from the USFDA for its ANDA for Tenofovir Alafenamide tablets 25 mg, a generic equivalent of Vemlidy tablets 25 mg of Gilead Sciences, Inc. This product will be manufactured at Lupin’s Nagpur facility in India. Tenofovir Alafenamide 25 mg had estimated annual sales of USD 531 million in the US (IQVIA MAT December 2022). Positive read through for the stock.
-
Lupin receives nod from USFDA for Tenofovir Alafenamide Tablets
31 Mar 2023 , 12:50PM
Lupin receives USFDA nod for Tenofovir Alafenamide tablets used to treat Chronic Hepatitis B virus
-
Lupin
31 Mar 2023 , 12:26PM
Lupin has informed that its Pithampur Unit 2 manufacturing facility has been inspected by the USFDA and issued form 483 with 10 observations. Negative read through for the stock. We have a Reduce Rating on the shares with a PT of Rs. 660.
-
Lupin
27 Mar 2023 , 11:05AM
Lupin announced successful completion of the inspection for the UK Medicines and Healthcare products Regulatory Agency (UK MHRA) at its Pithampur facilities in India. Positive development for the stock. It has also completed a post marketing Adverse Drug Experience (PADE) inspection of the company's operations, which closed with no observations. Positive development for the stock.
-
Lupin
27 Mar 2023 , 10:33AM
Lupin gets tentative nod from USFDA for Valbenazine Capsules
-
Lupin gets tentative nod from USFDA for Valbenazine Capsules
27 Mar 2023 , 10:31AM
Valbenazine Capsules estimate annual sales of USD 1,235 million in the U.S
-
Lupin
24 Mar 2023 , 11:57AM
Lupin announced that it has received Tentative approval for its ANDA, Obeticholic Acid Tablets 5 and 10 mg to market a generic equivalent of Ocaliva tablets for the same strengths of Intercept Pharmaceuticals Inc. The drug had annual sales of USD 255 million in the US as per IQVIA MAT as of Dec 22. Positive for the company as this ANDA was a Paragraph IV certification filing that can make Lupin as the first generic of the Ocaliva tablets and get 180 days marketing exclusivity for it once Lupin gets the final appro
-
Lupin gets tentative USFDA approval for Obeticholic Acid Tablets
24 Mar 2023 , 10:12AM
Company gets tentative USFDA approval for its Abbreviated new Drug Application
-
Lupin
21 Mar 2023 , 9:47AM
Lupin Limited announced that its alliance partner Caplin Steriles Limited has received final approval from the USFDA for its ANDA, Thiamine Hydrochloride Injection USP, 200 mg/2 mL (100 mg/mL) Multiple-dose Vials, to market a therapeutically equivalent to the reference listed drug (RLD), Thiamine Hydrochloride Injection USP 200 mg/2 mL (100mg/mL) of Fresenius Kabi USA LLC. Thiamine Hydrochloride Injection USP had an annual sale of approximately USD 36 million in the U.S. (IQVIA MAT for the 12-month period ending December 2022). Positive development for the stocks like Lupin and Caplin Point.
-
Lupin Digital Health unveils results of Digital Therapeutics Study with ACS patients
17 Mar 2023 , 2:22PM
Lupin Digital Health unveils results of India’s First Digital Therapeutics Study with ACS Patients
-
Lupin
17 Mar 2023 , 2:17PM
Lupin Digital Health Ltd., a therapeutics platform, has unveiled the results of its study in India, showing the efficacy of Digital Therapeutics (DTx) (Lyf) among patients with acute coronary syndrome (ACS) and post percutaneous coronary intervention. The study findings were presented at the India Live 2023 symposium in Chennai. The patients enrolled in the program demonstrated significant improvement with 90% adhering to the recommended medication, diet, and exercise regimen. Nearly 83.3% of patients maintained their vital signs within normal range and no re-hospitalization occurring during the first 30 days of enrolment. Positive read through for the stock
-
Lupin
14 Mar 2023 , 9:36AM
Lupin Bioresearch Centre completes the 7th consecutive inspection of its Bioresearch centre in Pune, by the USFDA, which conducts BA/BE, PK/CD, In vitro BE, and biosimilar studies. The inspection closed without any observations. Positive read through for the stock.
-
Lupin
13 Mar 2023 , 12:02PM
Lupin completed its pre-approval and GMP inspection by the USFDA of the company's API manufacturing facility at Vishakhapatnam, Vizag. The inspection concluded with no observations. Positive read through for the stock.
-
Lupin
1 Mar 2023 , 2:43PM
Lupin has launched its new Regional Reference Laboratory in Hyderabad, Telangana. It is a part of the company’s strategy to build and strengthen its presence in South India. The addition leads to Lupin’s Diagnostics existing network reaching to 380+ LupiMitra collection centres and 23 labs across India. We have a Reduce rating on the shares.
-
Lupin
24 Feb 2023 , 11:15AM
Lupin’s short term credit rating has been reaffirmed to A+ by ICRA considering its position as one of the leading pharma players in India, its diversified revenue base, and global leadership in several APIs supported by its liquidity and balance sheet position. However, US business continued to remain impacted by price erosion. Neutral to marginally positive read through for the stock.
-
Lupin
22 Feb 2023 , 9:19AM
Lupin Ltd. announced the launch of Lurasidone Hydrochloride tablets, which is a generic of Latuda tablets of Sunovion Pharma Inc. The tablets had an estimated annual sale of USD 4.2 billion in the US (IQVIA MAT Dec 22) It’s a positive read through for the stock.
-
Lupin launches Lurasidone Hydrochloride tablets in the United States
21 Feb 2023 , 2:29PM
Lurasidone Hydrochloride is used to treat certain mental/mood disorders
-
Lupin
17 Feb 2023 , 10:45AM
Lupin Ltd. has received an Establishment Inspection Report (EIR) from the USFDA for its new injectable facility located at Nagpur, India. The EIR was issued post the last inspection of the facility conducted from Oct 17, 2022 – Oct 29, 2022. Positive
-
Lupin receives EIR from USFDA for its Injectable Facility in Nagpur
17 Feb 2023 , 10:13AM
The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022
-
Lupin
9 Feb 2023 , 11:14AM
Lupin Ltd. announced that it has received approval from the USFDA for its ANDA for Glycopyrrolate Injection USP, a generic equivalent of Robinul Injection, 0.2 mg/ml of Hikma Pharmaceuticals Inc. It is the first such approval from its new injectable facility at Nagpur, India. The approved product had estimated annual sales of USD 39.0 million in the US. (IQVIA MAT December 2022). Positive read through for the stock.
-
Lupin gets nod from USFDA for Glycopyrrolate Injection, USP
9 Feb 2023 , 10:50AM
Lupin gets USFDA nod for Glycopyrrolate Injection USP used to treat ulcers in adults, children
-
Lupin
6 Feb 2023 , 2:40PM
Drug maker Lupin has recalled 5,720 tubes of a cream used in the treatment of various skin conditions, such as dermatitis, eczema and psoriasis, from the US market due to a manufacturing issue, according to the US Food and Drug Administration. The affected lot has been manufactured at the company's Pithampur plant in Madhya Pradesh. Since the company has initiated the Class III nationwide (US) recall of the affected lot on January 23, it is a marginally negative to neutral read through
-
Lupin
31 Jan 2023 , 12:27PM
Lupin Ltd. announced that it has received Tentative Approval from the USFDA under the US’ President’s emergency plan for AIDS relief (PEPFAR) for its New Drug Application (NDA) for Dolutegravir, Emtricitabine, and Tenofovir Alafenamide (DEFTAF) tablets. It will be manufactured at Lupin’s Nagpur facility. Positive read through for the stock.
-
Lupin arm launches digital therapeutics solution
24 Jan 2023 , 1:48PM
Lupin launches LYFE, its Digital Therapeutic Solution for Holistic Heart Care
-
Lupin
24 Jan 2023 , 1:41PM
Lupin Digital Health Ltd., a wholly owned subsidiary of Lupin Ltd. announced the launch of its digital therapeutics’ solution, LYFE. It is a heart care program that can reduce the risk of a heart attack and improve vitals and quality of life for cardiac patients as it will enable monitoring through connected devices. Positive read through for the stock
-
Lupin
19 Jan 2023 , 9:49AM
Lupin Ltd. announced the launch of combination drug Sacubitril and Valsartan under two brands, Valentas and Arnipin in India. It is a generic of Vyamada brand of Novartis
-
Lupin
16 Jan 2023 , 3:22PM
Lupin has received tentative approval for the company’s ANDA for Dolutegravir and Rilpivirine tablets 50 and 25 mg to market a generic of Juluca tablets 50 mg/25 mg of ViiV Healthcare Company. Juluca had estimated annual sales of USD 666 million in the US as per IQVIA MAT Sep 22.
-
Lupin gets tentative USFDA nod for Dolutegravir & Rilpivirine tablets
16 Jan 2023 , 2:07PM
Dolutegravir & Rilpivirine combination is used to treat HIV infection
-
Lupin
12 Jan 2023 , 10:14AM
Lupin has been focusing on optimization of direct and indirect costs such as plant operating expenses, frieght, FTS, and low margin SKUs. The company is investing in the US to maintain leadership position in the US Gx market, is expected to outperform IPM and has a strong growth momentum for emerging markets. The company has respiratory and biologics portfolio of products to drive its growth as well. The company expects to have consolidated sales of USD 2.5 - 3.0 billion by FY25E and consolidated EBITDA of 18-20%. It was mentioned at a JP Morgan Health Conference.
Impact: Marginally positive.
-
Lupin
11 Jan 2023 , 9:35AM
Lupin received approval from the USFDA for its ANDA Prasugrel tablets USP, a generic of Effient tablets of Cosette Pharma Inc. with an annual sale of USD 18 million in the US. Our view: Positive as the generic competition is lower in the drug.
-
Lupin gets USFDA nod for ANDA Prasugrel Tablets
10 Jan 2023 , 2:59PM
Prasugrel is used to prevent strokes, heart attacks
-
Lupin, Exeltis announce reimbursement nod of NaMuscla in Spain
10 Jan 2023 , 12:29PM
NaMuscla is the first and only licensed product for this indication in Europe
-
Lupin
10 Jan 2023 , 11:00AM
Lupin and Exeltis Healthcare S.L. got approval from the Spanish Ministry of Health for the reimbursement of Lupin’s NaMuscla drug, for the symptomatic treatment of myotonia (which is a muscle dysfunctioning) in adults. The drug is the first and only licensed product for this indication in Europe and will be marketed by Lupin’s partner Exeltis in Spain. Our view: This is highly positive as myotonic dystrophy market is expected to grow at 7.6% CAGR during CY22-CY28 across the world. Being the indication for rare diseases make them highly costly. Getting a reimbursement from the government will make it more affordable thereby increasing its offtake.
-
Lupin
9 Jan 2023 , 10:59AM
Lupin announced on Friday, post market, that it has received an USFDA approval for its ANDA, Fesoterodine Fumarate Extended-Release tablets, 4 mg, and 8 mg, to market a generic of Toviaz tablets of Pfizer Inc. It will be manufactured at Lupin's Goa facility. It had annual sales of USD 177 million in the US as per IQVIA MAT September 2022. Our view: It is positive as Toviaz tablets has only 4 generic players such as Alkem Labs, Aurobindo, Dr. Reddy’s, and Zydus Pharma, manufacturing it so far.
-
Lupin
5 Jan 2023 , 12:12PM
Lupin Ltd. announced the launch of a novel fixed dose triple drug combination (FDC) of Indacaterol, Glycopyrronium and Mometasone for managing inadequately controlled asthma amongst patients. The product is launched under the brand name DIFIZMA in India. Lupin is the first company to offer this novel FDC dry powder inhalation (DPI) product in India. DIFIZMA is the only FDC product that has been approved by DCGI in India. Our view: Positive development
-
Lupin launches triple drug combination of Indacaterol, Glycopyrronium & Mometasone
5 Jan 2023 , 11:19AM
Difizma is used to treat inadequately controlled asthma
-
Lupin
22 Dec 2022 , 1:42PM
Lupin announced launch of its Regional Reference Laboratory in Indore, Madhya Pradesh as a part of its expansion plan in Central India. Lupin Diagnostics operates over 325 LupiMitra (franchisee collection centers) and 23 laboratories in India. Our view: Positive as it marks the expansion into Central India for diagnostics business. Also Lupin Pharmaceuticals Inc. in the US has been recalling four lots of Quinapril Tablets to the patients due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. To date, Lupin has received no reports of illness that appear to relate to this issue. Our view: Marginally negative to neutral.
-
Lupin
21 Dec 2022 , 2:56PM
Lupin announced that it has received approval from the USFDA for its ANDA for Brivaracetam tablets 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, which is a generic equivalent of Briviact Tablets of UCB Inc. The product will be manufactured from Lupin’s Nagpur, India facility. Brivaracetam (RLD: Briviact) had estimated annual sales of USD 420 million in the US as per IQVIA MAT September 2022. Our view: Positive as there was no other generic of Briviact available before it.
-
Lupin gets USFDA approval for Brivaracetam tablet
21 Dec 2022 , 1:33PM
Brivaracetam is used to control partial onset seizures
-
Lupin launches authorized generic version of PENNSAID in the US
9 Dec 2022 , 2:36PM
Pennsaid is used to treat the pain of Osteoarthritis
-
Lupin
5 Dec 2022 , 2:34PM
Lupin announced the launch of Rufinamide Tablets USP 200 mg and 400 mg to market a generic equivalent of Banzel tablets 200 mg and 400 mg of Eisai Inc. Rufinamide tablets (RLD Banzel) had estimated annual sales of USD 138 million in the US as per IQVIA MAT October 2022.
-
Lupin launches Rufinamide Tablets USP in the United States
5 Dec 2022 , 1:54PM
Rufinamide Tablets had an estimated annual sales of $138 m in the US
-
Lupin
29 Nov 2022 , 12:58PM
Lupin: The company launches Formoterol Fumarate inhalation solution in the US used to control wheezing, shortness of breath, and chest tightness caused by Chronic Obstructive Pulmonary Disease (COPD). Formoterol Fumarate inhalation solution had an estimated annual sales of $268mn of the US business – Positive read through for the stock.
-
Lupin launches Formoterol Fumarate Inhalation Solution in US
29 Nov 2022 , 12:30PM
Formoterol Fumarate inhalation solution had est annual sales of $268 m in the US
-
Lupin
29 Nov 2022 , 10:06AM
Brazilian Subsidiary, MedQuimica Acquires Rights to Nine brands from Bausch Health
-
Lupin
25 Nov 2022 , 10:49AM
The USFDA has issued 8 observations for the drug product facility and API facility at Mandideep. The US drug regulator has inspected company's Mandideep unit-1 facility during November 14-23, 2022 – negative read through for the stock
-
Lupin
22 Nov 2022 , 10:57AM
The company has signed a Memorandum of Understanding (MoU) with the Government of Rajasthan to address the prevalence of Cardiovascular Disease (CVD) and Chronic Obstructive Pulmonary Disease (COPD) in the Alwar district of Rajasthan. The collaboration will work towards serving the local communities in Alwar through preventive, curative and support-based solutions focused on curing the diseases in the short term and reducing their prevalence in the long term. The program is planned to be rolled out in a phase-wise manner.
-
Lupin
20 Oct 2022 , 10:20AM
The company’s wholly owned subsidiary Lupin Inc., USA, has signed Definitive Agreement with Sunovion Pharmaceuticals Inc., USA for acquiring Brovana and Xopenex HFA, respiratory brands with an aim to expand its portfolio of Inhalation products. Lupin Inc. will purchase all assets required to manufacture and commercialize Brovana Inhalation Solution and Xopenex HFA Inhalation Aerosol in the United States for a cash consideration of $75 million. Acquisition is expected to be completed 2-3 weeks post signing. IQVIA sales for the two brands combined were approximately $60 Million (MAT August 2022). Additionally, inspection conducted by the USFDA at Lupin’s Biotech manufacturing facility in Pune in October 2022 concluded with the issuance of a Form 483 with seventeen observations. However, 483 letter is not expected to have any material impact on the existing revenues from operations of this facility.
-
Lupin
7 Oct 2022 , 12:59PM
The company has reached an agreement with Unitaid, the Aurum Institute, the Clinton Health Access Initiative (CHAI), and other global procurement agencies to support tuberculosis prevention treatment that will be rolled out to 138 countries, including many low-and middle-income countries with a large burden of TB. Through this agreement, Lupin will introduce two new formulations, a fixed-dose combination of Rifapentine + Isoniazid and Rifapentine 300 mg standalone tablets, at an affordable price. As a global leader in anti-TB medicines, Lupin is committed to ensuring its products are widely available in all countries and there is equitable access to treatment globally.
-
Lupin partners with global agencies
7 Oct 2022 , 12:16PM
Lupin partners with global agencies to increase patient access to Tuberculosis Prevention Treatment
-
Lupin
7 Oct 2022 , 11:54AM
The company announced the appointment of Dr. Shahin Fesharaki as Global Chief Scientific Officer. Dr. Fesharaki will be responsible for Lupin’s global research and development efforts across branded, generics and specialty products. With nearly 30 years' experience in drug development in leading global pharmaceutical companies, Dr. Fesharaki most recently served as the Chief Scientific Officer and Global Head of R&D for Hikma Pharmaceuticals. Prior to that Dr. Fesharaki held various leadership positions in Teva, Allergan/Actavis, Watson Pharmaceuticals and Apotex. Dr. Fesharaki has extensive development experience in both generic and branded pharmaceuticals across a broad range of technologies and dosage forms.
-
Lupin
4 Oct 2022 , 1:05PM
The company has received USFDA nod for Darunavir. Darunavir is used as a pharmacokinetic booster.
-
Lupin
3 Oct 2022 , 10:36AM
The company announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Ankleshwar manufacturing facility, located in Gujarat. The inspection of the facility was conducted from August 16-19, 2022 – Positive read through for the stock
-
Lupin launches Sildenafil in the United States
29 Sep 2022 , 2:45PM
Lupin Launches Sildenafil for Oral Suspension in the United States
-
Lupin gets Health Canada nod for Rymti
13 Sep 2022 , 2:42PM
Rymti is used to treat Rheumatoid Arthritis
-
Lupin introduces generic Suprep Bowel Prep kit in US
9 Sep 2022 , 11:15AM
Lupin launches Generic Suprep Bowel Prep Kit in the United States
-
Lupin, DKSH sign agreement to market 5 biosimilar candidates in Philippines
7 Sep 2022 , 10:54AM
Lupin, DKSH sign an exclusive licensing and supply agreement to Market Five Biosimilar Candidates in the Philippines
-
Lupin
30 Aug 2022 , 10:26AM
In partnership with Pharmascience Inc has announced that it has received tentative approval from the USFDA, for its ANDA Dasatinib Tablets in strengths - 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. The tablet used to treat a certain type of chronic myeloid leukemia as a first treatment. The addressable market size in the US for the tablets is substantial at $1569 mn as per IQVIA MAT June 2022. Given the healthy addressable market size the tentative approval is positive read thru
-
Lupin
29 Aug 2022 , 11:59AM
Launches Desvenlafaxin Extended release tablets strength 25 mg, in the US markets. The tablet Desvenlafaxine is used to treat depression and has an addressable market size of USD 14 mn as per IQVIA MAT June 2022. Though the addressable market size of the drug is relatively small, the launch would widen and product offerings in the US markets; Positive read thru
-
Lupin gets UK MHRA nod for Tiotropium Bromide inhalation powder
26 Aug 2022 , 12:19PM
Lupin announces UK MHRA Approval of Lutio for treatment of COPD
-
Lupin
26 Aug 2022 , 10:33AM
As per media reports the company gets a USFDA approval for its ANDA for Dasatinib Tablet. The tablet is used to treat a certain type of chronic myeloid leukemia, which is a type of cancer of white blood cells as a first line of treatment. Positive
-
Lupin in exclusive licensing agreement with Japan's I'rom Group for Denosumab
25 Aug 2022 , 12:08PM
Lupin and I'rom Enter into an Exclusive Licensing Agreement for Denosumab biosimilar for Japan
-
Lupin
25 Aug 2022 , 10:13AM
The company has announced the acquisition of two brands from Boehringer Ingelheim International GmbH - Ondero and Ondero - Met (including trademark rights associated with the brands). The acquired brands are in the diabetes segment and are used to treat type 2 diabetes. The acquisition is done for a cash consideration of Eur 26 million (~Rs 207 cr). Also Lupin has received USFDA approval for its ANDA Formoterol Fumarate Inhalation Solution strength - 20 mcg/2 mL per Unit-Dose Vial. The drug is used for treatment or prevention or decreasing of breathing problems caused by ongoing lung diseases.
-
Lupin acquires 'Ondero' & 'Ondero Met' from Boehringer Ingelheim Intl GmbH
25 Aug 2022 , 9:38AM
Lupin enters into Deed of Assignment with Boehringer Ingelheim International GmbH for the acquisition of brands Ondero and Ondero
-
Lupin
19 Aug 2022 , 10:42AM
Lupin: Gets USFDA approval for its ANDA - Rufinamide Tablets USP, 100 mg, 200 mg, and 400 mg. The tablets had an annual estimated sales of $164 mn as per IQVIA MAT June 2022. Considering the healthy addressable market size, ANDA approval is positive.
-
Lupin receives USFDA nod for Rufinamide tablets USP
18 Aug 2022 , 2:57PM
Rufinamide tablets are used to control seizures
-
Lupin receives nod from USFDA for Meclizine Hydrochloride tablets
12 Aug 2022 , 3:33PM
Meclizine is an antihistamine that is used to prevent and treat nausea
-
Lupin
4 Aug 2022 , 10:30AM
Lupin: reported a weak performance for Q1FY23 with the operating margins surprising negatively marred by confluence of factors like pricing pressures in the US and remediation cost at its plants. This coupled with the overall cost escalations, resulted in operating margins declining by 1552 bps yoy and consequently the company reported net loss of Rs 89 cr for Q1 as compared to Rs 505 cr profit in Q1FY22, while the sales declined by 12.3% yoy. The results missed estimates
-
Lupin
26 Jul 2022 , 10:38AM
Lupin: The company gets an USFDA approval for ANDA for Azilsartan Kamedoxomil tablets with the strength of 40 mg and 80 mg. The drug is indicated for the treatment of high blood pressures and hypertension and the addressable market size for the tablets is USD 101 mn as of IQVIA MAT March 2022. Given the healthy addressable market size the ANDA approval is positive
-
Lupin
25 Jul 2022 , 10:05AM
The company gets an USFDA approval for Azilsartan Kamedoxomil. The drug is indicated for the treatment of high blood pressures and hypertension. Positive
-
Lupin
20 Jul 2022 , 10:38AM
Lupin Diagnostics has launched its first Reference Laboratory in Ranchi that is equipped a broad spectrum of routine and specialized tests in various fields. People in Jharkhand can now avail preventive health check-ups, home collection and testing centres at 10 locations. In line with its strategy of serving the East India, the company has established the reference lab in Ranchi following the reference labs being set up in Assam, West Bengal and Bihar and the company already has 100 franchise collection centres for East India. Positive read thru
-
Lupin Diagnostics launches its first reference laboratory in Ranchi
19 Jul 2022 , 2:48PM
Lupin Diagnostics will equip doctors with accurate diagnosis in the patient journey
-
Lupin Somerset manufacturing plant receives EIR from USFDA
7 Jul 2022 , 10:17AM
USFDA determines inspection Classification Company’s Somerset facility is Voluntary Action Indicated
-
Lupin gets approval from USFDA for Paliperidone Extended-Release Tablets
1 Jul 2022 , 10:54AM
Paliperidone is mainly used to treat schizophrenia and schizoaffective disorder
-
Lupin
16 Jun 2022 , 2:32PM
The diagnostics arm – Lupin diagnostics has launched its first Regional Reference Laboratory in Patna. The new Regional Reference Laboratory at Patna has capabilities to conduct a broad spectrum of routine and specialized tests across fields. By establishing its presence in the Patna, the company now looks to deeper penetrate Bihar, while earlier it had forayed in Assam and West Bengal. Through upcoming launches of laboratories in Jharkhand (Ranchi) and Orissa (Bhubaneshwar), the company is poised to solidify its position in East India. The company operates 280 centers across India and close to 100 diagnostic centres in East India. Positive read thru
-
Lupin Diagnostics launches its first Regional Reference Laboratory in Patna
15 Jun 2022 , 4:39PM
Expanding diagnostics footprint in East India
-
Lupin
13 Jun 2022 , 9:45AM
As per media reports, The European Medicines Agency has recommended the withdrawal of marketing Authorization in the European Union for amfepramone obesity drug citing safety reasons. This is likely to impact Lupins sales in the EU region, hence negative
-
Lupin gets tentative USFDA nod for Ivacaftor Tablets
8 Jun 2022 , 2:23PM
Lupin receives tentative approval from USFDA for Ivacaftor Tablets
-
Lupin
6 Jun 2022 , 9:36AM
As per media reports more than 300 employees were terminated by the company from the jobs from one of its OSD (Oral Solid Dosages) plants in India, after the USFDA inspection in which the samples were rejected after the agency audit. The sacked employees have lodged a complaint against the company in the local police Station and the management has mentioned that they could consider the released employees for positions as needed from time to time, but we await further clarity on this from the company.
-
Lupin
9 May 2022 , 9:33AM
Gets USFDA approval for its ANDA - lloperidone Tablets in multiple strengths of – 1mg, 2mg, 4mg, 6mg, 8mg, 10mg, and 12mg. The lloperidone Tablets have been indicated for treating mental disorders and the products had estimated US sales of $162 mn in the US as of MAT March 2022. Also Lupin received another approval from USFDA for its ANDA – Pregabalin capsules in the strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg. Pregabalin capsules are used to treat epilepsy and anxiety. The product has an estimated addressable market size of $263 mn in the US as of MAT March 2022. Given the healthy addressable market size, the ANDA approvals are positive.
-
Lupin
2 May 2022 , 12:52PM
Lupin diagnostics has launched a reference Laboratory in Guwahati – North East India. The reference lab has capabilities to conduct a broad spectrum of routine and specialized tests. The expansion is in line with the company’s strategy to expand its presence pan India and there increase access to quality testing in India. Positive read thru
-
Lupin, Yabao announce Strategic Partnership in China
27 Apr 2022 , 10:28AM
Lupin Global enters into a strategic partnership with Chinese co Yabao Pharma, for drugs with Pediatric formulations in Chinese market
-
Lupin
19 Apr 2022 , 9:55AM
Lupin: gets a tentative approval from the USFDA for ANDA Tenofovir Alafenamide Tablets, 25 mg, which is a generic equivalent of Vemlidy tablets. The tablets are used to treat chronic hepatitis B virus infection in adults with compensated liver disease. The tablets had an estimated annual sales of $ 484.2 million in the US, which is a sizeable addressable market size hence positive read thru.
-
Lupin
8 Apr 2022 , 12:43PM
Lupin: has launched Merzee capsules strength - 1 mg/20 mcg, in the US market, under exclusive license, marketing and distribution agreement with Slayback Pharma LLC. Reference listed drug Taytulla had estimated annual sales of $90 million in US, which is sizeable addressable – hence the launch is positive
-
Lupin Completes Acquisition of Brands from Anglo-French
7 Apr 2022 , 11:28AM
Lupin completes acquisition of a portfolio of brands from Anglo-French Drugs & Inds
-
Lupin
5 Apr 2022 , 3:16PM
Lupin: The USFDA has inspected Lupin’s Tarapur manufacturing plant between 22 March 2022 to 4th April 2022. The inspection ended with 4 observations being issued by the USFDA and the management seems confient of addressing the same. However receipt of 4 observations is negative read thru
-
Lupin
4 Apr 2022 , 12:11PM
Lupin: on 18th January 2022, The board of directors of Lupin had approved the acquisition of portfolio of brands from Anglo-French Drugs & Industries Limited and its associates in the Vitamins, Minerals and Supplements and CNS segment. Lupin has now announced that it has entered in to an agreement with Anglo-French Drugs & Industries Limited for the said agreement. The acquisition could strengthen Lupin’s presence in these segments.
-
Lupin
1 Apr 2022 , 9:54AM
Lupin: The USFDA has inspected the company’s manufacturing plant located at Somerset (US) between 7th March 2022 to 30 March 2022. The inspection has ended with 13 observations and the management looks confident of addressing the same. The Somerset plant contributes less than 5 % of the company’s global revenues and the management believes that the observations would not result in any supply disruptions from the plant. However, we believe that the receipt of 13 observations is negative read thru
-
Lupin receives approval from USFDA for Sildenafil for Oral Suspension
24 Mar 2022 , 1:57PM
The product will be manufactured at Lupin's facility in Goa, India
-
Lupin
14 Mar 2022 , 1:13PM
Lupin: Gets USFDA approval for its ANDA - Vigabatrin for Oral Solution USP, strength 500 mg. The product is used to treat infantile spasms in babies and children between the age of 1 month and 2 years. The reference listed drug - Sabril has estimated annual sales of $275 mn in the US as of December 2021. Given the sizeable addressable market size the approval is positive
-
Lupin
11 Mar 2022 , 12:15PM
Lupin diagnostics has launched its first ever reference laboratories in East India Kolkata. The new reference lab has the capabilities to conduct a broad spectrum of routine and specialized tests in the fields of molecular diagnostics, cytogenetics, flow cytometry, histopathology, cytology, microbiology, serology, haematology, immunology and routine biochemistry. Also Lupin Diagnostics is also setting up laboratories in West Bengal, Assam, Bihar, Jharkhand and Orissa to comprehensively cater to the East India region. Setting up of a reference lab in Kolkata would support the geographic expansion in east India for Lupin diagnostics, hence is Positive read thru
-
Lupin launches its first reference laboratory in East India
11 Mar 2022 , 9:44AM
Lupin introduces its First Reference Laboratory in East India establishing its Diagnostics Business in Kolkata
-
Lupin
3 Mar 2022 , 3:30PM
Lupin: gets USFDA approval for its ANDA - Efinaconazole Topical Solution, 10%. The solution is used to treat fungal or yeast infection of toenails. Efinaconazole Topical Solution had estimated annual sales of USD 274 million in the US. Given the strong addressable market size the approval is positive
-
Lupin receives approval from USFDA for Efinaconazole Topical Solution
3 Mar 2022 , 3:08PM
Lupin Global gets USFDA nod for Efinaconazole Topical Solution, used for treatment of fungal or yeast infection of the toenails
-
Lupin
2 Mar 2022 , 11:32AM
Sevelamer Hydrochloride Tablets, 800 mg, a generic equivalent of Renagel. The tablets are used to treat hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Sevelamer Hydrochloride Tablets had estimated annual sales of $75 mn in the US. Given the healthy addressable market size the launch is positive
-
Lupin
2 Mar 2022 , 11:30AM
Sevelamer Hydrochloride Tablets, 800 mg, a generic equivalent of Renagel. The tablets are used to treat hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Sevelamer Hydrochloride Tablets had estimated annual sales of $75 mn in the US. Given the healthy addressable market size the launch is positive
-
Lupin
18 Feb 2022 , 10:37AM
Lupin has announced that the U.S. Food and Drug Administration has approved the company’s supplemental New Drug Application (sNDA) to expand the use of SOLOSEC® (secnidazole) in the treatment of bacterial vaginosis (BV) for female patients 12 years of age and older and in the treatment of trichomoniasis for all patients 12 years of age and older. Positive read through for Lupin
-
Lupin receives USFDA approval for antibiotic Solosec
18 Feb 2022 , 9:48AM
Lupin announces USFDA acceptance for bacterial vaginosis drug
-
Lupin
10 Feb 2022 , 9:43AM
Lupin: has entered into a distribution agreement with Medis for its orphan drug NaMuscla, indicated for he symptomatic treatment of myotonia in adults with non-dystrophic myotonic disorders. NaMuscla is the e first and only licensed product for treating the indication. As per agreement Medis would commercialise the product in Central and Eastern Europe. Positive
-
Lupin Q3FY2022: Weak quarter
4 Feb 2022 , 9:47AM
Lupin Q3FY2022: Weak quarter; Operating performance misses’ estimates
-
Lupin
28 Jan 2022 , 9:52AM
Alongwith Exeltis USA Inc. Lupin announced a promotional agreement for Exeltis to promote SOLOSEC along with Exeltis’ existing line of Women’s Health products. SOLOSEC is indicated for the treatment of Bacterial Vaginosis in adult women and Trichomoniasis in adults. The agreement would enable to expand the reach of Solosec and also improve the accessibility for the patients.
-
Lupin signs first partnership agreement with Foncoo for China
21 Jan 2022 , 10:11AM
Lupin enters into a partnership with Shenzhen Foncoo Pharmaceutical
-
Lupin
19 Jan 2022 , 11:06AM
Lupin: has entered into a partnership with Shenzhen Foncoo Pharmaceutical Co. Ltd, China to launch high quality generic and complex generic medicines in China markets. Foncoo’s successful experiences of importing registration and marketing of the generic formulations and Lupin’s strong capability of making high quality medicines make the partnership a perfect match and points at possible growth opportunities for Lupin. The partnership is in line with Lupin’s strategy of investing in key growth markets including China and hence Positive
-
Lupin signs first partnership agreement with Foncoo for China
19 Jan 2022 , 10:52AM
Lupin enters into a partnership with Shenzhen Foncoo Pharmaceutical (Foncoo)
-
Lupin
18 Jan 2022 , 3:55PM
The board of directors of the company has approved the acquisition of portfolio of brands from Anglo-French Drugs & Industries Limited and its associates in the Vitamins, Minerals and Supplements and CNS segment, which would strengthen Lupin’s presence in these segments.
-
Lupin launches Molnupiravir under the brand name Molnulup
7 Jan 2022 , 10:08AM
Lupin launches Molnupiravir under the brand name Molnulup for the treatment of COVID-19 in adults in India
-
Lupin
27 Dec 2021 , 11:46AM
Lupin: gets USFDA approval for its ANDA - Sevelamer Carbonate for Oral Suspension, 0.8 g and 2.4 g packets. The drug is indicated for control of serum phosphorus in adults and children 6 years of age and older suffering from chronic kidney disease on dialysis. The reference listed drug Renvela had estimated annual sales of USD 51.7 mn MAT in the US as of September 2021 as per IQVIA. Further the product would be manufactured at the Goa plant and consequently is a first product to be approved post receipt of the EIR from the USFDA and hence Positive.
-
Lupin receives tentative nod from USFDA for Azilsartan Medoxomil Tablets
24 Dec 2021 , 10:33AM
The product will be manufactured at Lupin's Nagpur facility in India
-
Stock Update: Lupin
21 Dec 2021 , 10:56AM
Stock Update: Lupin - Goa EIR provides respite; long-term growth levers intact
-
Stock Update: Lupin
21 Dec 2021 , 10:54AM
Stock Update: Lupin - Goa EIR provides respite; long-term growth levers intact
-
Lupin
14 Dec 2021 , 11:25AM
The Goa plant of the company has received an Establishment Inspection Report (EIR)from the USFDA (Plant inspected in September 2021). The USFDA has determined the inspection classification of the facility as VAI (Voluntary Action Indicated). The Goa plant of the company houses key product fillings for the US markets and with the receipt of the EIR the new launch momentum in the US markets is expected to improve and this could partially offset the high competitive pressures and add to the US top-line growth. – Positive
-
Lupin's Goa manufacturing plant receives EIR from USFDA
14 Dec 2021 , 10:25AM
Receives EIR from USFDA with Voluntary Action Indicated classification for our Goa plant
-
Lupin
13 Dec 2021 , 12:10PM
Lupin: US-based arm is recalling 4,113 cartons of generic oral contraceptive tablets from the US markets - Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg). The company is recalling the lot due to it being "Subpotent Drug" and as per the USFDA, the recall is classified as a Class III recall, hence unlikely to have any material impact on the financial performance of the company
-
Lupin
10 Dec 2021 , 2:30PM
Lupin: Has announced the launch of diagnostic services – Lupin Diagnostics in India, which is a part of its strategy to provide integrated healthcare services. It has established a state-of the-art 45,000 sq. ft National Reference Laboratory in Navi Mumbai with experienced doctors and trained technologists and capability to offer comprehensive range of diagnostic tests. Healthcare services are gaining an increasing importance post the advent of the pandemic and diagnostics services are an integral part of it. Lupin’s entry in the diagnostics space provides a new growth avenue and in the process would diversify the revenue base, hence potentially positive.
-
Lupin announces launch of its Diagnostics business
10 Dec 2021 , 2:04PM
The company establish 45,000 sq.ft National Reference Laboratory in Navi Mumbai
-
Lupin
6 Dec 2021 , 10:47AM
Lupin: The company has entered in to exclusive distribution and marketing agreement with Biomm SA in Brazil. As per the terms of the agreement Biomm SA would distribute and market biosimilar Pegfilgrastim in Brazil. Earlier Lupin had received an approval from the USFDA for the BLA (Biologics License Application) for its proposed biosimilar to Neulasta (pegfilgrastim). The agreement is positive as it could help improve the geographic reach for the biosimilar.
-
Lupin partners with TTP plc UK for Soft-mist Inhalation Technology Platform
2 Dec 2021 , 11:38AM
Lupin subsidary, TTP PLC sign deal to develop soft-mist inhalation technology platform
-
Lupin launches educational mobile adaptable website for medical students
30 Nov 2021 , 12:57PM
Lupin launches Sciflix a mobile-friendly learning platform for post graduate students specializing in pulmonology
-
Lupin
18 Oct 2021 , 10:48AM
Lupin: Has voluntarily recalled all batches of lrbesartan Tablets and lrbesartan and Hydrochlorothiazide Tablets in the US markets due to presence of impurities - N-nitrosolrbesartan, which were found in the API of the medicine. Being a voluntary recall, it is unlikely to have any material impact on the financials of the company.
-
Lupin
7 Oct 2021 , 1:12PM
Gets USFDA tentative approval for its ANDA - Brexpiprazole Tablets strengths - 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. The tablets are used to reat the symptoms of schizophrenia as well as is also used with an antidepressant to treat depression. Brexpiprazole Tablets have an estimated annual sales of $1258 mn in the US as per IQVIA MAT July 2021. Given the strong addressable market size for the product, the tentative approval is positive
-
Lupin receives tentative approval from USFDA for Brexpiprazole Tablets
7 Oct 2021 , 12:32PM
Lupin gets tentative approval from the USFDA for its ANDA Brexpiprazole Tablets
-
Sun Pharma, Lupin
1 Oct 2021 , 9:39AM
New Jersey federal judge has invalidated a Sun Pharmas patent on a branded treatment to prevent pain in eye surgery patients post cataract surgery. The suit was a part of intellectual property fight between Sun pharma and Lupin and pertains to Sun pharma’s product bromiside. Lupin has requested approval from the federal government to market a generic version of the brand-name product, which has resulted in Sun Pharma to file suit alleging patent infringement. Though this is sentimentally negative for both Sun pharma and Lupin, we await further clarity on this
-
Lupin launches Droxidopa capsules in the United States
29 Sep 2021 , 10:56AM
Indicates for the treatment of orthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" in adult patients with symptomatic
neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure
-
Lupin falls as USFDA issues seven observation
20 Sep 2021 , 11:06AM
Lupin dips by 4% to Rs. 913, after receiving final nod from the USFDA to market Vortioxetine Tablets
-
Lupin
20 Sep 2021 , 10:22AM
Lupin- Gets 7 USFDA Observations at Goa facility unit was earlier inspected by USFDA- Sentimentally negative.
-
Lupin launches authorized generic version of Duexis in the United States
15 Sep 2021 , 3:24PM
Lupin launches the authorised generic version of Duexise tablets, a nonsteroidal anti-inflammatory drug (NSAID) in the US
-
Lupin
6 Sep 2021 , 1:53PM
TB alliance, a non profit drug developer has granted Lupin a non-exclusive license to manufacture the anti-TB drug pretomanid as part of the three-drug regimen. Lupin intends to commercialize the anti-tuberculosis medicine in approximately 140 countries and territories, including many of the highest TB burden countries around the world, hence positive.
-
Lupin Global, TB Alliance announce commercial partnership for new therapy
6 Sep 2021 , 10:40AM
TB Alliance and Lupin announce commercial partnership for new therapy for Highly Drug-Resistant TB
-
Lupin launches Luforbec for treatment of Asthma & COPD
24 Aug 2021 , 2:10PM
Luforbec use for the treatment of asthma and for severe chronic obstructive pulmonary disease
-
Lupin receives tentative USFDA approval for Brivaracetam tablets
17 Aug 2021 , 12:13PM
Brivaracetam Tablets indicates for the treatment of partial-onset seizures in patients four years of age and older
-
Lupin
17 Aug 2021 , 9:34AM
Lupin: Gets tentative approval from the USFDA for its ANDA - Brivaracetam Tablets strengths: 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg. The tablets are indicated for treatment of partial-onset seizures in patients four years of age and older. The reference listed drug – Briviact tablets have an estimated annual sales of $311 mn in the US as of June 2021 – IQVIA MAT. Also Lupin is looking for manufacturing partners in China and plans to enter China markets with few of its respiratory products which have been commercialized in other regulated markets or in pipeline. Both the receipt of tentative approval (due to sizeable addressable market opportunity) and plans to enter the China markets are positive.
-
Lupin: Stock update
12 Aug 2021 , 11:51AM
Lupin: Stock update - long-term growth levers intact
-
Lupin Q1FY2022
11 Aug 2021 , 10:19AM
Lupin Q1FY2022: Operating performance marginally misses estimates
-
Lupin
30 Jul 2021 , 12:32PM
The company’s Australian Subsidiary – Generic health has entered into a definitive agreement under which Lupin will acquire 100% of the shares of Southern Cross Pharma Pty Ltd (SCP), which is engaged in developing, registering, and distributing generic products. Generic Health will gain access to over 60 registered products having sales of over AUD 30 Mn (approximately USD 22 Mn). This will significantly increase Lupin’s value proposition and market share in the Australian market. The acquisition is aligned with Lupin’s strategy to expand and deepen presence in select markets of focus. The transaction is expected to be completed in the 5-6 months time frame. Given the synergies mentioned above, the acquisition is positive
-
Lupin acquires Southern Cross Pharma in Australia
30 Jul 2021 , 11:37AM
Lupin's arm Generic Health to acquire Southern Cross Pharma
-
Lupin
15 Jul 2021 , 10:45AM
As per media news, Vertex Pharmaceuticals has said that Lupins proposed generic version of Kalydeco, which is used for treatment of cystic fibrosis, infringes a patent for the drug. Accordingly Vertex is seeking a court order blocking copies of the drug until the patent expires and has filed a complaint in the feder-al court of Delaware. The Patent for the said drug was issued in May 2020 and expires in August 2029. We await further clarity on this from Lupin.
-
Lupin launches Tavaborole Topical Solution in the US
13 Jul 2021 , 2:37PM
Lupin launches Tavaborole Topical solution in the US market, used to treat onychomycosis of the toenails
-
Lupin
2 Jul 2021 , 9:41AM
Gets USFDA approval for its supplemental New Drug Application (sNDA) to expand the use of SOLOSEC to include the treatment of trichomoniasis in adults. Trichomoniasis is the most common non-viral infection in the U.S affecting an estimated three to five million people every year. The supplemental approval makes SOLOSEC® the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV (bacterial Vaginosis). The approval of the sNDA is positive and would add to the US topline which accounts for 37% of the overall FY2021 sales
-
Lupin
30 Jun 2021 , 4:02PM
Lupin: The company had received a warning letter from the USFDA for its somerset plant and the warning letter mentions the corrective actions required to be taken at somerset which includes strengthening the cleaning and maintenance procedures, strengthening the manufacturing process validations and a robust quality unit oversight. The company would be working towards addressing the observations, but the warning letter also mentions of repeat violations at multiple sites demonstrates that the company’s oversight and control over manufacturing process is inadequate. Lupin’s other plants at Goa and Indore are already under USFDA scrutiny and these observations could result in a delay in the resolution of the warning letter at these plants as well.
-
Lupin Global gets tentative USFDA approval for a combination drug to treat HIV
30 Jun 2021 , 10:18AM
Lupin receives tentative USFDA nod for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate tablets under PEPFAR
-
Lupin
28 Jun 2021 , 9:33AM
Lupin: Has launched Emtricitabine and Tenofovir Disoproxil Fumarate Tablets Strength - 200 mg/300 mg, which is approved by the USFDA. The Tablets are are the generic equivalent of Truvada tablets and indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. The reference Listed Drug Truvada tablets had estimated annual sales of USD 2.1 billion in the U.S as of IQVIA MAT March 2021. Given the sizeable addressable market size the product launch is positive.
-
Lupin
25 Jun 2021 , 10:22AM
Otsuka sues Lupin in the court of Delaware (US) over versions of kidney treatment drug - Jynarque proposed by Lupin. Otsuka has claimed that Lupin’s version of the drug infringes two patents for the drug and Otsuka is seeking court order blocking copies of the drug until patents have expired. The patents are set to expire in September 2026 and April 2030. The filling of the legal suit in the Delaware court is negative for Lupin.
-
Lupin
17 Jun 2021 , 3:23PM
Lupin: Gets USFDA approval for Sevelamer Hydrochloride Tablets strength - 400 mg and 800 mg. The Tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. The reference listed drug – Renagel had an estimated annual sales of $ 80 mn in the US as of March 2021 MAT. The approval is positive for Lupin as it would add to the US sales growth
-
Lupin receives USFDA nod for Sevelamer Hydrochloride Tablets
17 Jun 2021 , 3:20PM
Sevelamer Hydrochloride Tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis
-
Lupin receives UK marketing authorization for Luforbec
14 Jun 2021 , 1:49PM
Luforbec is for regular treatment of asthma and for the symptomatic treatment of patients with severe chronic obstructive pulmonary disease
-
Lupin
14 Jun 2021 , 10:17AM
LUPIN: The USFDA has issued a warning letter to the company’s Somerset (New Jersey, US). The plant was inspected in between September 10, 2020 to November 5, 2020 and earlier was given 13 observations. As per the management the warning letter would be have any impact on the supplies or revenue from operations. However the receipt of the warning letter is negative.
-
Lupin gets USFDA nod for Emtricitabine & Tenofovir DisoproxilFumarate Tablets
7 Jun 2021 , 2:18PM
The product will be manufacture at Lupin's facility in Nagpur, India
-
Lupin enters digital healthcare space
3 Jun 2021 , 12:43PM
Lupin steps into the digital healthcare space with a focus to provide a digital therapeutics platform for doctors and patients in India
-
Lupin
27 May 2021 , 2:19PM
Lupin: Has announced the achievement of key milestones for its MEK inhibitor compound (LNP3794) that is planned for development by Boehringer Ingelheim in combination as potential targeted therapy for patients with difficult-to-treat cancers. As part of the agreement, Lupin has received payment of USD 50 million from Boehringer Ingelheim for achievement of key milestones. In 2019 Lupin and Boehringer Ingelheim inked a licensing, development and commercialization agreement for Lupin’s novel oncology compound to treat KRAS-driven cancers. The receipt of milestone payment of $50 mn is positive and also this provides visibility on the strong product pipeline.
-
Lupin receives $50 mn from Boehringer Ingelheim
27 May 2021 , 11:50AM
Lupin announces achievement of Key Milestones for its Clinical Stage MEK Inhibitor Compound
-
Lupin
10 May 2021 , 2:56PM
Lupin: has signed a royalty-free, limited, non-exclusive voluntary licensing agreement with Eli Lilly for manufacturing and selling of Eli Lilly’s drug Baricitinib in India. Barcitinib has received permission from Central Drugs Standard Control Organization for restricted emergency use in combination with Remdesivir for the treatment of suspect or laboratory-confirmed COVID-19 in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. Baricitinibs timely and restricted emergency use could be an important life saving treatment for Covid 19 patients and with the surge in Covid cases in India, the demand for Barcitinib is expected to be higher, hence the licensing agreement is positive.
-
Cipla, Lupin, Sun Pharma, Dr Reddys
3 May 2021 , 10:20AM
The companies had earlier subscribed to a 20% partnership in ABCD Technologies LLP and pursuant to inclusion of 9 new partners in the company the share of the partnership now stands revised to 6.45% with a corresponding share of profits as well.
-
Lupin
28 Apr 2021 , 11:45AM
Lupin: has settled a lawsuit in the US for cancer drug Evomela with Ligand. Earlier ligand has claimed that Lupin’s purposed generic version of Evomela infringes two patents for Evomela. As per the settlement, Luoin won’t sell its version of Evomela until such date permitted by the settlement agreement.
-
Lupin
22 Apr 2021 , 11:46AM
Lupin: The company has incorporated a wholly owned subsidiary company in the US under the name Lupin Oncology Inc. This wholly owned subsidiary will be engaged in development/co-development and commercialization of multiple oncology Products globally and will also be pursuing partners, financial sponsors
-
Cadila, Lupin, Sun Pharma, Torrent Pharma
26 Mar 2021 , 10:25AM
Each of the companies either directly or through subsidiary companies have subscribed to partnership interest in ABCD Technologies LLP , which is a recently incorporated entity and has not commenced any business activity. The consideration for the said partnership is Rs 40 crore by each of the companies for acquisition of a 20% stake each in ABCD Technologies LLP, which would be renamed as IndoHealth Services LLP. The objective of the partnership is to facilitate, enable and promote efficiency and Good Distribution Practices including digitizing healthcare infrastructure in India, inter alia, in support of the National Digital Health Mission of Government of India. Neutral read thru
-
Lupin
10 Mar 2021 , 2:55PM
Lupin: Has launched the generic version of Alinia tablets strength – 500 mg in the US, which are used to treat diarrhea caused by Giardia lamblia or Cryptosporidium parvum in patients 12 years of age and older. The reference listed drug – Alinia has reported US sales of $ 56 mn as per IQVIA MAT January 2021. The launch is positive as it could help grow the US topline as well as also widen the product offerings.
-
Lupin launches authorized generic version of Alinia
10 Mar 2021 , 2:53PM
Lupin launches generic version of Alinia tablets strength – 500 mg in the US
-
Lupin's canada arm announces partnership with Endoceutics
9 Mar 2021 , 10:57AM
Lupin's canada arm announces partnership with Endoceutics for commercialisation of ‘Intrarosa’
-
Lupin launches penicillamine tablets USP
2 Mar 2021 , 3:28PM
Lupin gets USFDA nod to launch Penicillamine Tablets USP, 250 mg
-
Lupin
19 Feb 2021 , 5:02PM
Lupin: Gets final approval from the USFDA for Droxidopa Capsules, 100 mg, 200 mg and 300 mg. The Droxidopa Capsules are indicated for the treatment of orthostatic dizziness, lightheadedness, in adult patients with symptomatic neurogenic orthostatic hypotension. Droxidopa Capsules reported an estimated annual sales of USD 352 mn in the US as per IQVIA MAT December 2020. The approval is positive as would add to the US sales.
-
Lupin
17 Feb 2021 , 1:50PM
Posaconazole Delayed-Release Tablets, 100 mg after its alliance partner AET Pharma US Inc. got an approval for its ANDA from USFDA. The tablets are indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised. The reference listed Drug Noxafil reported estimated annual sales of $186 mn in the US as per IQVIA MAT December 2020. The approval is positive for Lupin as it would add to US sales.
-
Lupin launches Posaconazole Delayed-Release Tablets
17 Feb 2021 , 12:08PM
Lupin launches Posaconazole delayed-release tablets, used for the treatment of Invasive Aspergillus & Candida infections
-
Lupin receives nod for Tavaborole Topical Solution
9 Feb 2021 , 3:28PM
Lupin receives USFDA approval for Tavaborole topical solution which used to treat toenail infection caused by fungus
-
Lupin Q3FY2021
29 Jan 2021 , 10:03AM
Lupin Q3FY2021: Strong Operating performance and a low tax leads to PAT beat
-
Lupin : Multiple growth levers in action
27 Jan 2021 , 10:38AM
Lupin : Multiple growth levers in action
-
Lupin get nod for Sevelamer Carbonate Tablets
25 Jan 2021 , 12:37PM
Sevelamer Carbonate Tablets, used for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis
-
Lupin
7 Jan 2021 , 3:44PM
Lupin: Gets tentative approval from the USFDA for its Empagliflozin and Metformin Hydrochloride Extended Release Tablets with strengths - 5 mg/1000 mg, 10 mg/1000 mg, 12.5 mg/1000 mg, and 25 rng/1000 mg. The tablets are indicated as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus. The reference listed drug – Synjardy XR has an estimated annual sales of $357 mn in the US as per IQVIA MAT November 2020. The tentative approval is positive as it points at a healthy growth potential for the US business of the company
-
Lupin gets tentative nod for Extended Release tablets from USFDA
7 Jan 2021 , 3:38PM
Lupin receives tentative approval for Empagliflozin and Metformin Hydrochloride ER Tablets
-
Lupin gets USFDA nod to market generic version of Sulfamethoxazole and Trimethoprim
7 Jan 2021 , 10:14AM
Lupin receives approval for Sulfamethoxazole and Trimethoprim Oral Suspension USP
-
Lupin
7 Jan 2021 , 10:01AM
Received approval from the USFDA for Sulfamethoxazole and Trimethoprim Oral Suspension USP, 200 mg/40 mg per 5 ml. The drug is indicated for treatment and prevention of a wide variety of bacterial infections (such as middle ear, urine, respiratory, and intestinal infections), and certain type of pneumonia (pneumocystis-type). Reference Listed Drug – Bactrim m) had estimated annual sales of approximately USD 19 million in the US as per IQVIA MAT September 2020. The approval is positive as it would help grow the US sales.
-
Lupin
6 Jan 2021 , 10:54AM
As per media news, The USFDA has issued form 483 to Lupin’s Somerset Facility (New Jersey, US) with around 12 observations. The facility was inspected between 10th September 2020 to November 2020. The plant was earlier classified as OAI (Official Action indicated) by the USFD and was up for re-inspection. The receipt of form 483 is sentimentally negative.
-
Lupin launches osteoarthritis drug
28 Dec 2020 , 5:16PM
reference listed drug Vivlodex reported annual sales of ~ $ 11 million in the US
-
Lupin gets USFDA nod for toenail drug
28 Dec 2020 , 2:11PM
The reference listed drug – Jublia has estimated annual sales of $222.9 million in the US
-
Lupin gets USFDA nod for toenail drug
28 Dec 2020 , 2:08PM
The reference listed drug – Jublia has estimated annual sales of $222.9 million in the US
-
Lupin
22 Dec 2020 , 9:48AM
USFDA approval for Rufinamide Oral Suspension, 40 mg/ml, which is a generic equivalent of Banzel Oral Suspension. The drug is indicated adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in pediatric patients 1 year of age and older, and in adults. Banzel had an estimated annual sales of USD 124.5 million in the US as per IQVIA MAT September 2020. The approval is positive as it would add to the US sales.
-
Lupin gets approval for Colesevelam Hydrochloride Tablets
21 Dec 2020 , 3:16PM
Lupin received approval for its Colesevelam Hydrochloride Tablets, 625 mg, from the USFDA
-
Lupin
21 Dec 2020 , 9:53AM
Lupin: Gets approval for its Colesevelam Hydrochloride Tablets, 625 mg from the USFDA. The medicine is a generic equivalent of Welchol Tablets. The medicine is indicated to reduce the Cholesterol levels (LDL – C). The generic equivalent tablet has reported an annual sale of approximately USD 159 million in the US as per IQVIA MAT September 2020. The approval is positive as it would add to the US sales
-
Lupin
16 Dec 2020 , 3:11PM
Has announced that it has amicably settled a dispute with the sellers in the Gavis / Novel transaction and to the satisfaction of all involved parties. Back in March 2016 Lupin had completed the acquisition of the US based Gavis Pharmaceuticals LLC and Novel Laboratories, which had strengthened its presence in the Us generic markets and had complemented its portfolio in the dermatology business. The settlement of dispute is positive as it would remove the overhang
-
Lupin receives approval for Penicillamine Tablets USP
1 Dec 2020 , 2:31PM
Lupin gets USFDA nod for Penicillamine Tablets, indicates in the treatment of Wilson’s disease, Cystinuria, and in patients with severe, active x who have failed to respond to an adequate trial of conventional therapy
-
Lupin
25 Nov 2020 , 1:43PM
Lupin: Alliance partner - Concord Biotech Limited has received an approval from the USFDA for Tacrolimus Capsules USP – Strength 0.5 mg, 1 mg, and 5 mg. Consequently, Lupin has launched the medicine in the US. The capsules are indicated for prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant, liver transplant, and heart transplant, and in pediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants. Tacrolimus Capsules had an annual sales of approximately USD 303 million in the U.S as per IQVIA MAT September 2020. The launch is positive as it would aid the growth in the US sales.
-
Lupin launches Tacrolimus Capsules USP
25 Nov 2020 , 1:42PM
Lupin launches immunosuppressive drug, Tacrolimus capsule in the US market
-
Lupin
17 Nov 2020 , 9:44AM
As per media news, the USFDA has accepted Lupin’s Supplemental New Drug Application for Solosec, which is a drug indicated for the treatment of trichomoniasis in adults and adolescents. The FDA has assigned a target date of June 30, 2021. If approved for trichomoniasis, Solosec could be the only single-dose oral prescription treatment for the infection.
-
Lupin's alliance partner concord receives USFDA approval for Tacrolimus Capsules USP
12 Nov 2020 , 3:37PM
Tacrolimus Capsules USP indicates for the prophylaxis of organ rejection in adult and pediatric patients
-
Lupin Q2FY2021: Weaker quarter
5 Nov 2020 , 11:30AM
Lupin Q2FY2021: Weaker quarter; higher tax rate leads to PAT decline
-
Lupin
6 Oct 2020 , 1:44PM
Lupin: Gets USFDA approval for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg for the US markets. The medicine is are indicated for the treatment of patients with relapsing forms of multiple sclerosis. Reference listed drug – Tecfidera had annual sales of approx. $ 3788 mn in the US as of June 2020 as per IQVIA MAT. Lupin is expected to launch the product shortly. The Approval is positive as it would fuel the US revenues.
-
Lupin receives approval for Dimethyl Fumarate Delayed-Release Capsules
6 Oct 2020 , 12:43PM
Lupin gets USFDA nod for Dimethyl Fumarate delayed-release capsules, used to treat relapsing multiple Sclerosis
-
Lupin launches Lapatinib tablets
1 Oct 2020 , 10:00AM
Lupin launches generic metastatic breast cancer drug in US
-
Lupin
28 Sep 2020 , 3:37PM
Launches Fosaprepitant for Injection, 150 mg Single-Dose Vial. The drug is indicated for treatment of Acute and delayed nausea and vomiting associated with moderate and high emetogenic cancer chemotherapy (MEC). The reference listed drug Emend – has an annual sales of $136 mn in the US on MAT July 2020. Also the company has launched Atorvastatin Calcium Tablets USP, 10 mg, 20 mg, 40 mg, and 80 mg. The tablets are indicated to lower cholesterol in blood for adults and children over 10 years of age and also is indicated to lower the risk of heart attack and stroke. The reference listed drug Liptor reported US sales of $559 mn as of July 2020 MAT. The launch is positive and would result in higher topline in the US business.
-
Lupin launches Atorvastatin calcium tablets USP
28 Sep 2020 , 1:37PM
Lupin launches Atorvastatin calcium tablets, used to lower cholesterol in blood for adults and children above 10 yrs
-
Lupin
22 Sep 2020 , 5:12PM
Gets USFDA approval for Divalproex Sodium Extended-Release (ER) Tablets USP, 250 mg and 500 mg. The drug is indicated for treatment of manic or mixed episodes associated with bipolar disorder, seizures and Prophylaxis of migraine headaches. The reference Listed drug – Depakote ER has annual sales of USD 130 mn in US as per QVIA MAT July 2020. The approval is positive as it would enable grow the company’s US revenues.
-
Lupin gets USFDA approval for Divalproex tablets
22 Sep 2020 , 3:43PM
Lupin launches Divalproex sodium extended-release tablets, used for treatment of bipolar disorder
-
Lupin hit 52-week high
18 Sep 2020 , 10:32AM
Lupin rises by 9% to Rs. 1,110 in the current market
-
Cipla, Lupin
18 Sep 2020 , 9:59AM
As per media reports, Perrigo Company plc announced a voluntary U.S. nationwide recall of albuterol sulfate inhalation aerosol to the retail level. The drug has US market size of around ~$850-900mn. Cipla and Lupin are the closest competitors to Perrigo in the albuterol sulphate market and hence are likely to be benefit from this
-
Lupin
3 Sep 2020 , 12:17PM
Launches Leflunomide Tablets USP, 10 mg and 20 mg, after it received an approval from the USFDA. The drug is a generic equivalent of Arava tablets of Sanofi-Aventis U.S. and is indicated for the treatment of adults with active rheumatoid arthritis. Arava tablets had an annual sales of ~ $42 million in the US MAT June 2020. The launch is positive as this would help improve the US business.
-
Lupin launches Leflunomide tablets USP
2 Sep 2020 , 4:04PM
Lupin launches anti-rheumatic drug, Leflunomide tablet in the US market
-
Lupin, Mylan launch Nepexto, biosimilar Etanercept in Germany
26 Aug 2020 , 3:25PM
Lupin, Mylan launch Nepexto, biosimilar etanercept, in the German market
-
Lupin receives approval for Generic Albuterol Sulphate MDI
25 Aug 2020 , 10:22AM
Lupin gets approval from the US drug regulator for its Albuterol Sulfate inhalation aerosol
-
Lupin
25 Aug 2020 , 9:43AM
Lupin gets approval for generic Albuterol Sulphate MDI Albuterol Sulfate Inhalation Aerosol, 90 mcg (base)/actuationm indicated for the treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms; total Albuterol Sulfate Inhalation Aerosol market had U.S. sales of approximately US$2.9 bn – positive for Lupin
-
Lupin
21 Aug 2020 , 9:19AM
ForDoz Pharma partners with Lupin on development of two complex injectable products in advanced development stage at ForDoz, in US and its territories; the products are in the Oncology and Anti-infective therapeutic areas which when approved, will provide affordable alternatives to patients and healthcare professionals – positive read thru as strategic addition to its Complex Injectables pipeline would bolster its Institutional business offerings
-
Lupin
20 Aug 2020 , 11:01AM
Lupin: Stock update: Uncertainties yet to subside
-
Lupin
17 Aug 2020 , 9:58AM
Plans to submit a supplemental New Drug Application for Solosec to the USFDA for the treatment of trichomoniasis later this year. The company announced results from its pivotal Phase 3 clinical trial to assess efficacy and safety of single-dose Solosec (secnidazole) 2g oral granules in female patients with trichomoniasis in the US markets. The trial results showed a clinically and statistically significant response rate, or microbiological cure, in patients. Positive for Lupin, If the drug gets final approval as it would help to grow the US business.
-
Lupin
10 Aug 2020 , 11:59AM
Lupin: Q1FY2021 Result Update - Weak quarter; uncertainties yet to subside
-
Lupin
10 Aug 2020 , 10:08AM
Is recalling 11,688 bottles of Lisinopril tablets USP, 10 mg, which is used to treat high blood pressure, in the US market. The recall is due to presence of foreign tablets in specific number of bottles. Lisinopril tablets USP, (20 mg) were found in a 1,000 count bottle of Lisinopril Tablets USP (10 mg). The USFDA has classified this has a type II recall and hence this is unlikely to have any material impact on the financial performance of the company
-
Lupin
7 Aug 2020 , 12:12PM
Wholly-owned subsidiary Lupin Inc. has entered into an agreement with ForDoz Pharma Corp for granting Lupin the exclusive rights to market and distribute 2 complex injectable assets, which are in advanced stages of development in US and its territories. The assets are in the Oncology and Anti-infective therapeutic areas and when approved would provide affordable alternatives to patients and healthcare professionals. The assets will be made at the Fordoz’s plant in the US and Fordoz would be be responsible for the development, and obtaining the necessary regulatory approvals while Lupin would be responsible for marketing and distribution. If the assets are approved by the regulator, The agreement is positive for Lupin as it would offer new growth opportunities in the US.
-
Lupin
7 Aug 2020 , 11:20AM
Lupin Q1FY2021: Weaker than expected performance
-
Lupin
6 Aug 2020 , 5:06PM
In alliance with concord Biotech has announced the receipt of approval from USFDA for Mycophenolate Mofetil Tablets USP - 500 mg, to market a generic version of Cell Cept Tablets of Roche. Mycophenolate Mofetil Tablets are indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. The reference Listed drug – cellcept had annual sales in the US to the tune of $ 96 mn as per IQVIA – MAT March 2020. The approval is positive as it could add to the topline growth of the US business
-
Lupin's alliance partner gets USFDA nod to market CellCept Tablets
6 Aug 2020 , 3:32PM
Lupin's alliance partner concord receives USFDA approval for Mycophenolate Mofetil Tablets USP
-
Lupin
5 Aug 2020 , 12:32PM
Lupin: Has launched Favipiravir in India under the brand name “Covihalt” for the treatment of mild to moderate COVID-19. Favipiravir has received authorization from the Drug Controller General of India for emergency use. Covihalt’s dosage strength has been developed keeping in mind convenience of administration. It is available as 200 mg tablets in the form of a strip of 10 tablets, and priced at Rs. 49 per tablet and is competitively priced. Given the increase in Covid cases in India, the demand for the medicine could surge and aid topline growth.
-
Lupin launches Favipiravir Drug Covihalt for treatment of mild to moderate COVID-19
5 Aug 2020 , 11:29AM
Favipiravir in India under the brand name Covihalt for the treatment of mild to moderate COVID-19
-
Lupin receives tentative USFDA nod for Empagliflozin tablets
4 Aug 2020 , 2:46PM
Empagliflozin Tablets indicates as an adjunct to diet and exercise to improve glycemic control in adults
-
Lupin
3 Aug 2020 , 11:47AM
As per media news, Lupin is recalling 35,928 bottles of a generic antibiotic drug – Cefdinir in the US market following unfavourable result in retention samples. The lot has been manufactured at Lupin's Mandideep (Madhya Pradesh) manufacturing facility. The recall is for a specific lot and is due to Out of Specification results. The recall is classified as a Class – II recall, Voluntary one and hence is unlikely to have a material impact.
-
Lupin gets tentative nod from USFDA
24 Jul 2020 , 10:38AM
Lupin receives tentative approval for Empagliflozin and Linagliptin Tablets
-
Lupin
24 Jul 2020 , 9:41AM
Gets tentative approval from the U.S. FDA for its Empagliflozin and Linagliptin tablet. The approval is to market a generic version of Glyxambi tablets of Boehringer Ingelheim Pharma. The drug is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. The approval is positive as it would help improve the US business of the company
-
Lupin
15 Jul 2020 , 10:07AM
As per media reports, Lupin has shut one of its manufacturing plants in Gujarat as around 17 employees at the site tested positive for COVID-19. The pant manufactures tuberculosis drugs and was shut on 12 July 2020.
-
Lupin
8 Jul 2020 , 11:58AM
Subsidiary company Lupin Pharmaceuticals Inc. is voluntarily recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg in the US. The recall is on the back of additional analysis by USFDA that revealed certain tested batches which were above the Acceptable Daily Intake Limit for the impurity Nitrosodimethylamine (NDMA). Company has not received any reports of adverse events related to this recall. Lupin has stated that it expect to re-introduce the updated Metformin Hydrochloride Extended-Release Tablet in the U.S. in the current quarter.
-
Lupin voluntarily recalls Metformin Hydrochloride 500 mg-1g in US
8 Jul 2020 , 10:17AM
Lupin voluntarily recalls its Metformin Hydrochloride Extended-Release tablets USP, 500 mg & 1,000 mg products in the US
-
Lupin
22 Jun 2020 , 12:43PM
The company is voluntarily recalling 4,224 bottles of a product – Lisinopril, in the US. The medicine is used to treat high blood pressure conditions. This is a class II recall on account of a product mix up where Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle. Being a class II recall, it is unlikely to have any material impact on the performance of the company.
-
Lupin
15 Jun 2020 , 12:22PM
Plans to approach the USFDA for re-inspection of their facilities in Goa, Pithampur and Somerset (US). The Goa and Pithampur unit 2 is under USFDA Warning letter since November 2017, while the Somerset plant is under OAI. The management expects the Goa plant and then the Pithampur plant to be ready for inspection over the next couple of months and expects Somerset to be ready before Goa. The resolution of the regulatory hurdles is critical and would be an overhang on the stock until fully resolved. We have a Hold recommendation on the stock.
-
Lupin
12 Jun 2020 , 11:35AM
Got approval from the USFDA for Albendazole Tablets USP, 200 mg. The medicine is an generic equivalent of Albenza Tablets of Impax Laboratories Inc. The drug is indicated for the treatment of Parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm and also for Cystic hydatid disease of the liver, lung, and peritoneum. The generic equivalent had an annual sales of USD 34 Mn MAT as per IQVIA as on April 2020. Positive as this would help improve the US business.
-
Lupin receives approval for Albendazole Tablets USP
12 Jun 2020 , 10:05AM
Pharma major announces that it has receive approval for its Albendazole Tablets USP
-
Lupin
11 Jun 2020 , 1:03PM
As per media news, the company is voluntarily recalling one lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg. USFDA analysis revealed that this lot had acceptable limits of NDMA, which is a carcinogenic substance. As the recall is voluntary one and is only for a specific lot, it is unlikely to have any material impact on the performance of Lupin.
-
Lupin
10 Jun 2020 , 10:08AM
US subsidiary company – Lupin Pharmaceuticals Inc signs marketing pact with Ceek womens health a leading company in the gynaecological care. As per the agreement lupin would market Ceek’s products alongside its women's health flagship product, Solosec (secnidazole) 2g oral granules, indicated for the treatment of bacterial vaginosis (BV). This is positive for Lupin as it would widen the product offerings in the US
-
USFDA grants Mexiletine Orphan drug designation
8 Jun 2020 , 10:47AM
USFDA grants ODD to mexiletine hydrochloride for the treatment of myotonic disorders
-
USFDA grants Mexiletine Orphan drug designation
8 Jun 2020 , 10:46AM
USFDA grants ODD to mexiletine hydrochloride for the treatment of myotonic disorders
-
Lupin
5 Jun 2020 , 9:12AM
European Commission has granted marketing authorization to Lupin and Mylan for Nepexto, a biosimilar to Enbrel (etanercept). The drug is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis. The authorization follows the adoption of a positive opinion by the Committee for Medicinal Products for Human Use in March this year and the authorization applies to all member countries of the European Nation. As per IQVIA, Enbrel had global sales of approximately $ 9.6 bn for the 12 months ending December 2019. Positive as this would substantially boost topline.
-
Lupin
3 Jun 2020 , 11:47AM
Lupin has entered in to distribution agreement with three companies in the EU region – Exeltis Healthcare (Spain and Portugal), Cresco Pharma B.V (Netherlands) and Macure Pharma ApS (Nordic Countries), for its orphan drug NaMuscla (mexiletin). The drug is indicated for symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. Under the agreement the companies would commercialise the drug in EU region, while Lupin would continue to commercialize the drug in Germany and UK and would launch the product in Australia and France later this year. The move is positive as this would enable the company to address the needs of patients suffering from NDM in EU and Australia and thus aid revenue growth.
-
Lupin signs distribution agreement in Key EU Territories for Orphan Drug NaMuscla
3 Jun 2020 , 11:10AM
Lupin global signs cs in key EU territories for orphan drug Namuscla
-
Lupin receives approval for Meloxicam capsules
3 Jun 2020 , 9:44AM
The drug is a generic equivalent of Vivlodex Capsules manufactured by Zyla Life Sciences US
-
Lupin
3 Jun 2020 , 9:18AM
Gets USFDA approval for Meloxicam Capsules, 5 mg and 10 mg. The drug is a generic equivalent of Vivlodex Capsules manufactured by Zyla Life Sciences US. The drug is indicated for indicated for management of osteoarthritis pain. The generic equivalent had an annual sale of approximately USD 14 million in the U.S as per IQVIA MAT. This is Positive as approval would help the improve the US business.
-
Lupin
1 Jun 2020 , 12:21PM
Lupin Limited: Q4FY2020 Result Update – Regulatory Overhang Stays
-
Lupin
29 May 2020 , 10:00AM
Lupin Q4FY2020: Weak operating performance; low tax & high other income leads to PAT beat
-
Lupin
29 May 2020 , 9:51AM
As per media reports, the company gets USFDA approval for azithromycin tablets. The medicine is an antibiotic and is used to treat bacterial infections. Positive as this would help improving the US business.
-
Lupin
22 May 2020 , 2:34PM
Gets USFDA approval for Trientine Hydrochloride Capsules USP - 250 mg. The medicine is a generic equivalent of Syprine Capsules of Bausch Health US. The drug is indicated for treatment of patients with Wilson's disease who are intolerant of penicillamine. The product would be manufactured at Lupin’s Nagpur (unit 1) facility. The drug has reported an annual US sales of USD 86 mn, as per IQVIA MAT March 2020. Positive as this would add to the US business growth
-
Lupin receives approval for Trientine Hydrochloride Capsules USP
22 May 2020 , 2:00PM
Lupin gets USFDA nod for Trientine Hydrochloride Capsules USP - 250 mg
-
Lupin launches authorized generic version of Apriso
19 May 2020 , 11:42AM
Launch of authorized generic version of Bausch Health’s Apriso
-
Lupin
14 May 2020 , 10:19AM
Gets Establishment Inspection Report (EIR) from the USFDA for its Vizag unit, inspected between January 13 to January 17, 2020. The unit manufactures API (Active Pharmaceutical Ingredients). This is positive as the receipt of the EIR indicates successful closure of the inspection.
-
Lupin's Vizag API facility receives EIR from USFDA
14 May 2020 , 10:06AM
Lupin's Vizag API facility receives establishment inspection report from USFDA
-
Lupin
11 May 2020 , 10:44AM
The UK’s regulator MHRA (Medicines and Healthcare products Regulatory Agency) has successfully closed the inspection process at the company’s manufacturing plant at Pithampur – unit I,II and III. The inspection was conducted in January 2020. Successful closure of the inspection is positive.
-
Lupin Pithampur plant completes successful UK MHRA
11 May 2020 , 10:04AM
Lupin's pithampur facilities complete successful UK MHRA inspection
-
Lupin
5 May 2020 , 9:11AM
Has announced a positive top-line result from its phase 3 clinical trial to assess efficacy and safety of single dose Solosec (Secnidazole) 2g oral granules. The drug is used to treat Trichomoniasis. Based on the data, the company plans to file Supplemental New Drug Application (sNDA) with the USFDA in the 2H2020. Trichomoniasis impacts 3 to 5 mn people in the US, hence points at substantial size of opportunity for the US business; Positive
-
Lupin
5 May 2020 , 9:10AM
Has announced a positive top-line result from its phase 3 clinical trial to assess efficacy and safety of single dose Solosec (Secnidazole) 2g oral granules. The drug is used to treat Trichomoniasis. Based on the data, the company plans to file Supplemental New Drug Application (sNDA) with the USFDA in the 2H2020. Trichomoniasis impacts 3 to 5 mn people in the US, hence points at substantial size of opportunity for the US business; Positive
-
Lupin's Pithampur Unit-1 facility receives EIR from USFDA
30 Apr 2020 , 9:45AM
USFDA issues Establishment Inspection Report for Lupin Global's Pithampur Unit-1
-
Lupin gets tentative nod for Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 mL
29 Apr 2020 , 2:31PM
Drug indicates treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysem
-
Lupin
29 Apr 2020 , 2:17PM
The company has received a tentative approval from the USFDA to market Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 mL, Unit-dose Vials. The drug is indicated for treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The drug has an annual sales of USD 489 mn in the US as per IQVIA MAT Feb 2020. Positive read thru as this would improve the US business.
-
Lupin
23 Apr 2020 , 9:51AM
As per media news, Solosec oral granules have received preferred coverage effective immediately on the Express Scripts National Preferred, Flex, and Basic commercial formularies. Sentimentally Positive
-
Lupin's Mandideep Unit II facility receives EIR from USFDA
15 Apr 2020 , 9:48AM
Lupin's Mandideep Unit II gets establishment inspection report from USFDA
-
Lupin contributes Rs. 21 crore towards COVID-19 relief efforts
13 Apr 2020 , 9:44AM
Pharma major announces contribution of Rs. 21 crore for relief efforts directed towards mitigating the COVID-19 crisis
-
Lupin
8 Apr 2020 , 9:38AM
Lupin gets USFDA approval for Drospirenone, Ethinyl Estradiol tablets, which is combination birth control pill. Positive as this would widen the company’s product offering in the US
-
Lupin
7 Apr 2020 , 12:39PM
Launches Mycophenolic Acid Delayed-Release Tablets USP - 180 mg and 360 mg. Lupin’s partner Concord Biotech Limited (Concord) had received an approval from the USFDA. The drug is indicated for of Prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. This is also Used in combination with cyclosporine and corticosteroids. The drig had an annula sales of $156 mn in US as per IQVIA MAT – February 2020. Positive
-
Lupin launches Mycophenolic Acid Delayed-Release Tablets USP
7 Apr 2020 , 9:34AM
Pharma major announces the launch of Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg
-
Lupin's Aurangabad facility receives EIR from USFDA
3 Apr 2020 , 9:39AM
Pharma major gets EIR from USFDA for Aurangabad facility
-
Lupin
30 Mar 2020 , 12:14PM
Lupin announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Nepexto, a biosimilar to Enbrel (etanercept), for all indications of the reference product including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis. The positive opinion will now be considered by the European Commission (EC). Once approved, the EC would grant a central marketing authorization for member countries of the EU. The authorization is likely to come in May 2020. This would be positive for Lupin as it would enable it to market the drug in the EU region.
-
Lupin's inhalation research center, Florida gets EIR from USFDA
30 Mar 2020 , 10:57AM
Lupin gets EIR from the USFDA for its inhalation Research Center located at Coral Springs, Florida
-
Lupin appoints Ramesh Swaminathan as CFO and head corporate affairs
27 Mar 2020 , 2:28PM
Appointment of Ramesh Swaminathan as chief financial officer and head corporate affairs
-
Lupin
23 Mar 2020 , 11:47AM
launched Betamethasone Dipropionate Ointment USP (Augmented), 0.05%, to be manufactured at Pithampur (Unit Ill) facility, India. Ointment is the generic equivalent of Diprolene Ointmentof Merck Sharp and Dohme Corp. It is a corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid -responsive dermatoses in patients 13 years of age and older. Diprolene (Reference Listed drug) had an annual sales of approximately USD 21 million in US as per (IQVIA MAT January 2020). Positive
-
Lupin introduces generic version of Vimovo tablets
6 Mar 2020 , 12:34PM
Lupin launches authorized generic version of Vimovo
-
Lupin
6 Mar 2020 , 10:58AM
The company announced the launch of the authorized generic tablet for Horizon Therapeutics PLC's Vimovo delayed release tablets in the U.S. The product is a combination of naproxen, and esomeprazole magnesium, a proton pump inhibitor (PPI) indicated in adult and adolescent patients 12 years of age and older requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk of developing naproxen-associated gastric ulcers. The tablet had annual sales of approximately USD 400 million in the U.S. as of January 2020 - IQVIA MAT. Positive as this would add to the topline.
-
Lupin
25 Feb 2020 , 1:00PM
As per media news, USFDA has approved Perrigo's ANDA for generic Albuterol Sulfate - inhalation aerosol, the first AB-rated generic version of ProAir. Lupin too had filed for the drug and would not get an approval as the company has received a complete response letter from the USFDA, consequently new approvals are withheld. Negative
-
Lupin
17 Feb 2020 , 12:16PM
Has launched Moxifloxacin Ophthalmic Solution USP, 0.5%. The drug is the AT2 rated generice equivalent of Moxeza of Novartis. The drug is indicated for treatment of bacterial conjunctivitis caused by susceptible strains of certain organisms. The drug has annual sales of approximately USD 10 million in the U.S. as per IQVIA MAT December 2019. Given the comparatively small size of the market for the drug, it is unlikely to materially boost the topline.
-
USFDA completes inspection of Lupin's Aurangabad facility with Zero observation
17 Feb 2020 , 10:41AM
Aurangabad facility inspection concludes without any observation
-
Lupin
13 Feb 2020 , 11:41AM
Lupin: Q3FY2020 Result Update - Regulatory hurdles point to tough revival
-
USFDA completes inspection of Lupin's Pithampur (Unit-I) facility
12 Feb 2020 , 3:31PM
The inspection for the Pithampur (Unit-I) facility closes with two 483 observations
-
Lupin
7 Feb 2020 , 11:44AM
Lupin Q3FY2020: Weak performance
-
Lupin
6 Feb 2020 , 11:01AM
The company has received an approval from the USFDA for Leflunomide Tablets USP, 10 mg and 20 mg, to market a generic equivalent of Arava Tablets of Sanofi Aventis. The product would be manufactured at Lupin's Pithampur (Unit 1) facility. Leflunomide Tablets are indicated for the treatment of adults with active rheumatoid arthritis. Leflunomide Tablets USP had annual sales of approximately USD 44 million in the U.S as IQVIA MAT December 2019. Positive as this would add to Lupins topline
-
Lupin
27 Jan 2020 , 11:09AM
The successful completion of the inspection carried out by the UK Medicines and Healthcare products Regulatory Agency, the regulatory agency of the United Kingdom at its three manufacturing units in Pithampur (India). The inspection for the three units at Pithampur closed with no critical observation and one major observation. The nature of one major observation received is not known and could have an adverse impact on the stock. We have a reduce recommendation.
-
Lupin
20 Jan 2020 , 10:21AM
The company’s Vizag API facility was inspected by the US-FDA between 13 Jan 2020 to 17 Jan 2020. The inspection closed with five observations. The nature of observations is not known. Negative read thru
-
Lupin
13 Jan 2020 , 2:11PM
The company gets 2 observations from USFDA for Nagpur facility – negative read through for the stock
-
Lupin falls after USFDA observation
13 Jan 2020 , 11:45AM
USFDA classifies the inspection of Lupin's Tarapur facility as OAI
-
Lupin Ankleshwar facility bags Par Excellence Award
13 Jan 2020 , 10:21AM
Lupin's Ankleshwar facility wins par excellence award at 33rd National Convention on quality concept
-
Lupin
10 Jan 2020 , 10:41AM
As per media reports, the company received US FDA approval for Famotidine, a drug used to decrease stomach acid production. Positive read thru
-
Lupin's Ankleshwar facility wins gold award from American society
10 Jan 2020 , 10:29AM
Pharma major received gold award at the 9th Annual Conference on Quality Management
-
Lupin receives approval for Betamethasone Dipropionate Ointment USP
20 Dec 2019 , 3:10PM
Pharma major gets USFDA nod to market a generic equivalent of Diprolene Ointment
-
Lupin
20 Dec 2019 , 3:04PM
Receives USFDA approval for Betamethasone Dipropionate Ointment USP (Augmented), 0.05%. This is a generic equivalent of Diprolene Ointment of Merck Sharp and Dohme Corp. The drug would be manufactured at Lupin’s Pithampur plant (unit 3) and is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older. As of September 2019 IQVIA MAT data the drug had an annual sales of approximately USD 22 mn. Positive read thru
-
Lupin
20 Dec 2019 , 1:11PM
In alliance with Concord Biotech receives USFDA approval for Mycophenolic Acid delayed release tablets, which is a generic version of Myfortic delayed release tablets of Novartis – Positive read thru for Lupin
-
Lupin completes divestment in Kyowa to Unison
17 Dec 2019 , 12:05PM
Lupin announces completion of Kyowa divestiture to Unison
-
Lupin launches Hydrocortisone Valerate Cream
22 Nov 2019 , 3:22PM
Lupin's Hydrocortisone Valerate Cream is the generic equivalent of Westcort Cream of Sun Pharmaceutical Industries Inc
-
Lupin launches Hydrocortisone Valerate Cream
22 Nov 2019 , 3:20PM
Lupin's Hydrocortisone Valerate Cream is the generic equivalent of Westcort Cream of Sun Pharmaceutical Industries Inc
-
Lupin launches Adhero to support treatment of Respiratory Disease
22 Nov 2019 , 2:05PM
Lupin launches Adhero to support treatment of Respiratory Disease
-
Lupin
20 Nov 2019 , 11:52AM
Announced the launch of Potassium Chloride (KCI) for Oral Solution USP, 20 mEq, having received an approval from the US-FDA. The drug is the generic equivalent of Pharma Research Software Solution, LLC's Potassium Chloride for Oral Solution USP, 20 mEq, and is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. Potassium Chlorise had an annual sales of approximately USD 90 mn in the US. The news has come before the close of market hours yesterday. Positive read thru
-
Lupin
13 Nov 2019 , 10:45AM
Entered into a definitive agreement for the sale of its entire stake in its Japanese subsidiary Kyowa Pharmaceutical Industry Co., Ltd. (‘Kyowa’) to Unison Capital Partners IV, LPS and Unison Capital Partners IV (F). L.P. Under the terms of the agreement, Lupin’s subsidiary Nanomi B.V. will divest its entire stake (99.82%) in Kyowa to Unison’s entity Plutus Ltd. for an enterprise value of JPY 57,361 million (Rs 3702.4 cr). This would generate a post tax cash flow of Rs 2103.9 cr. This is likely to strengthen the company’s balance sheet position as the proceeds are likely to be utilised to repay debts. Net debt of the Company will stand at Rs 1129 cr compared to Rs 4361.8 cr as on September 30, 2019. The deal done at 2x EV/Sales and 11.5x EV/EBITDA, Kyowa Pharmaceutical contributes 10% of Lupin revenues, the deal will be EPS accretive and also bring down the debts. Postive read-thru
-
Lupin
13 Nov 2019 , 10:25AM
Lupin enters into agreement to divest its stake in Kyowa to Unison
-
Lupin
11 Nov 2019 , 12:23PM
Has received approval for its Zileuton Extended-Release Tablets, 600 mg, from US FDA, to market a generic equivalent of Zyflo CR Extended-Release Tablets, 600 mg, of Chiesi USA, Inc. The medicine is indicated for prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Zileuton Extended-Release Tablets, 600 mg had annual sales of approximately USD 43 million in the U.S Positive read thru
-
Lupin gets USFDA nod for Zileuton Extended-Release Tablets
11 Nov 2019 , 10:25AM
Pharma major gets approval from USFDA to market a generic equivalent of Zyflo CR® Extended-Release Tablets
-
Lupin
7 Nov 2019 , 11:04AM
As per media news, Lupin gets US FDA approval for Zileuton, which is used to prevent and control symptoms such as wheezing and shortness of breath caused by asthma. Positive read thru
-
Lupin
6 Nov 2019 , 3:46PM
Lupin Q2FY2020: Operating performance marginally ahead of estimates, Adjusted PAT beat estimates lead by lower tax
-
Lupin receives sANDA approval from USFDA for Levothyroxine Sodium Tablets USP
1 Nov 2019 , 2:58PM
Pharma major gets ANDA nod from USFDA to market a generic equivalent of LEVOXYL
-
Lupin
1 Nov 2019 , 10:11AM
Lupin: As per media news, Lupin is in advanced talks to sell its Japanese generics subsidiary Kyowa Pharmaceuticals for an enterprise value of $600 million to a local player as it steps up efforts to significantly cut operations in Japan. Pricing pressures in Japan and the recent decline in growth and impending further declines have led to re-evaluate the market and investment. The company has been reviewing its global footprint and the decision to scale down Japan is part of that exercise. The company has already moved a lion’s share of the japense manufacturing plant to its Goa facility. The move is positive as the slow growing Japanese business is a drag on profitability
-
Lupin's Nagpur facility receives EIR from the USFDA
18 Oct 2019 , 2:40PM
Lupin global's Nagpur unit get EIR by USFDA, indicating closure of inspection
-
Lupin
14 Oct 2019 , 10:51AM
Company plans to file Etanercept (Pegfilgrastim) biosimilars in US by Q4FY20 – Sentimentally positive read thru.
-
Lupin receives GMP certificate from PMDA
9 Oct 2019 , 12:40PM
Japan's PMDA issues GMP Certificate to Lupin's Unit II Mandideep facility
-
Lupin launches Mycophenolate Mofetil Capsules USPV
7 Oct 2019 , 10:41AM
Pharma major announces the launch of Mycophenolate Mofetil Capsules
-
Lupin appoints Johnny Mikell as Global Head of Quality
3 Oct 2019 , 12:43PM
Pharma major appoints Johnny Mikell as President and Global Head of Quality
-
Lupin
3 Oct 2019 , 12:14PM
Lupin: USFDA finds repeat violations at Lupin’s multiple manufacturing sites including Mandideep Plant; Repeated failures at multiple sites demonstrate oversight and control over drugs are inadequate. Company should assess global manufacturing operations, indicating longer timelines for resolution – Negative
-
Lupin gets USFDA nod for Extended Phenytoin Sodium Capsules USP
1 Oct 2019 , 3:21PM
Lupin receives USFDA approval for generic equivalent of Dilantin, used for the prevention & treatment of seizures
-
Lupin
1 Oct 2019 , 12:29PM
Japan’s PMDA completed inspection of the company’s Goa facility with no critical or major observations. The company has completed the sale of Japanese arm’s sale of injectables business and related assets to the Neopharma Group – Positive read thru.
-
Lupin launches Sildenafil Tablets USP
30 Sep 2019 , 3:27PM
Pharma major introduces Sildenafil Tablets USP getting nod from USFDA
-
Lupin appoints Jon Stelzmiller as President of US Specialty Business
25 Sep 2019 , 12:13PM
Pharma major appoints Jon Stelzmiller as the President of its US Specialty business
-
Lupin's arm signs Commercial Agreement with Creso Pharma
26 Aug 2019 , 4:07PM
Lupin's subsidiary in South Africa announces Commercial Agreement with Creso Pharma for hemp oil based cannaQIX
-
Lupin launches Fluoxetine Tablets USP
22 Aug 2019 , 3:25PM
Lupin launches Fluoxetine Tablets receives approval from USFDA
-
Lupin divests Kyowa Criticare to Neopharma group
22 Aug 2019 , 11:31AM
Lupin's Japanese arm enters into agreement for sale of injectables business
-
Lupin gets USFDA nod for generic of Westcort cream
16 Aug 2019 , 3:37PM
Lupin receives USFDA approval for Hydrocortisone Valerate Cream
-
Lupin Q1FY2020: Mixed bag performance
7 Aug 2019 , 2:48PM
Lupin Q1 net profit rises by 49.4% to Rs. 303 crore
-
Lupin's Aurangabad facility receives EIR from USFDA
5 Aug 2019 , 10:40AM
Lupin gets EIR from USFDA from USFDA for its Aurangabad facility
-
Lupin's Nagpur facility wins ENR global best project award
22 Jul 2019 , 10:55AM
Pharma major secures ENR global best project award of Merit in the Manufacturing category
-
Lupin launches Imatinib Mesylate Tablets
9 Jul 2019 , 4:03PM
Pharma major introduces lmatinib Mesylate tablets, 100 mg and 400 mg
-
Lupin receives USFDA approval for Phenylephrine & Ketorolac Intraocular Solution
3 Jul 2019 , 2:55PM
Lupin's Phenylephrine and Ketorolac Intraocular Solution, 1%/0.3%, is the generic version of Omidria Intraocular Solution
-
Lupin receives tentative USFDA approval for Mirabegron ER Tablets
28 Jun 2019 , 10:56AM
Lupin's Mirabegron ER Tablets, 25 mg and 50 mg, is a generic version of Myrbetriq Extended Release Tablets
-
Japan’s PMDA completed inspection of its Mandideep facility
6 Jun 2019 , 10:43AM
Lupin: Japan’s PMDA completed inspection of its Mandideep facility with no critical or major observations; inspection was conducted between May 14-19, 20109 – Neutral.
-
USFDA classifies the inspection of Lupin's Goa facility as OAI
27 May 2019 , 10:24AM
Lupin: USFDA classifies inspection of Lupin's Goa facility as OAI (Official Action Indicated (OAI); Negative; USFDA may not approve products filed from this plant until issies resloved. Ongoing operations not affected but new approvals may get delayed.
-
USFDA classifies the inspection of Lupin's Goa facility as OAI
27 May 2019 , 10:20AM
Lupin gets communication from the USFDA classifying the inspection conducted at its Goa facility
-
Lupin launches Budesonide Inhalation Suspension
22 May 2019 , 3:35PM
Lupin global launches Budesonide Inhalation Suspension in the US market
-
USFDA completes inspection of Lupin's Aurangabad facility
16 May 2019 , 10:09AM
Lupin's inspection at the Aurangabad facility closes with three observations
-
Lupin launches Clobazam Tablets
10 May 2019 , 1:02PM
Lupin's Clobazam tablets is the generic version of Lundbeck Pharms, LLts Onfi Tablets, 10 mg and 20 mg
-
Lupin, Aptissen enters into distribution agreement Synolis VAfor Canada
9 May 2019 , 10:42AM
Lupin and Aptissen announce exclusive distribution agreement of Synolis VAfor Canada
-
USFDA classifies the inspection of Lupin's Pithampur facility as OAI
24 Apr 2019 , 10:27AM
USFDA classifies Pithampur facility as OAI
-
Lupin surges on Morgan Stanley upgrades
23 Apr 2019 , 1:07PM
Lupin rises over 4% to Rs. 868.5, after Morgan Stanley upgrades its rating on the stock to overweight
-
Lupin gets USFDA nod for Fluoxetine Tablets
16 Apr 2019 , 2:36PM
Pharma major receives FDA approval for Fluoxetine Tablets USP
-
Lupin launches Testosterone Gel
12 Apr 2019 , 12:23PM
Lupin launch Testosterone Gel, 1.62% for which, USFDA approval was received earlier
-
Lupin receives FDA approval for Testosterone Gel
11 Apr 2019 , 1:00PM
Lupin receives approval for its Testosterone Gel from USFDA to market a generic version of AndroGel
-
Lupin launches Fluoxetine Tablets USP
10 Apr 2019 , 2:27PM
Lupin launches Fluoxetine Tablets USP, 60mg, gets an approval from the USFDA
-
Lupin Bioresearch Centre completes fifth successful USFDA inspection
3 Apr 2019 , 10:42AM
Lupin successful completes the USFDA inspection at its Lupin Bioresearch Centre
-
Lupin gets EIR from USFDA
3 Apr 2019 , 9:45AM
Lupin: Company receives Establishment Inspection Report (EIR) from the USFDA for its Pithampur facility (Unit-3) in Madhya Pradesh; Unit-3 facility is involved in the manufacture of metered dose inhalers (MDIs), dry powder inhalers (DPIs) and topical formulations for the regulated markets – Positive; Company continues to grapple with USFDA at other key sites like Somerset, Mandideep; We have a reduce rating on stock with TP under review.
-
Lupin Pithampur Unit-3 receives EIR from USFDA
2 Apr 2019 , 11:09AM
Lupin Pithampur Unit-III receives establishment inspection report from the USFDA
-
Lupin US facility somerset gets form 483
1 Apr 2019 , 9:59AM
Lupin: Company’s US facility Somerset (in New Jersey) receives form 483 with 6 obs – Negative.
-
Lupin Company recalls 3200 bottles of Testosterone Topical Solutins in US
1 Apr 2019 , 9:19AM
Lupin: Company recalls 3,200 bottles of Testosterone Topical Solution in the US on the back of repetitive complaints of container indicating faulty pump – Negative read thru.
-
Lupin, YL Biologics gets nod to market rheumatoid arthritis drug in Japan
26 Mar 2019 , 1:13PM
Lupin and YL Biologics receives PMDA approval for Etanercept biosimilar in Japan
-
Lupin gets USFDA nod for generic of Viagra tablets
25 Mar 2019 , 12:26PM
Lupin global gets USFDA nod for leading anti-erectile dysfunction drug
-
Lupin launches generic Levothyroxine Sodium Tablets USP
22 Mar 2019 , 12:59PM
Pharma major receives USFDA nod to launch Levothyroxine Sodium Tablets USP
-
Lupin falls after USFDA letter for New Jersey plant
18 Mar 2019 , 1:15PM
Lupin slips over 5% to Rs. 741.35, after USFDA classifies the inspection of its Somerset facility as Official Action Indicated
-
USFDA classifies inspection of Lupin’s arm Novel Labs
18 Mar 2019 , 10:46AM
Lupin: USFDA classifies inspection of Lupin’s arm Novel Labs’ US facility as Official Action Indicated (OAI) – Negative; second OAI within a week; fear of a companywide regulatory issue
-
Lupin gets OAI letter from USFDA for MP plant
14 Mar 2019 , 10:31AM
USFDA classifies the inspection at the Company's Mandideep (Unit 1) facility as OAI
-
Lupin receives FDA approval for Atorvastatin Calcium Tablets USP
8 Mar 2019 , 10:59AM
Pharma major received approval for its Atorvastatin Calcium Tablets
-
Lupin, Natco get FDA nod for Imatinib Mesylate tablets
5 Mar 2019 , 2:19PM
Lupin in alliance with Natco receives FDA approval for Imatinib Mesylate Tablets
-
Lupin gets FDA nod for Azacitidine for Injection
28 Feb 2019 , 3:34PM
Pharma major receives FDA approval for Azacitidine for Injection, 100 mg Single-Dose Vial
-
Lupin launches generic Ranolazine ER Tablets in US
28 Feb 2019 , 11:31AM
Pharma major announces the exclusive launch of its Ranolazine Extended-Release (ER) Tablets
-
Lupin launches Minocycline Hydrochloride ER tablets
26 Feb 2019 , 2:59PM
Pharma major introduces generic Minocycline Hydrochloride ER Tablets USP 55mg
-
Lupin receives USFDA approval for methylprednisolone tablets
25 Feb 2019 , 5:01PM
Pharma major gets USFDA nod to market a generic version of Pharmacia and Upjohn Company's Medrol tablets
-
Lupin launches Clobazam Oral Suspension
15 Feb 2019 , 2:48PM
Pharma major launches Clobazam Oral Suspension, 2.5mg/mL in the US market
-
Lupin launches Tadalafil Tablets USP
12 Feb 2019 , 3:32PM
Pharma major announces the launch of Tadalafil Tablets USP 20 mg
-
Lupin gets USFDA approval for Tadalafil Tablets USP, 20 mg
7 Feb 2019 , 10:39AM
Pharma major receives USFDA nod for Tadalafil Tablets
-
USFDA completes inspection of Lupin's Pithampur Unit 2
28 Jan 2019 , 11:01AM
Lupin: USFDA completed inspection of Lupin’s Pithampur Unit 2 (unit under warning letter) with six observations – sentimentally negative; clarification on nature of observations awaited
-
Lupin gets FDA nod for Levothyroxine Sodium Tablets
22 Jan 2019 , 10:53AM
Lupin receives FDA approval for Levothyroxine Sodium Tablets; used to treat thyroid – Positive; one of the key product approval expected; could contribute ~ $30-40 mn of sales; successful resolution of warning letter issued to two sites will be next trigger to watch for.
-
Lupin voluntarily recalls 55,000 vials
21 Jan 2019 , 12:05PM
Lupin voluntarily recalls 55,000 vials and over 1.6 lakh boxes of anti-bacterial drug Ceftriaxone for injection; manufactured at the company's facility in Mandideep – Negative; ongoing voluntary nationwide recall has been classified as Class-I recall, meaning dangerous or defective products that predictably could cause serious health problems.
-
Lupin gets nod for treatment of Myotonia
8 Jan 2019 , 11:02AM
Orphan Drug NaMuscJa receives European Commission approval for the Treatment of Myotonia in Non-Dystrophic Myotonic Disorders
-
Lupin gets USFDA nod for generic schizophrenia drug
7 Jan 2019 , 3:17PM
Lupin receives FDA approval for Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg & 120 mg
-
Lupin gets USFDA nod for Clobazam Oral Suspension
1 Jan 2019 , 11:58AM
Lupin received USFDA approval for Clobazam Oral Suspension; generic version of Lundbeck Pharma’s Onfi Oral Suspension for treatment of seizures in patients two years of age or older – Positive
-
Lupin partnership with AbbVie for novel oncology drug
24 Dec 2018 , 11:34AM
Lupin partnership with AbbVie for novel oncology drug
-
Lupin gets USFDA nod for Apixaban Tablets
11 Dec 2018 , 9:51AM
Lupin receives tentative US FDA approval for Apixaban Tablets, 2.5 mg and 5 mg.
-
Lupin's Pithampur Unit-3 receives EIR from USFDA
10 Dec 2018 , 2:38PM
Lupin gets EIR report for its Pithampur (Unit 3) facility
-
USFDA issues observations for Lupin global's Mandideep Unit
5 Dec 2018 , 1:46PM
Lupin completes inspections carried out at its Mandideep location
-
Lupin's CFO resigns
28 Nov 2018 , 11:29AM
Lupin: Ramesh Swaminathan resigns as the Chief Financial Officer of the company – sentimentally negative for the stock
-
Lupin's Tarapur facility receives EIR from USFDA
27 Nov 2018 , 12:57PM
Lupin's Tarapur facility receives Establishment Inspection Report (EIR) from USFDA
-
Lupin receives FDA approval for KCl for Oral Solution 20 mEq
27 Nov 2018 , 10:35AM
Lupin's Potassium Chloride for Oral Solution USP, 20 mEq is the generic version of Pharma Research Software Solution
-
Lupin receives USFDA approval for Clomipramine HCl Capsules
27 Nov 2018 , 10:29AM
Lupin gets nod for its Clomipramine Hydrochloride Capsule to market a generic version of SpecGx LLC's Anafranil Capsules
-
Lupin launches generic Tetrabenazine Tablets
21 Nov 2018 , 11:29AM
Lupin launches generic Tetrabenazine tablets in the US market
-
Lupin gets FDA nod for Budesonide Inhalation Suspension
13 Nov 2018 , 11:51AM
Lupin receives FDA approval for Budesonide Inhalation Suspension, 0.5 mg/2 mL
-
Lupin's Nagpur facility receives EIR from USFDA
12 Nov 2018 , 10:33AM
Lupin gets EIR report post the completion of a Pre-Approval Inspection (PAI) for its Phenytoin Sodium Extended Release 100 mg capsules
-
Lupin pithampur unit 3 gets form 483
30 Oct 2018 , 11:25AM
Lupin: Pithampur unit 3 gets Form 483 with 5 obs in a pre-approval inspection; company says obs procedural in nature; Unit 2 is under warning letter – Sentimentally negative for Lupin
-
Lupin's pithampur Unit-3 inspect by USFDA
19 Oct 2018 , 2:52PM
Lupin completes USFDA inspection carried out at its Pithampur Unit-3 (Indore) facility
-
Lupin gets FDA nod for Lurasidone Hydrochloride Tablets
15 Oct 2018 , 3:09PM
Lupin receives tentative FDA approval for generic Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg
-
Lupin launches generic Clobetasol Propionate Ointment USP in US
9 Oct 2018 , 3:30PM
Lupin's Clobetasol Propionate Ointment USP, 0.05% is the generic equivalent of Fougera Pharmaceuticals Inc.'s Temovate Ointment, 0.05%
-
Lupin enters into partnership with Lilly
1 Oct 2018 , 11:33AM
Lupin and Lilly partner for improved access to diabetes treatment in India
-
Lupin gets nod for Atovaquone Oral Suspension USP
14 Sep 2018 , 10:13AM
Lupin received approval for its Atovaquone Oral Suspension USP, 750 mg/5 ml from US FDA. It is indicated for prevention and acute oral treatment of mild-tomoderate Pneumocystis carinii pneumonia (PCP) in patients intolerant to trimethoprim-sulfamethoxazole. Positive for Stock
-
Lupin's Tarapur API manufacturing facility inspect by USFDA
4 Sep 2018 , 11:37AM
Lupin announces the completion of a cGMP inspection carried out by the USFDA at its Tarapur facility
-
Lupin gets USFDA nod to market generic version of Genus Lifesciences
31 Aug 2018 , 2:52PM
Lupin receives USFDA approval for generic Potassium Chloride Oral Solution USP
-
Lupin gets FDA nod for Gabapentin Tablets
28 Aug 2018 , 12:36PM
Lupin receives FDA approval for generic Gabapentin Tablets USP, 600 mg and 800 mg.
-
Lupin gets FDA nod for generic equivalent tablets
27 Aug 2018 , 12:17PM
Lupin launches generic Drospirenone, Ethinyl Estradiol, Levomefolate Calcium Tablets and Levomefolate Calcium Tablets, 3 mg/0.02 mg/0.451 mg and 0.451 mg
-
Lupin gets EIR from USFDA
24 Aug 2018 , 2:15PM
Lupin's Nagpur facility receives Establishment Investigation Report (EIR) from US FDA
-
Lupin up after receiving approval for generic tablets
23 Aug 2018 , 10:17AM
Lupin rises over 3% to Rs916.85, after receiving US drug regulator's tentative approval for generic Nudovra tablets
-
Lupin gets USFDA nod for Hydrocortisone Butyrate Lotion
21 Aug 2018 , 11:50AM
Lupin gets final approval for its Hydrocortisone Butyrate Lotion, 0.1% from USFDA to market a generic version of PreCision Dermatology
-
Lupin: Disappointing performance continues
10 Aug 2018 , 12:43PM
Lupin: Disappointing performance continues; Maintain Reduce with PT under review
-
Lupin gets FDA nod for its Nitrofurantoin Capsules USP
12 Jul 2018 , 2:33PM
Lupin receives final approval for its Nitrofurantoin Capsules USP (Macrocrystals), 50 mg and 100 mg from the United States Food and Drug Administration
-
Lupin gets USFDA nod for generic malaria drug
10 Jul 2018 , 12:08PM
Lupin receives approval from the US health regulator for Hydroxychloroquine Sulfate tablets, which is used to treat malaria
-
Lupin Company launches generic Tobramycin Inhalation Solution
14 Jun 2018 , 10:42AM
Positive read through for Lupin.
-
Lupin receives USFDA approval for Nystatin
5 Jun 2018 , 11:02AM
Positive read through for Lupin.
-
Lupin reports disappointing performance
16 May 2018 , 11:16AM
Maintain Reduce with PT under review.
-
Lupin submits new drug application for Etanercept biosimilar
9 May 2018 , 10:14AM
Long term positive read through for Lupin.
-
Lupin gets FDA nod for generic Temovate ointment
8 May 2018 , 11:33AM
Lupin gets final approval for its Clobetasol Propionate Ointment USP, 0.05% from the United States Food and Drug Administration
-
Lupin receives USFDA approval for gTemovate ointment
8 May 2018 , 11:09AM
Positive read through for Lupin.
-
USFDA to inspect Lupin’s formulation facility at Nagpur
7 May 2018 , 10:40AM
Lupin stock to remain in focus.
-
Lupin gets USFDA tentative nod for testosterone gel
18 Apr 2018 , 2:14PM
Lupin gets USFDA tentative nod for testosterone gel
-
Pithampur unit 1 gets EIR from USFDA
6 Apr 2018 , 1:58PM
Sentimentally positive for Lupin.
-
Lupin gets EIR from USFDA for Pithampur facility; stk up
6 Apr 2018 , 11:59AM
Lupin rises over 7% at Rs842.45, after Pithampur Unit 1 facility receives establishment investigation report from the US drug regulator
-
Lupin's goa facility successfully compeletes inspection
3 Apr 2018 , 11:39AM
Lupin rises by 3% at Rs798.1, after the UK drug regulator successfully completes its inspection of the company's Goa facility
-
Lupin's Goa facility successfully completes UKMHRA inspection with no critical or major observations
3 Apr 2018 , 11:19AM
Sentimentally positive;
-
Lupin's Pithampur unit gets Health Canada clearance
2 Apr 2018 , 2:29PM
Lupin announces that its Pithampur unit 2 manufacturing facility located in Indore has been cleared by Health Canada after a review
-
Lupin successfully gets reviewed by Health Canada
2 Apr 2018 , 12:14PM
Sentimentally positive; stock is up by 2%+
-
Lupin gets USFDA nod for psoriasis treatment spray
19 Mar 2018 , 3:36PM
Lupin secures US drug regulator's approval for a generic drug indicated for the treatment of plaque psoriasis in patients 18 years of age or older
-
Lupin signs agreement with CSIR-NCL and DST
8 Mar 2018 , 3:31PM
Lupin signs an agreement with CSIR-NCL, Pune and DST, Delhi for conducting research on a continuous purification process development of a biosimilar monoclonal antibody therapeutic
-
Lupin reports disappointing performance
7 Feb 2018 , 2:27PM
Downgrade to Reduce with our PT under review.
-
Lupin gets USFDA nod for launching generic lotion
2 Feb 2018 , 12:22PM
Lupin announces the launch of its Clobetasol Propionate Lotion 0.05% having received an approval from USFDA earlier
-
Lupin to launch regular products every 3-4 months
16 Jan 2018 , 9:19AM
Positive read through for Lupin as it plans to come up with regular product launches every 3-4 months and aims to be present across all the major OTC product categories.
-
Lupin gets USFDA nod for generic psoriasis treatment solution
29 Dec 2017 , 10:24AM
Lupin receives final approval from the USFDA to market a generic version of Dovonex scalp solution
-
USFDA approves Lupin for generic dovonex scal solution
29 Dec 2017 , 9:40AM
Stocks to remain in focus as Lupin and its peers receive USFDA approval
-
Lupin receives USFDA approval
29 Dec 2017 , 9:27AM
Positive read through as Lupin receives USFDA approval for generic Dovonex Scalp Solution
-
Lupin promoters buy 1 lakh shares
1 Dec 2017 , 2:20PM
1 lakh shares have been bought from 28-29 November 2017.
-
Yes Bank and IndusInd Bank to replace Lupin and Cipla
20 Nov 2017 , 8:46AM
Positive news for Yes bank and IndusInd as they would be replacing Lupin and Cipla in Sensex Index with effect from 18th December 2017
-
Lupin gets warning letter for two plants
8 Nov 2017 , 12:45PM
Owing to a lack of clarity and uncertainty over the outcome of the USFDA warning letters, we expect considerable de-rating of the stock.
-
Lupin gets combined warning letter from USFDA
7 Nov 2017 , 2:10PM
Negative news for Lupin as it gets combined warning letter from USFDA for its formulation manufacturing facilities at Goa and Pithampur unit – 2
-
Teva slumps as it cut its growth guidance
3 Nov 2017 , 9:18AM
Sentimentally negative news for Indian generic player (like Lupin, Sun Pharma, Glenmark, Cadila etc) as it reflects continued pricing and regulatory pressure on generic companies in US markets.
-
Lupin launches generic Acticlate tablets in US
3 Nov 2017 , 8:56AM
Positive news for Lupin as it launches generic Acticlate tablets in US.
-
Lupin's Q2 results report decline in total sales
31 Oct 2017 , 11:48AM
Lupin Limited (Lupin) reported a 7.9% decline in its total sales (including operating income) to Rs.3, 952 crore (lower than our expectation of Rs.4, 167 crore) for 2QFY2018.
-
Lupin Q2 results display mixed performance
30 Oct 2017 , 3:46PM
Lupin's sales number are below expectation due to steep decline in US sales whereas profit is above expectation due to higher other income.
-
Lupin gets USFDA final approval for carbidopa tablets
25 Oct 2017 , 12:10PM
Lupin gets USFDA final approval for its carbidopa tablets 25 mg (gLodosyn tablets) used in treatment of symptoms of idiopathic Parkinson’s disease, postencephalitic Parkinson’s and symptomatic Parkinsonism - approved drug has sales of ~Rs 140 crore.
-
Lupin gets USFDA final approval for carbidopa tablets - positive
25 Oct 2017 , 8:51AM
Lupin gets USFDA final approval for its carbidopa tablets 25 mg (gLodosyn tablets) used in treatment of symptoms of idiopathic Parkinson’s disease, postencephalitic Parkinson’s and symptomatic Parkinsonism - Positive for stock; approved drug has sales of ~Rs 140 crore.
-
Lupin bags approval for Nadolol Tablets
10 Oct 2017 , 9:54AM
Lupin receives final approval for its Nadolol Tablets USP, 20 mg, 40 mg, and 80 mg from the USFDA to market a generic version
-
Lupin receives USFDA nod for gCorgard Tablets
10 Oct 2017 , 8:55AM
Lupin receives USFDA final approval for gCorgard Tablets; used to treat chest pain & hypertension. Positive for Lupin.
-
Lupin gets USFDA nod for skin treatment lotion
26 Sep 2017 , 9:04AM
Lupin: gets USFDA approval for Clobetasol propionate topical lotion, used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash) – Positive for Lupin
-
Lupin gets USFDA approval for Doxycycline Hyclate
11 Sep 2017 , 2:30PM
Lupin gets USFDA approval for Doxycycline Hyclate tablets, – Positive for Lupin; stock is up 1%+
-
Lupin receives EIR for Aurangabad plant
22 Aug 2017 , 8:39AM
Lupin gets Establishment Inspection Report (EIR) for Aurangabad plant – Sentimentally positive for Lupin.
-
Lupin: Disappointing performance and weak guidance
4 Aug 2017 , 9:11AM
Lupin: Disappointing performance and weak guidance; Downgrade to Reduce with downward revised TP of Rs.950.
-
Lupin's sales performance for Q1FY2018 disappoints
4 Aug 2017 , 9:08AM
Disappointing performance and weak guidance; Downgrade to Reduce with downward revised TP of Rs.950.
-
Lupin reports disappointing Q1FY2018 performance
2 Aug 2017 , 2:50PM
Lupin reports disappointing Q1FY2018 performance.
-
Relief from skin inflammation as Lupin gets USFDA nod for gLidex
2 Aug 2017 , 9:54AM
Lupin gets USFDA approval for gLidex ointment, used for relief of skin diseases causing inflammation.
-
Lupin gains after FDA nod for Ancobon Capsules
10 Jul 2017 , 3:31PM
Lupin rises over 3% to Rs1156, after company receives approval from the US health regulator for generic Ancobon Capsules