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Lupin Ltd — Regulatory Filings 2023
Aug 29, 2023
61031_rns_2023-08-29_e441694e-fe4c-49ec-b725-ed9d89e1d724.pdf
Regulatory Filings
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August 29, 2023
BSE Limited Department of Corporate Services, P. J. Towers, Dalal Street, MUMBAI - 400 001.
National Stock Exchange of India Limited Exchange Plaza, Bandra Kurla Complex, Bandra (East), Mumbai - 400 051.
Dear Sir/Madam,
Sub: Disclosure pursuant to Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) 2015 (‘Listing Regulations’).
We are pleased to enclose a Press release regarding receipt of U.S. FDA approval for the Company’s Abbreviated New Drug Application for Pirfenidone Capsules, 267 mg, to market a generic equivalent of Esbriet[®] Capsules, 267 mg of Hoffmann La Roche Inc.
This may kindly be considered as a disclosure pursuant to Regulation 30 of the Listing Regulations.
The above is for your information and dissemination.
Thanking you,
For LUPIN LIMITED
Rajvardhan Vishnu Satam
Digitally signed by Rajvardhan Vishnu Satam DN: c=IN, st=Maharashtra, 2.5.4.20=c19d8ef961d9fa59e973a093a4d3924b2532eb2f496ea7e 2abcf74700f5375b7, postalCode=400104, street=2404,SEJAL TOWER,SEJAL PARK,LINK ROAD,GOREGAON WEST,Mumbai,Motilal Nagar,Borivali,Mumbai Suburban, pseudonym=9a4b7cd219ea516ad56e6d651dcbbe5b, title=0191, serialNumber=df8ebe60a88c796663c738ea25bfa0b475d195f726 cdb67a2ff09c4242771b2a, o=Personal, cn=Rajvardhan Vishnu Satam Date: 2023.08.29 12:25:34 +05'30'
R. V. SATAM COMPANY SECRETARY (ACS - 11973)
Encl: a/a
Registered Office: 3[rd] Floor, Kalpataru Inspire, Off W. E. Highway, Santacruz (East), Mumbai - 400 055 India. Tel: (91-22) 6640 2323. Corporate Identity Number: L24100MH1983PLC029442 www.lupin.com
www.lupin.com
Press Release
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BSE: 500257 NSE: LUPIN REUTERS: LUPIN.BO
BLOOMBERG: LPCIN
Lupin Receives Approval from U.S. FDA for Pirfenidone Capsules
Mumbai, Baltimore, August 29, 2023 : Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Pirfenidone Capsules, 267 mg, to market a generic equivalent of Esbriet® Capsules, 267 mg of Hoffmann La Roche Inc. This product will be manufactured at Lupin’s Pithampur facility in India.
Pirfenidone Capsules (RLD Esbriet®) had estimated annual sales of USD 95 million in the U.S. (IQVIA MAT June 2023).
About Lupin
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
Please visit www.lupin.com for more information. Follow us on: Twitter: https://twitter.com/LupinGlobal LinkedIn: https://www.linkedin.com/company/lupin Facebook: http://www.facebook.com/LupinWorld/
For further information or queries please contact –
Shweta Munjal
Vice President & Global Head – Corporate Communications & Sustainability Email: [email protected]
*Safe Harbor Statement
Esbriet® is the registered trademark of Genentech, Inc.
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