Mumbai, Baltimore, August 25, 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 Tablets, 267 mg and 801 mg, to market a generic equivalent of Esbriet® Tablets, 267 mg and 801 mg of Hoffmann La Roche Inc. This product will be manufactured at Lupin’s Pithampur facility in India.
Pirfenidone Tablets (RLD Esbriet®) had estimated annual sales of USD 218 million in the U.S. (IQVIA MAT June 2023).
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.
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Vice President & Global Head – Corporate Communications & Sustainability
*Safe Harbor Statement
Esbriet® is the registered trademark of Genentech, Inc.