Lupin Hepatitis B virus drug gets USFDA okay

Mumbai: Global pharma major Lupin Limited has announced that the company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Tenofovir Alafenamide Tablets, 25 mg.

The product is a generic equivalent of Vemlidy Tablets, 25 mg, of Gilead Sciences, Inc.

Tenofovir alafenamide is indicated for the treatment of chronic hepatitis B virus infection in patients with compensated liver disease.

This product will be manufactured at Lupin’s Nagpur facility in India. Tenofovir Alafenamide Tablets, 25 mg, (RLD Vemlidy) had estimated annual sales of USD 531 million in the U.S. (IQVIA MAT December 2022).

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Lupin is a 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 specializes 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. The company invested 8.7% of its revenue in research and development in FY22. 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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