Pharma major Lupin Limited on Monday said that it has received tentative approval from US drug regulator for tenofovir alafenamide tablets used for treating chronic Hepatitis B infection.
United States Food and Drug Administration (FDA) approved Tenofovir Alafenamide Tablets, 25 mg, to market a generic equivalent of Vemlidy Tablets, 25 mg, of Gilead Sciences, Inc. (Gilead), the Mumbai-based pharma company said in a regulatory filing.
This product will be manufactured at Lupin's Nagpur facility in India.
Tenofovir alafenamide tablets had estimated annual sales of $484.2 million in the US, Lupin further stated.
To clarify, tenofovir alafenamide, sold under the brand name Vemlidy, is a hepatitis B virus nucleotide reverse transcriptase inhibitor medication for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease. It is taken by mouth. Tenofovir alafenamide is a prodrug of tenofovir.
Lupin develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APls in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. It is the third-largest pharmaceutical company in the US by prescriptions. The company invested 9.6 per cent of its revenue in research and development in FY21.
Shares of Lupin Ltd on Monday traded 0.32 per cent lower at Rs 769.90 apiece on BSE during late trade.
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