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Lupin gets US FDA approval for generic Vemlidy tablets

Our Bureau, Mumbai
Friday, March 31, 2023, 15:30 Hrs  [IST]

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application 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 tablets, 25 mg, (Vemlidy) had estimated annual sales of USD 531 million in the US (IQVIA MAT December 2022).

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 US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.


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