Lupin gets USFDA’s approval for Tenofovir Alafenamide Tablets

31 Mar 2023 Evaluate

Lupin has received approval from the United States Food and Drug Administration (USFDA) 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, (RLD Vemlidy) had estimated annual sales of $531 million in the U.S. (IQVIA MAT December 2022).

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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