Lupin receives tentative approval from US FDA for Tenofovir Alafenamide tabs

The product will be manufactured at Lupin’s Nagpur facility in India

Lupin has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Tenofovir Alafenamide Tablets, 25 mg, to market a generic equivalent of Vemlidy Tablets, 25 mg, of Gilead Sciences, (Gilead). The 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.