Lupin receives tentative USFDA nod for Tenofovir Alafenamide Tablets

19 Apr 2022 , 12:26 PM

Global pharma major Lupin Limited has announced that it 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, Inc. (Gilead). This product will be manufactured at Lupin’s Nagpur facility in India.

Further, Tenofovir Alafenamide Tablets (RLD: Vemlidy Tablets) had estimated annual sales of USD484.2 million in the U.S. (IQVIA MAT December 2021).

At around 12;28 PM, Lupin was trading at Rs772.15 apiece up by Rs1.55 or 0.2% from its previous closing of Rs770.60 apiece on the BSE.