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Company News Details

Lupin Ltd
Industry :  Pharmaceuticals - Indian - Bulk Drugs & Formln
BSE Code
ISIN Demat
Book Value()
500257
INE326A01037
531.5387173
NSE Symbol
P/E(TTM)
Mar.Cap( Cr.)
LUPIN
16.63
87731.12
EPS(TTM)
Face Value()
Div & Yield %
115.47
2
0.62
 

Lupin Ltd
Lupin receives USFDA tentative approval for Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets
Sep 24,2025

Lupin has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg.

This product would be manufactured at Lupin's Nagpur facility in India.

Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg are bioequivalent to Biktarvy® Tablets, 50 mg/200 mg/25 mg of Gilead Sciences, Inc., and indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg.

Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets (RLD Biktarvy®) had estimated annual sales of USD 16,237 million in the U.S. (IQVIA MAT July 2025).

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