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Company News Details

Lupin Ltd
Industry :  Pharmaceuticals - Indian - Bulk Drugs & Formln
BSE Code
ISIN Demat
Book Value()
500257
INE326A01037
659.0470742
NSE Symbol
P/E(TTM)
Mar.Cap( Cr.)
LUPIN
18.89
109095.68
EPS(TTM)
Face Value()
Div & Yield %
126.28
2
0.75
 

Lupin Ltd
Lupin receives USFDA tentative approval for Enzalutamide Tablets
Jun 26,2026

Lupin today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Enzalutamide Tablets, 40 mg, 80 mg, 120 mg, and 160 mg.

The U.S. FDA has tentatively approved Lupin's Enzalutamide Tablets, 40 mg and 80 mg as bioequivalent to reference listed drug (RLD) Xtandi® Tablets of Astellas for the indication in the approved labeling. While Xtandi Tablets are traditionally available in 40 mg and 80 mg strengths, Lupin's tentatively approved 120 mg and 160 mg strengths will provide healthcare providers and patients with alternative dosing options.

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