Lupin Secures FDA Tentative Approval for Enzalutamide Tablets

Lupin’s application covers a range of strengths, including 40 mg, 80 mg, 120 mg, and 160 mg tablets. While the 40 mg and 80 mg versions are recognized as bioequivalent to the reference listed drug, the inclusion of 120 mg and 160 mg doses offers clinicians and patients expanded flexibility in dosing regimens that differ from the standard Xtandi configuration. This development strengthens the company’s position in the U.S. oncology market, where it already maintains a broad footprint across cardiovascular, respiratory, and central nervous system therapy areas. Headquartered in India, the manufacturer operates 15 production sites and 7 research centers worldwide, supporting a portfolio that spans generic formulations and complex biotechnology products. The company currently employs over 24,000 professionals and distributes pharmaceutical goods across more than 100 international markets.