Zydus gets USFDA nod for apalutamide tablets

Zydus Lifesciences (BSE: 532321) announced today that it has received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture Apalutamide Tablets, 60 mg. This medication is indicated for treating patients with metastatic castration-sensitive prostate cancer. The company plans to produce the tablets at its Zydus Lifesciences Ltd (SEZ) facility in Ahmedabad. According to IQVIA data, Apalutamide tablets recorded annual sales of USD 1099.8 million in the United States as of January 2025. As of December 31, 2024, Zydus has 420 approvals and has filed 483 ANDAs since beginning its filing process in FY 2003-04. This approval marks a significant milestone for Zydus, strengthening its presence in the U.S. pharmaceutical market.