Zydus Life receives USFDA approval for manufacturing Apalutamide tablets, 60 mg

Zydus Lifesciences said that it has received final approval from the United States Food and Drug Administration (US FDA) to manufacture Apalutamide tablets, 60 mg.

Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. Apalutamide tablets will be produced at Zydus Lifesciences (SEZ), Ahmedabad.

Apalutamide tablets had annual sales of $1099.8 million in the United States (IQVIA MAT January 2025).

The group now has 420 approvals and has so far filed 483 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company reported a 29.62% jump in consolidated net profit of Rs 1,023.5 crore in Q3 FY25 compared with Rs 789.6 crore in Q3 FY24. Revenue from operations increased 16.96% YoY to Rs 5,269.1 crore during the quarter.

Shares of Zydus Lifesciences rose 0.57% to Rs 908.25 on the BSE.

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