Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Apalutamide Tablets, 60 mg (Erleada 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 Ltd (SEZ), Ahmedabad.

Apalutamide tablets had annual sales of US $1,099.8 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.