Zydus Lifesciences gets USFDA’s final approval for Apalutamide Tablets

19 Mar 2025 Evaluate

Zydus Lifesciences 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 $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 (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.


Zydus Lifesciences Share Price

877.50 -8.20 (-0.93%)
01-Apr-2025 16:59 View Price Chart
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