Zydus receives final approval from USFDA for Apalutamide Tablets, 60 mg

Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as "Zydus") 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 USD 1099.8 mn 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.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 903.10 as compared to the previous close of Rs. 893.30. The total number of shares traded during the day was 18708 in over 1637 trades.

The stock hit an intraday high of Rs. 905.70 and intraday low of 893.35. The net turnover during the day was Rs. 16864460.00.

(*As on 31st December, 2024.)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 Pharmaceuticals USFDA FinalApproval ApalutamideTablets