Zydus receives final approval from USFDA for Enzalutamide Capsules, 40 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 Enzalutamide Capsules, 40 mg (USRLD: Xtandi® Capsules, 40 mg).

Enzalutamide capsules are androgen receptor inhibitors indicated for the treatment of patients with metastatic castration-resistant prostate cancer. Enzalutamide Capsules will be produced at the Group's manufacturing site at Moraiya, Ahmedabad.

Enzalutamide capsules, 40 mg had annual sales of USD 869.4 mn in the United States (IQVIA MAT July 2024).

The group now has 400 approvals and has so far filed over 465* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 1074.60 as compared to the previous close of Rs. 1068.35. The total number of shares traded during the day was 106233 in over 6732 trades.

The stock hit an intraday high of Rs. 1078.00 and intraday low of 1041.55. The net turnover during the day was Rs. 112619336.00.

(*as of 30th June 2024)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 Pharmaceuticals FinalApproval USFDA EnzalutamideCapsules