Zydus receives tentative approval from USFDA for Olaparib Tablets, 100 mg and 150 mg

Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as "Zydus") has received tentative approval from the United States Food and Drug Administration (USFDA) for Olaparib Tablets, 100 mg and 150 mg (USRLD: Lynparza Tablets, 100 mg and 150 mg).

Olaparib is indicated for treatment of certain types of ovarian, breast, pancreatic, and prostate cancers in patients who have specific genetic mutations (specifically in the BRCA gene or other homologous recombination repair [HRR] genes). Olaparib tablets will be produced at Zydus Lifesciences Ltd, SEZ. Olaparib tablets had annual sales of USD 1,379.4 mn in the United States (IQVIA MAT Sept-2025).

The group now has 426 approvals and has so far filed 487* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 943.80 as compared to the previous close of Rs. 936.25. The total number of shares traded during the day was 17982 in over 1228 trades.

The stock hit an intraday high of Rs. 945.80 and intraday low of 927.00. The net turnover during the day was Rs. 16840132.00.

(*As on 30-Sept-25)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 Pharmaceuticals TentativeApproval USFDA OlaparibTablets