Zydus Lifesciences secures USFDA tentative approval for Olaparib tablets

Zydus Lifesciences Ltd on Friday (November 7) said it 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 the 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. The tablets will be manufactured at Zydus Lifesciences Ltd, SEZ.

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Olaparib tablets recorded annual sales of $1,379.4 million in the United States, according to IQVIA MAT for September 2025. The group now has 426 approvals and has filed 487 ANDAs since the commencement of the filing process in FY 2003–04.

Second Quarter Results

Zydus Lifesciences' consolidated net profit rose 39% year-on-year to ₹1,259 crore, compared with ₹911 crore in the same period last year. The company recorded a foreign exchange gain of ₹414 crore, compared with ₹45 crore in the previous year.

Research and development (R&D) expenditure stood at ₹482 crore, or 7.9% of revenue, reflecting continued investment in innovation and complex generics. Revenue for the quarter climbed 17% year-on-year to ₹6,123 crore, led by strong performance in the company’s US and India formulations businesses.

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Operating profitability improved significantly, with EBITDA surging 38% to ₹2,014 crore, while margins expanded to 32.9% from 27.9% a year earlier, aided by a richer product mix and disciplined cost control.

Shares of Zydus Lifesciences Ltd ended at ₹943.80, up by ₹7.55, or 0.81%, on the BSE.