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Zydus Lifesciences Gets USFDA Nod for Olaparib Tablets, Shares Rise 1%

Zydus Lifesciences
The tablets will be made at Zydus Lifesciences’ formulation facility in Ahmedabad SEZ.

Shares of Zydus Lifesciences Ltd rose 1% to touch a day’s high of Rs 973 on 10th November, after the company announced on Friday, 7th November, that it had 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 used to treat certain types of ovarian, breast, pancreatic, and prostate cancers in patients with specific genetic mutations, particularly in the BRCA or HRR genes. The tablets will be manufactured at Zydus Lifesciences’ SEZ facility.

According to IQVIA MAT data for September 2025, Olaparib tablets recorded annual sales of $1,379.4 million in the US. Zydus Lifesciences now has 426 approvals and has filed 487 ANDAs since FY 2003–04.

Zydus Lifesciences Second Quarter Results

Zydus Lifesciences reported a 39% year-over-year rise in consolidated net profit to Rs 1,259 crore, compared with Rs 911 crore in the same quarter last year. The company recorded a foreign exchange gain of Rs 414 crore, up from Rs 45 crore a year earlier.

R&D spending stood at Rs 482 crore, or 7.9% of revenue, reflecting its focus on innovation and complex generics. Quarterly revenue rose 17% year-over-year to Rs 6,123 crore, driven by strong growth in the US and India formulations businesses.

Operating performance also improved, with EBITDA rising 38% to Rs 2,014 crore. Margins expanded to 32.9% from 27.9% a year earlier, supported by a better product mix and cost discipline.

At 1:31 PM, shares of Zydus Lifesciences were trading 0.94% higher at Rs 952.95 on NSE.

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