Zydus Lifesciences Gets USFDA Tentative Nod for Olaparib Tablets; Q2 Profit Surges 39%

10 Nov 2025 , 08:59 AM

Zydus Lifesciences Ltd announced on Friday (November 7) that it has received tentative approval from the US Food and Drug Administration (USFDA) to market Olaparib Tablets, 100 mg and 150 mg. The product is a generic version of Lynparza Tablets developed by AstraZeneca.

Olaparib is prescribed for the treatment of specific ovarian, breast, pancreatic, and prostate cancers in patients with BRCA gene mutations or other homologous recombination repair (HRR) abnormalities. The approved tablets will be manufactured at the company’s SEZ facility in India.

According to IQVIA MAT data for September 2025, Olaparib tablets recorded annual US sales of $1,379.4 million, reflecting a large market opportunity for the Indian drugmaker. With this approval, Zydus’ total count of approved products has reached 426, out of 487 ANDA filings made since FY2003–04.

For the quarter ended September 2025 (Q2 FY26), Zydus Lifesciences reported a 39% year-on-year jump in consolidated net profit to ₹1,259 crore, compared with ₹911 crore in the same quarter last year.

The growth was supported by a sharp foreign exchange gain of ₹414 crore, up from ₹45 crore a year earlier. Revenue grew 17% year-on-year to ₹6,123 crore, driven by strong traction in both the US generics and India formulations businesses.

The company’s EBITDA surged 38% to ₹2,014 crore, while EBITDA margin expanded to 32.9% from 27.9% a year ago. Zydus attributed the margin expansion to a richer product mix and tight cost discipline across key markets.

Research and development (R&D) expenses stood at ₹482 crore, accounting for 7.9% of revenue, underscoring the company’s ongoing focus on innovation and complex generics.

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