Zydus Lifesciences Limited, an Indian pharmaceutical company, has received tentative approval from the United States Food and Drug Administration (USFDA) for its Olaparib Tablets, 100 mg and 150 mg. This medication is used to treat certain types of ovarian, breast, pancreatic, and prostate cancers in patients with specific genetic mutations, specifically in the BRCA gene or other homologous recombination repair (HRR) genes.
The approval is a significant milestone for Zydus, as Olaparib tablets had annual sales of $1,379.4 million in the United States as of September 2025, according to IQVIA data. The tablets will be manufactured at Zydus Lifesciences Ltd’s Special Economic Zone (SEZ) facility. This approval marks a major achievement for the company, which has now received a total of 426 approvals and has filed 487 Abbreviated New Drug Applications (ANDAs) since it began the filing process in 2003-04.
The tentative approval of Olaparib tablets demonstrates Zydus’ commitment to providing high-quality, affordable medications to patients in the United States and globally. The company’s strong research and development capabilities, combined with its state-of-the-art manufacturing facilities, have enabled it to develop and commercialize complex medications like Olaparib.
With this approval, Zydus is well-positioned to capitalize on the growing demand for cancer treatments in the United States and other markets. The company’s portfolio of oncology products, including Olaparib, is expected to drive growth and revenue in the coming years. As a leading pharmaceutical company in India, Zydus is dedicated to improving access to affordable healthcare solutions for patients worldwide, and this approval is a significant step towards achieving that goal. Overall, the tentative approval of Olaparib tablets is a major achievement for Zydus and reflects the company’s commitment to innovation, quality, and patient care.