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Alembic Pharma gains after partner NATCO receives USFDA tentative nod for Olaparib tablets

20-Jul-26 15:25Hrs IST

The approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug (RLD), Lynparza Tablets, 100 mg and 150 mg, marketed by AstraZeneca Pharmaceuticals LP, for the indications specified in the approved labelling.

Under the partnership arrangement, NATCO Pharma will manufacture the Olaparib tablets, while Alembic Pharmaceuticals will distribute the product in the United States.

Olaparib, marketed under the brand name Lynparza, is a targeted cancer therapy belonging to the class of PARP inhibitors. It is indicated for the treatment of certain types of ovarian, breast, pancreatic and prostate cancers by preventing cancer cells with specific genetic mutations, such as BRCA or HRR mutations, from repairing damaged DNA.

The company said the Paragraph IV (Para IV) patent litigation related to the product is ongoing. According to IQVIA, Olaparib Tablets, 100 mg and 150 mg, had an estimated U.S. market size of approximately $1.4 billion for the 12 months ended March 2026.

With this approval, Alembic Pharmaceuticals now has a cumulative total of 244 ANDA approvals from the USFDA, comprising 224 final approvals and 20 tentative approvals.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA.

The company's consolidated net profit jumped 29.19% to Rs 202.70 crore in Q4 FY26, compared to Rs 156.89 crore posted in Q4 FY25. Revenue from operations grew 4.41% year on year (YoY) to Rs 1,847.72 crore in the quarter ended 31 March 2026.

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