Natco Pharma received USFDA tentative approval for generic Olaparib tablets, a version of AstraZeneca’s Lynparza. Natco will manufacture, Alembic will distribute in the US.
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Natco Pharma Ltd. has received tentative approval from the US Food and Drug Administration (USFDA) for Olaparib Tablets in 100 mg and 150 mg strengths, the generic version of AstraZeneca’s Lynparza tablets, the company said in a press release. The approval covers the indications in the approved labelling.
Natco said it will manufacture the Olaparib tablets, while its partner, Alembic Pharmaceuticals Ltd., will distribute the product in the US.
The company added that the Para IV litigation is ongoing. According to industry sales data cited by Natco, Olaparib tablets recorded estimated sales of approximately $1.4 billion in the US during the 12 months ended March 2026.
Shares of Natco Pharma Ltd. ended 2.40% lower at ₹943.00 on the NSE.
