ALEMBIC PHARMACEUTICALS : NATCO RECEIVES USFDA TENTATIVE APPROVAL FOR OLAPARIB TABLETS

• Alembic's partner NATCO Pharma Limited has received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Olaparib Tablets, 100 mg and 150 mg. • The approved ANDA is therapeutically equivalent to the reference listed drug product, Lynparza Tablets, 100 mg and 150 mg, of AstraZeneca. • Alembic will distribute the product in the U.S., and NATCO will manufacture the tablets. • Olaparib Tablets, 100 mg and 150 mg, have an estimated market size of approximately USD 1.4 billion in the U.S. for the twelve months ending March 2026. • Alembic has a cumulative total of 244 ANDA approvals from USFDA, including 224 final and 20 tentative approvals.

Alembic Pharmaceuticals Limited

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