Alembic Pharmaceuticals, in partnership with NATCO Pharma Limited, has received tentative approval from the USFDA for Olaparib Tablets (100 mg and 150 mg). The product is therapeutically equivalent to AstraZeneca’s reference drug, Lynparza. Key Highlights: Partnership Roles: NATCO Pharma will handle the manufacturing, while Alembic Pharmaceuticals will manage the U.S. distribution and supply chain. Market Opportunity: The U.S. market for Olaparib Tablets is estimated at approximately $1.4 billion (12 months ending March 2026, per IQVIA), representing a significant commercial opportunity. Regulatory Milestone: This brings Alembic’s cumulative USFDA ANDA approvals to 244 (224 final and 20 tentative), reinforcing its strong footprint in the complex generics market. Litigation Status: Para IV litigation for this product is currently ongoing, which may impact the timeline for final approval and commercial launch. Strategic Outlook: This tentative approval is a strong strategic win for the Alembic-NATCO partnership, positioning them to capture a meaningful share of a high-value oncology generic market. Investors will closely monitor the resolution of the Para IV litigation, as a favorable outcome or settlement will be the key trigger for actual revenue realization. $APLLTD $NATCOPHARM

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