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Alembic Pharma gets USFDA nod for ticagrelor tablets

May 2, 2025 at 07:08 PM UTCBy FilingReader AI

Alembic Pharmaceuticals (BSE:APLLTD) announced today it has received US Food & Drug Administration (USFDA) final approval for its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets, 90 mg, and tentative approval for the 60 mg version. The approved ANDA is therapeutically equivalent to AstraZeneca's Brilinta, indicated to reduce the risk of cardiovascular events. Alembic was amongst the first ANDA applicants for the 90 mg tablet, with a paragraph IV certification. The market size for Ticagrelor Tablets, 90 mg, is estimated at USD 1,062 million, and USD 242 million for the 60 mg version, for the twelve months ending March 2025, according to IQVIA. With this latest approval, Alembic’s cumulative ANDA approvals from the USFDA now total 222.

This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com

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