12th November, 2024, Vadodara, India

ALEMBIC PHARMACEUTICALS LIMITED REGD. OFFICE: ALEMBIC ROAD, VADODARA - 390 003. ● TEL: (0265) 2280550, 2280880 ● FAX: (0265) 2281229 Website : www.alembicpharmaceuticals.com ● E-mail : [email protected] ● CIN : L24230GJ2010PLC061123 PRESS RELEASE 12th November, 2024, Vadodara, India Alembic Pharmaceuticals Limited announces USFDA Final Approval for Ivabradine Tablets, 5 mg and 7.5 mg. Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ivabradine Tablets, 5 mg and 7.5 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Corlanor Tablets, 5 mg and 7.5 mg, of Amgen Inc. (Amgen) . Ivabradine is a hyperpolarization -activated cyclic nucleotide -gated channel blocker indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. Refer label for a detailed indication. Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US$ 145.3 million for twelve months ending September 2024 according to IQVIA. Alembic has a cumulative total of 218 ANDA approvals (19 2 final approvals and 2 6 tentative approvals) from USFDA. About Alembic Pharmaceuticals Limited Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many devel oped countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic's brands, marketed throu gh a field force of over 5200 are well recognized by doctors and patients. Information about the Company can be found at www.alembicpharmaceuticals.com; (Reuters:ALEM.NS) (Bloomberg:ALPM) (NSE:APLLTD) (BSE:533573) For more information, contact: Ajay Kumar Desai Phone: +91 22-66953681 Email: [email protected]

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