3rd October, 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 3rd October, 2024, Vadodara, India Alembic Pharmaceuticals announces USFDA Final A pproval for Alcaftadine Ophthalmic Solution, 0.25% (OTC). Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Alcaftadine Ophthalmic Solution, 0.25% (OTC). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lastacaft Solution, 0.25%, of AbbVie Inc. (AbbVie). Alcaftadine Ophthalmic Solution, 0.25% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander. Refer label for a detailed indication. Alembic has a cumulative total of 216 ANDA approvals (189 final approvals and 27 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. A lembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic's brands, marketed through a marketing team of over 5000 are well recognized by doctors and patients. Information about Alembic can be found at https://www.alembicpharmaceuticals.com/; (Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLLTD) (BSE: 533573). For more information contact: Ajay Kumar Desai Phone: +91 22-66953681| 7045504460 Email: [email protected]

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