9th July, 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 9th July, 2024, Vadodara, India Alembic Pharmaceu ticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%. 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) for Bromfenac Ophthalmic Solution, 0.07%. The approved ANDA is ther apeutically equivalent to the reference listed drug product (RLD), Prolensa Ophthalmic Solution, 0.07%, of Bausch & Lomb In corporated (Bausch). Bromfenac Ophthalmic S olution 0.07% is a nonsteroidal anti -inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Refer label for a detailed indication. Bromfenac Ophthalmic Solution, 0.07% has an estimated market size of US$ 168 million for twelve months ending March 2024 according to IQVIA. Alembic has a cumulative total of 207 ANDA approvals (180 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. Alembic'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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