20th April, 2020, 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 20th April, 2020, Vadodara, India Alembic Pharmaceuticals announces USFDA Tentative Approval for Alcaftadine Ophthalmic Solution, 0.25%. Alembic Pharmaceuticals Limited (Alembic) today announced it ha s received tentative approval from the US Food & Drug Administration (USFDA) for its Abbrevia ted New Drug Application (ANDA) Alcaftadine Ophthalmic Solution, 0.25%. The approved AND A is therapeutically equivalent to the reference listed drug product (RLD) Lastacaft Ophthalmic Solution, 0.25%, of Allergan, Inc. (Allergan). Alcaftadine Ophthalmic Solution is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. Alcaftadine Ophthalmic Solution, 0.25% has an estimated market size of US$ 7 million for twelve months ending December 2019 according to IQVIA. Alembic has a cumulative total of 120 ANDA approvals (107 final approvals and 13 tentative approvals) from USFDA. About Alembic Pharmaceuticals Limited Alembic Pharmaceuticals Limited, a vertically integrated resear ch 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 researc h 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 http://www.alembicpha rmaceuticals.com/; (Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLLTD) (BSE: 533573) For more information contact: Ajay Kumar Desai Phone: +91 22 - 306 11681 Email: [email protected] Mitanshu Shah Phone: +91 265 - 3007630 Email: [email protected]

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