22nd April, 2019, Vadodara, India

PRESS RELEASE 22nd April, 2019, Vadodara, India Alembic Pharmaceuticals receives US FDA Approval for Tobramycin Ophthalmic Solution USP, 0.3%. Alembic Pharmaceuticals Limited today announced that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tobramycin Ophthalmic Solution USP, 0.3%. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Tobrex Ophthalmic Solution, 0.3%, of Novartis Pharmaceuticals Corporation. Tobramycin Ophthalmic Solution USP, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Tobramycin Ophthalmic Solution USP, 0.3% have an estimated market size of US$ 9.6 million for twelve months ending December 2018 according to IQVIA. Alembic now has a total of 92 ANDA approvals (80 final approvals and 12 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 the company can be found at http://www.alembicpharmaceuticals.com/; (Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLL TD) (BSE: 533573) For more information contact: Ajay Kumar Desai Phone: +91 22 - 306 11681 Mitanshu Shah Phone: +91 265 - 3007630 Email: [email protected] Email: [email protected] 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

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