2nd November, 2022, 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 2nd November, 2022, Vadodara, India Alembic Pharmaceuticals receives USFDA Final Approval for Mesalamine Extended-Release Capsules USP, 0.375 g. 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 Mesalamine Extended-Release Capsules USP, 0.375 g. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Apriso Extended -Release Capsules, 0.375 g, of Salix Pharmaceuticals, Inc. (Salix). Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults. Mesalamine Extended-Release Capsules USP, 0.375 g, have an estimated market size of US$ 133 million for twelve months ending June 2022 according to IQVIA. Alembic has a cumulative total of 174 ANDA approvals (150 final approvals and 24 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 Ind ia, 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 - 306 11681 Email: [email protected] Mitanshu Shah Phone: +91 265 - 6637630 Email: [email protected]

The release as fetched from its publisher. alembicpharmaceuticals.com ↗