15th June, 2020, Vadodara, India

PRESS RELEASE 15th June, 2020, Vadodara, India Alembic Pharmaceuticals receives USFDA Final Approval for Deferasirox Tablets, 180 mg. Alembic Pharmaceuticals Limited today announced that the Company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Deferasirox Tablets, 180 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Jadenu Tablets, 180 mg, of Novartis Pharmaceuticals Corporation (Novartis). Deferasirox tablets are indicated for treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) and for treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes. Alembic had previously received final approval for Deferasirox Tablets, 90 mg and 360 mg and tentative approval for Deferasirox Tablets, for 180 mg. Deferasirox Tablets, 180 mg have an estimated market size of US$ 53 million for twelve months ending March 2020 according to IQVIA. Alembic now has a total of 122 ANDA approvals (109 final approvals and 13 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 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: mitanshu.shah alembic.co.in 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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