5th June, 2019, Vadodara, India

PRESS RELEASE 5th June, 2019, Vadodara, India Alembic Pharmaceuticals receives USFDA Approval for Carbidopa and Levodopa Extended-Release Tablets USP, 25 mg/100 mg and 50 mg/200 mg. 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) Carbidopa and Levodopa Extended-Release Tablets USP, 2.5 mg/100 mg and 50 mg/200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sinemet CR Tablets, 25 mg/100 mg and 50 mg/200 mg, of Merck Sharp & Dohme Corp. Carbidopa and Levodopa Extended-Release Tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa and Levodopa Extended-Release Tablets USP, 25 mg/100 mg and 50 mg/200 mg have an estimated market size of US$ 24 million for twelve months ending December 2018 according to IQVIA. Alembic now has a total of 95 ANDA approvals (83 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 Mitanshu Shah Phone: +91 22 - 306 11681 Phone: +91 265 - 3007630 Email: [email protected] Email: [email protected] ALEMBIC PHARMACEUTICALS LIMITED REGO. 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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