161h June, 2021, Vadodara, India

PRESS RELEASE 161h June, 2021, Vadodara, India Alembic Pharmaceuticals announces its joint venture Aleor Dermaceuticals receives USFDA Final Approval for Testosterone Topical Solution USP, 30 mg per pump actuation. Alembic Pharmaceuticals Limited (Alembic) today announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Testosterone Topical Solution USP, 30 mg per pump actuation. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Axiron Topical Solution, 30 mg per pump actuation, of Eli Lilly and Company (Lilly). Testosterone Topical Solution USP, 30 mg per pump actuation is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypoqonadisrn (congenital or acquired). Testosterone Topical Solution USP, 30 mg per pump actuation has an estimated market size of US$ 21 million for twelve months ending March 2021 according to IQVIA. Alembic has a cumulative total of 145 ANDA approvals (127 final approvals and 18 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) (Bloornberq: ALPM) (NSE: APLL TD) (BSE: 533573). About Aleor Dermaceuticals Limited Aleor is a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologies Pvt Ltd (Orbicular) formed in Apr' 16 focusing on commercialising dermatology products globally. 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, 22808~0. • FA~ : (0265) 2281229. websit~: www.alembicpharmaceuticals.com •E-mail: [email protected] • CIN: L24230GJ2010PLC061123

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