4th October, 2019, Vadodara, India

PRESS RELEASE 4th October, 2019, Vadodara, India Alembic Pharmaceuticals announces its joint venture Aleor Dermaceuticals receives USFDA Approval for Clobetasol Propionate Spray, 0.05%. Alembic Pharmaceuticals Limited (Alembic) today announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received approval from. the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Clobetasol Propionate Spray, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Clobex® Spray, 0.05% of Galderma Laboratories L.P. (Galderma). Clobetasol Propionate Spray, 0.05% is indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. Clobetasol Propionate Spray, 0.05%, has an estimated market size of US$ 22 million for twelve months ending December 2018 according to IQVIA. Alembic has a cumulative total of 103 ANDA approvals (91 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). 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 alernbic.eo.in ALEMBIC PHARMACEUTICALS LiMITED REGD. OFFICE : ALEMBIC ROAD, VADODARA - 390 003. • TEL : (()265) 2280550, 2280880 • FAX : (0265) 2281229 website : www.alembicpharmaceuticah;.com • E-mail : [email protected] • CIN : L24230GJ2010PLC061123

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