19th May, 2020, Vadodara, India
2020-05-01 · Alembic Pharmaceuticals Ltd. · original alembicpharmaceuticals.com ↗
PRESS RELEASE 19th May, 2020, Vadodara, India Alembic Pharmaceuticals announces its joint venture, Aleor Dermaceuticals receives USFDA Approval for Clobetasol Propionate Shampoo, 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 Shampoo, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Clobex Shampoo, 0.05%, of Galderma Laboratories, L.P. (Galderma). Clobetasol Propionate Shampoo, 0.05% is indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. Clobetasol Propionate Shampoo, 0.05%, has an estimated market size of US$ 28 million for twelve months ending December 2019 according to IQVIA. Alembic has a cumulative 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 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 Email: [email protected] Mitanshu Shah Phone: +91 265 - 3007630 Email: [email protected] 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
The release as fetched from its publisher. alembicpharmaceuticals.com ↗