4th March, 2021, Vadodara, India
2021-03-01 · Alembic Pharmaceuticals Ltd. · original alembicpharmaceuticals.com ↗
PRESS RELEASE 4th March, 2021, Vadodara, India Alembic Pharmaceuticals announces its joint v·enture Aleor Dermaceuticals receives USFDA Final Approval for Testosterone Gel, 1.62% (20.25 mg/1.25 gm 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 Gel, 1.62% (20.25 mg/1.25 gm actuation). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), AndroGel 1.62%, of AbbVie Inc. (AbbVie). Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation) is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism ( congenital or acquired) and Hypogonadotropic hypogonadism (congenital or acquired). Aleor had previously received tentative approval for this ANDA. . Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation) has an estimated market size of US$ 86 million for twelve months ending December 2020 according to IQVIA. Alembic has a cumulative total of 138 ANDA approvals (122 final approvals and 16 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 Email: [email protected] Phone: +91 265 - 3007630 Email: [email protected] ALEMBIC PHARMACEUTICALS LIMITED REG~. OFFICE : 'ALEMBIC ROAD,,.VADODARA - 390 003. • TEL : (0265) 2280550, 228088.0. • FA~ : (0265) 2281229. website : www.a_lembicpharmaceuticals.com • E-mail : [email protected] • CIN : L24230GJ2010PLC061123
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