Alembic Pharma JV Aleor Dermaceuticals gets USFDA nod for Adapalene Gel
Adapalene Gel USP, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Vadodara: Alembic Pharmaceuticals Limited has announced that its joint venture Aleor Dermaceuticals Limited has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Adapalene Gel USP, 0.3%.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Differin Gel, 0.3%, of Galderma Laboratories, L.P. Adapalene Gel USP, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Adapalene Gel USP, 0.3% has an estimated market size of US $ 34 million for twelve months ending March 2020 according to IQVIA.
Alembic has a cumulative total of 123 ANDA approvals ( 110 final approvals and 13 tentative approvals) from USFDA.
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company headquartered in Gujarat.
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.