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Alembic Pharmaceuticals Limited (Alembic) today announced that its wholly owned subsidiary, Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Epiduo Forte Topical Gel, 0.3%/2.5%, of Galderma Laboratories, L.P. (Galderma). Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.
Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% has an estimated market size of US$211 million for twelve months ending Mar 2022 according to IQVIA. Alembic has received a cumulative total of 170 ANDA approvals (146 final approvals and 24 tentative approvals) from USFDA.
