Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tretinoin Cream USP, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.05%, of Bausch Health US, LLC. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris.
Tretinoin Cream USP, 0.05%, has an estimated market size of $76 million for twelve months ending March 2026 according to IQVIA.
Alembic has a cumulative total of 242 ANDA approvals (222 final approvals and 20 tentative approvals) from USFDA.
Alembic Pharmaceuticals is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.
