Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Tretinoin Cream USP, 0.05 percent. The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Retin-A Cream, 0.05 percent, of Bausch Health US, LLC.

Tretinoin cream is indicated for topical application in the treatment of acne vulgaris.

Tretinoin Cream USP, 0.05 percent, has an estimated market size of USD 76 million for 12 months ending March 2026, according to IQVIA.

Alembic has a cumulative total of 242 ANDA approvals (222 final approvals and 20 tentative approvals) from FDA.