Mumbai, June 12 -- The approved product is therapeutically equivalent to the reference listed drug, Retin-A Cream, 0.05%, marketed by Bausch Health US, LLC. Tretinoin Cream is used for the topical treatment of acne vulgaris.

According to IQVIA data, the approved product has an estimated market size of approximately $76 million for the 12 months ended March 2026.

With this approval, Alembic Pharmaceuticals has received a cumulative total of 242 ANDA approvals from the USFDA, comprising 222 final approvals and 20 tentative approvals.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufactur...