Alembic Pharmaceuticals has secured a fresh regulatory win in the United States, announcing that it has received final approval from the FDA for its Abbreviated New Drug Application for Tretinoin Cream USP.

 

The approval clears the company to market a generic version that is therapeutically equivalent to Retin-A Cream, 0.05%, originally manufactured by Bausch Health. The product is indicated for the topical treatment of acne vulgaris, with full usage details outlined in the official label.

 

The opportunity is backed by meaningful market potential. According to IQVIA estimates, Tretinoin Cream USP, 0.05% represents a market size of approximately US$ 76 million for the twelve months ending March 2026.

 

With this latest clearance, Alembic continues to strengthen its footprint in the US generics space. The company now holds a cumulative total of 242 ANDA approvals, including 222 final approvals and 20 tentative approvals from the USFDA.