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( As on 12/06/2026 13:20)

Alembic Pharma receives USFSDA approval for tretinoin cream

Alembic Pharmaceuticals Ltd. has received final approval from the U.S. Food and Drug Administration for its Tretinoin Cream USP, 0.05%.

The approval has been granted for the company's Abbreviated New Drug Application (ANDA), and the product is therapeutically equivalent to Retin-A Cream marketed by Bausch Health US LLC. Tretinoin Cream is used as a topical treatment for Acne Vulgaris.

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

With this approval, Alembic's cumulative USFDA tally has reached 242 ANDA approvals, comprising 222 final approvals and 20 tentative approvals, further strengthening the company's presence in the U.S. generic pharmaceuticals market.