Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated August 15, 2025, titled "Alembic Pharmaceuticals Limited announces USFDA Final Approval for Tretinoin Cream USP, 0.025%.".
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Alembic Pharmaceuticals has received final approval from the USFDA for its generic version of Tretinoin Cream USP, 0.025%, used to treat acne vulgaris. The approved product is therapeutically equivalent to Bausch Health's Retin-A Cream, 0.025%. According to IQVIA, this cream has an estimated US market size of US$ 94 million for the twelve months ending June 2025. With this approval, Alembic's cumulative ANDA count has reached 224, comprising 202 final approvals and 22 tentative approvals. The company already has USFDA-approved manufacturing and R&D facilities and markets generics globally.
Positive for shareholders — adds another product to Alembic's US generics portfolio, tapping into a ~US$94 million addressable market and strengthening its pipeline of 224 ANDA approvals which supports future US revenue growth.