Alembic Pharma Gets USFDA Nod for Tretinoin Cream

19 Aug 2025 , 10:13 AM

Alembic Pharmaceuticals has received the green light from the US Food and Drug Administration (USFDA) for its Tretinoin Cream USP, 0.025%. The company’s Abbreviated New Drug Application (ANDA) has been cleared as the generic equivalent of Retin-A Cream 0.025%. This is marketed in the United States by Bausch Health US, LLC. Tretinoin Cream is prescribed for topical use in the treatment of acne vulgaris.

According to market research firm IQVIA, the US market for this formulation is estimated at around $94 million for the 12 months ending June 2025. With this approval, Alembic’s cumulative tally of ANDAs now stands at 224. Out of this 202 are final approvals and 22 are tentative approvals.

Founded in 1907, Alembic is among India’s oldest pharmaceutical companies. Over the years, it has evolved into a fully integrated player with research-driven operations. Its manufacturing facilities are cleared by global regulators, including the USFDA.

Apart from its international generics business, Alembic holds a strong position in India’s branded generics market, supported by a field force of more than 5,500 professionals. Its products are widely prescribed and recognised across therapeutic categories.

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