Alembic Pharma gets USFDA nod for acne vulgaris cream

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-08-16 06:24 GMT   |   Update On 2025-08-16 06:24 GMT
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VadodaraAlembic Pharmaceuticals Limited has announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tretinoin Cream USP, 0.025%.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.025%, of Bausch Health US, LLC.

Tretinoin cream is indicated for topical application in the treatment of acne vulgaris.

Tretinoin cream USP, 0.025%, has an estimated market size of US$ 94 million for twelve months ending June 2025 according to IQVIA.

Alembic has a cumulative total of 224 ANDA approvals (202 final approvals and 22 tentative approvals).

Read also: Alembic Pharma ropes in Dr Sachin Ghosalkar as Sr Vice President - SCM & Operations

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. 

Read also: Alembic Pharma gets USFDA nod for anticonvulsant drug Carbamazepine Extended Release

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