Alembic Pharma gains after receiving USFDA nod for Tretinoin Cream

Alembic Pharmaceuticals rose 1.33% to Rs 744.75 after the company announced that it had received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tretinoin Cream USP, 0.05%.

The approved product is therapeutically equivalent to the reference listed drug, Retin-A Cream, 0.05%, marketed by Bausch Health US, LLC. Tretinoin Cream is used for the topical treatment of acne vulgaris.

According to IQVIA data, the approved product has an estimated market size of approximately $76 million for the 12 months ended March 2026.

With this approval, Alembic Pharmaceuticals has received a cumulative total of 242 ANDA approvals from the USFDA, comprising 222 final approvals and 20 tentative approvals.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA.

The company?s consolidated net profit jumped 29.19% to Rs 202.70 crore in Q4 FY26, compared to Rs 156.89 crore posted in Q4 FY25. Revenue from operations grew 4.41% year on year (YoY) to Rs 1,847.72 crore in the quarter ended 31 March 2026.

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