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Alembic Pharma Gets Final NoD From USFDA for Tretinoin Cream

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Alembic Pharmaceuticals (NSE:APLLTD, BOM:533573) has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Tretinoin Cream USP, 0.05%, according to a Friday filing on Indian exchanges.

The product is a generic version of Retin-A Cream, 0.05%, of Bausch Health US and is used for the topical treatment of acne vulgaris, the filing said.

It has an estimated U.S. market size of $76 million for the 12 months ended March 2026, Alembic said, citing IQVIA data.

Shares of the company fell 1% in recent trade.

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