Shares of Alembic Pharmaceuticals Ltd rose more than 2% on Monday, 18 August, after the company announced that it had achieved final USFDA approval. 

In its regulatory filing, the company said that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tretinoin Cream USP, 0.025%.  

The product is a generic version of Bausch Health’s 0.025% Retin-A Cream and is intended for the topical treatment of acne vulgaris. According to IQVIA research, the cream’s market size is predicted to be USD 94 million for the 12 months ending June 2025.

With this approval, Alembic’s total ANDA approvals now stand at 224, with 202 final and 22 tentative. The business stated that the clearance strengthens its dermatology product portfolio in the United States. 

Alembic Pharmaceuticals, a vertically integrated research-driven company, manufactures and markets generic medications worldwide. In its most recent financial results, the company reported a 14.18% year-on-year growth in consolidated net profit to Rs 156.63 crore for Q1 June 2025, while revenue from operations increased by 9.54% to Rs 1,710.72 crore.

At 1:48 pm, the shares of Alembic Pharma were trading 1.34% higher at Rs 969.75 on NSE.

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