Alembic Pharmaceuticals shares rose 1.33% to ₹744.75 following the company's announcement of receiving final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tretinoin Cream USP, 0.05%. According to reports from Business Standard, the approved product is therapeutically equivalent to the reference listed drug, Retin-A Cream, 0.05%, marketed by Bausch Health US, LLC.
As reported by Business Standard, 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. The product represents a significant market opportunity in the dermatological therapeutics segment.
According to reports from Business Standard, 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. The company maintains its position as a vertically integrated research and development pharmaceutical company that manufactures and markets generic pharmaceutical products globally.
As reported by Business Standard, the company's consolidated net profit jumped 29.19% to ₹202.70 crore in Q4 FY26, compared to ₹156.89 crore posted in Q4 FY25. Revenue from operations grew 4.41% year on year (YoY) to ₹1,847.72 crore in the quarter ended 31 March 2026. The company's research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA.
