The approved ANDA is therapeutically equivalent to Aczone Gel, 5%, of Almirall, LLC, and is indicated for the topical treatment of acne vulgaris. With this approval, Alembic Pharmaceuticals now has a cumulative total of 244 ANDA approvals from the USFDA, comprising 224 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.