The approval covers strengths of 30 mg, 60 mg, 90 mg and 120 mg.
The product is the generic version of Cardizem, sold by Bausch Health. The medicine is used to manage chronic stable angina and angina caused by coronary artery spasm.
Alembic said this approval adds to its strong US portfolio. The company now has 230 ANDA approvals. These include 210 final 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.
The company’s consolidated net profit jumped 20.40% to Rs 184.71 crore in Q2 FY26, compared to Rs 153.41 crore posted in Q2 FY25. Revenue from operations grew 15.90% year on year (YoY) to Rs 1,910.15 crore in Q2 September 2025.