- Strengthens US portfolio with back-to-back clearances across cardiac and gastro therapies
- New approvals add to Alembic’s growing ANDA pipeline of over 230 authorisations
- Products deemed therapeutically equivalent to leading brands Cardizem and Dexilant
NE BUSINESS BUREAU
MUMBAI, NOV 19
Alembic Pharmaceuticals Limited has announced two significant milestones with the US Food & Drug Administration granting final approvals for Diltiazem Hydrochloride Tablets USP (30 mg, 60 mg, 90 mg, 120 mg) and Dexlansoprazole Delayed-Release Capsules (30 mg, 60 mg).
The cardiac drug Diltiazem, approved as a therapeutic equivalent to Bausch Health’s Cardizem, is indicated for chronic stable angina and angina due to coronary artery spasm. The second approval covers Dexlansoprazole, a proton pump inhibitor comparable to Takeda’s Dexilant, indicated for healing and maintenance of erosive esophagitis, relief from heartburn, and treatment of symptomatic GERD in patients aged 12 and above. The Dexlansoprazole market in the US is estimated at US$ 285 million for the 12 months ending September 2025 (IQVIA).
With these clearances, Alembic’s cumulative ANDA approvals stand at over 230, reinforcing the company’s momentum and deepening its presence in key therapeutic segments in the US generics market.
