Alembic Pharmaceuticals gets USFDA nod for Diltiazem Hydrochloride tablets

Alembic Pharmaceuticals Limited announced on November 15, 2025, that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Tablets USP, in 30 mg, 60 mg, 90 mg, and 120 mg strengths. These tablets are therapeutically equivalent to Cardizem Tablets, the reference listed drug, and are indicated for the management of chronic stable angina and angina due to coronary artery spasm.

This latest approval increases Alembic's cumulative total of ANDA approvals to 230, comprising 210 final approvals and 20 tentative approvals from the USFDA.

Alembic Pharmaceuticals, headquartered in India, is a publicly listed research and development pharmaceutical company with global operations and USFDA-approved manufacturing facilities. Established in 1907, the company maintains a strong presence in branded generics in India.