Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Cardizem Tablets, 30 mg, 60 mg, 90 mg, and 120 mg, of Bausch Health US, LLC.
Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm. The company has a cumulative total of 230 ANDA approvals (210 final approvals and 20 tentative approvals) from USFDA.
Alembic Pharmaceuticals (Alembic Pharma) is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.
