Alembic Pharmaceuticals has secured USFDA final approval for Diltiazem Hydrochloride Tablets USP in multiple strengths (30 mg, 60 mg, 90 mg, and 120 mg). The approved ANDA is therapeutically equivalent to Cardizem Tablets and indicated for managing chronic stable angina. This approval adds to Alembic’s growing portfolio of ANDA approvals from the USFDA, reinforcing its presence in the US market.
USFDA Approval Received
Alembic Pharmaceuticals Limited announced 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.
Tablet Strengths Approved
The approval encompasses Diltiazem Hydrochloride Tablets in strengths of 30 mg, 60 mg, 90 mg, and 120 mg.
Therapeutic Equivalence
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Cardizem Tablets, in the same strengths manufactured by Bausch Health US, LLC. Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm.
ANDA Approval Totals
Alembic Pharmaceuticals now holds a cumulative total of 230 ANDA approvals, comprising 210 final approvals and 20 tentative approvals from the USFDA as of November 2025.
Source: BSE