Zydus receives USFDA approval for Diltiazem Hydrochloride Tablets in multiple strengths
Approval covers 30 mg, 60 mg, 90 mg, and 120 mg tablets for the management of chronic stable angina and angina due to coronary artery spasm
Zydus Lifesciences, including its subsidiaries and affiliates, has received final approval from the United States Food and Drug Administration (USFDA) for Diltiazem Hydrochloride Tablets USP in strengths of 30 mg, 60 mg, 90 mg, and 120 mg. The approved product is the generic equivalent of Cardizem Tablets in the same strengths.
Diltiazem Hydrochloride Tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm. The product belongs to a class of medicines known as calcium-channel blockers. Diltiazem works by relaxing blood vessels, which reduces the workload on the heart and increases the blood and oxygen supply to the heart muscle.
According to the company, the tablets will be manufactured at Zydus Lifesciences, Baddi, Himachal Pradesh. As per IQVIA MAT June 2025 data, Diltiazem Hydrochloride Tablets had annual sales of USD 13.9 million in the United States.
Zydus stated that it now has 423 product approvals and has filed 483 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04, as of 31 July 2025.