Zydus receives final approval from USFDA for Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg

Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg (USRLD: Cardizem® Tablets, 30 mg, 60 mg, 90 mg, and 120 mg).

Diltiazem Hydrochloride Tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm.  It belongs to a class of drugs called calcium-channel blockers. Diltiazem works by relaxing blood vessels, which reduces the workload on the heart and increases blood and oxygen supply to the heart muscle. Diltiazem Hydrochloride Tablets will be produced at Zydus Lifesciences Ltd, Baddi, Himachal Pradesh. Diltiazem Hydrochloride Tablets had annual sales of USD 13.9 mn in the United States (IQVIA MAT June 2025).

The group now has 423 approvals and has so far filed 483* ANDAs since the commencement of the filing process in FY 2003-04.