Zydus Lifesciences Limited, along with its subsidiaries and affiliates (collectively referred to as “Zydus”), has secured final approval from the United States Food and Drug Administration (USFDA) for its Diltiazem Hydrochloride Tablets USP in multiple strengths: 30 mg, 60 mg, 90 mg, and 120 mg. These tablets will be marketed under the brand name Cardizem® Tablets in the US.
Diltiazem Hydrochloride Tablets are widely prescribed for managing chronic stable angina and angina caused by coronary artery spasms. Classified as calcium-channel blockers, these tablets work by relaxing blood vessels, thereby reducing the heart’s workload and improving blood and oxygen flow to the heart muscle. This approval allows Zydus to manufacture the drug at its state-of-the-art facility in Baddi, Himachal Pradesh.
According to IQVIA MAT data from June 2025, Diltiazem Hydrochloride Tablets generated annual sales of USD 13.9 million in the United States, highlighting the product’s strong market demand.
With this recent approval, Zydus has achieved a total of 423 USFDA approvals and has filed 483 ANDAs (Abbreviated New Drug Applications) since it began filing in the fiscal year 2003-04. This milestone underscores Zydus’ commitment to expanding its footprint in the competitive US pharmaceutical market.
