Zydus Lifesciences announced Monday that it has secured final approval from the US Food and Drug Administration (USFDA) for Diltiazem Hydrochloride tablets, marking the Indian pharmaceutical company's entry into the generic cardiovascular drug market in the United States.
The approval covers four tablet strengths of 30 mg, 60 mg, 90 mg, and 120 mg, providing physicians with flexible dosing options for patients with cardiovascular conditions. Diltiazem Hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm.
Mechanism of Action and Clinical Applications
Diltiazem belongs to the calcium-channel blocker class of medications and functions by relaxing blood vessels, which reduces the workload on the heart while increasing blood and oxygen supply to the heart muscle. This dual mechanism makes it particularly effective for patients experiencing chest pain related to reduced coronary blood flow.
The drug addresses two primary cardiovascular conditions: chronic stable angina, where patients experience predictable chest pain during physical exertion or stress, and vasospastic angina caused by coronary artery spasm, a condition where the coronary arteries temporarily constrict and reduce blood flow to the heart.
Manufacturing and Market Opportunity
Zydus Lifesciences plans to manufacture the Diltiazem Hydrochloride tablets at its Baddi manufacturing facility located in Himachal Pradesh, India. This production site will serve as the supply hub for the US market distribution.
According to IQVIA MAT June 2025 data, Diltiazem Hydrochloride tablets represent a significant market opportunity with annual sales of $13.9 million in the United States. This market size reflects the continued demand for calcium-channel blockers in managing cardiovascular conditions, particularly as the aging population increases the prevalence of coronary artery disease and related conditions.
The FDA approval positions Zydus Lifesciences to compete in the established generic cardiovascular drug market, where multiple formulations of diltiazem are already available. The company's entry with four different strengths provides comprehensive coverage for the typical dosing range used in clinical practice.
