Zydus bags USFDA nod for chronic stable angina drug Diltiazem Hydrochloride
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-08-11 06:00 GMT | Update On 2025-08-11 06:00 GMT
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Ahmedabad: Zydus Lifesciences Limited has announced that the company 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.
Last year, the firm received he USFDA approval to manufacture and market Isosorbide Mononitrate Extended-Release, Tablets USP, 30 mg, 60 mg, and 120 mg (USRLD: Imdur Extended-Release Tablets), used for prevention of chest pain (angina) in patients with a certain heart condition (coronary artery disease).
Read also: Zydus Lifesciences secures USFDA okay for angina drug Isosorbide Mononitrate ER
In July 2025, the company also received NOC (Notice of Compliance) from Health Canada for ZDS-Varenicline tablets 0.5 &1 mg.
Read also: Zydus Lifesciences gets NOC from Health Canada for ZDS-Varenicline tablets
Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 27,000 people worldwide, including 1,400 scientists engaged in R & D. Over the last decade, Zydus has introduced several innovative, first-in-class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.
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