USFDA11 Aug 2025, 10:09 am
Zydus Lifesciences Ltd Receives USFDA Approval for Diltiazem Hydrochloride Tablets
AI Summary
Zydus Lifesciences Limited has received final approval from the USFDA for Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg. The tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm, and will be produced at Zydus Lifesciences Ltd, Baddi, Himachal Pradesh. The group now has 423 approvals and has so far filed 483 ANDAs since the commencement of the filing process in FY 2003-04. Diltiazem Hydrochloride Tablets had annual sales of USD 13.9 mn in the United States (IQVIA MAT June 2025).
Key Highlights
- Zydus Lifesciences Ltd receives final approval from USFDA for Diltiazem Hydrochloride Tablets USP, 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
- The tablets will be produced at Zydus Lifesciences Ltd, Baddi, Himachal Pradesh
- Zydus Lifesciences Limited now has 423 approvals
- Diltiazem Hydrochloride Tablets had annual sales of USD 13.9 mn in the United States (IQVIA MAT June 2025)