US FDA Approves Diltiazem Hydrochloride Tablets by Zydus Lifesciences

Zydus Lifesciences has received final approval from the US FDA for its Diltiazem Hydrochloride Tablets. The company's stock has surged on the news, with a 7.5% increase in intraday trading. The approval marks a significant milestone for Zydus Lifesciences, expanding its product portfolio in the US market.

Zydus Lifesciences Limited has announced the receipt of final approval from the United States Food and Drug Administration (USFDA) for its Diltiazem Hydrochloride Tablets USP. The company's stock surged on the news, gaining 7.5% in intraday trading to Rs 942 on the Bombay Stock Exchange (BSE). This approval marks a significant milestone for Zydus Lifesciences, expanding its product portfolio in the US market.

The Diltiazem Hydrochloride Tablets, available in strengths of 30 mg, 60 mg, 90 mg, and 120 mg, are indicated for managing chronic stable angina and angina due to coronary artery spasm. The drug is a calcium-channel blocker that relaxes blood vessels, reducing the heart's workload and increasing blood and oxygen supply to the heart muscle. The tablets will be manufactured at Zydus Lifesciences Ltd in Baddi, Himachal Pradesh.

The approval comes at a time when Zydus Lifesciences is experiencing robust growth. According to IQVIA MAT June 2025 data, Diltiazem Hydrochloride Tablets had annual sales of USD 13.9 million in the United States. As of July 31, 2025, the group has 423 approvals and has filed 483 ANDAs since FY 2003-04 [1].

The approval of Diltiazem Hydrochloride Tablets is expected to further strengthen Zydus Lifesciences' position in the US pharmaceutical market. The company's ability to secure regulatory approval for new products is a testament to its commitment to innovation and quality.

References:
[1] https://www.tradingview.com/news/moneycontrol:c3ac28c5c094b:0-zydus-lifesciences-gains-usfda-nod-for-diltiazem-hydrochloride-tablets/