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Zydus Lifesciences up 2% after USFDA nods Diltiazem Hydrochloride tablets
At 11:40 AM, Zydus Lifesciences share price was up 1.91 per cent at ₹953.4 per share on BSE. In comparison, the Sensex was 0.26 per cent higher at 80,065.50.
'Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as 'Zydus') 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),' the filing read.
Diltiazem Hydrochloride Tablets will be produced at Zydus Lifesciences Ltd, Baddi, Himachal Pradesh. Diltiazem Hydrochloride Tablets had annual sales of $13.9 mn in the US (IQVIA MAT June 2025).
Diltiazem Hydrochloride tablets help manage 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.
That apart, in July, the company had received tentative approval from the US health regulatory agency for its generic version of the cancer treatment drug Ibrutinib tablets.
The tentative approval granted by the US FDA is for Ibrutinib tablets of strengths 140 mg, 280 mg, and 420 mg, Zydus Lifesciences said in a statement.
The Ibrutinib tablets will be produced at Zydus Lifesciences Ltd SEZ, Ahmedabad, it added.
The company said Ibrutinib is indicated for the treatment of adult patients with different types of blood cancers, Chronic lymphocytic leukaemia (CLL)/Small lymphocytic lymphoma (SLL), and Waldenstrom's macroglobulinemia (WM). Citing IQVIA MAT May 2025, Zydus said Ibrutinib tablets had annual sales of USD 2148.9 million in the US.
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