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Business Standard
2 days ago
- Business
- Business Standard
Zydus Lifesciences up 2% after USFDA nods Diltiazem Hydrochloride tablets
Zydus Lifesciences shares rose 2 per cent on Monday, August 11, 2025, and logged an intra-day high at ₹955 per share on BSE. The buying interest on the counter came after US Food and Drugs Administration (USFDA) gave its approval for 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.
Business Upturn
2 days ago
- Business
- Business Upturn
Zydus Lifesciences gets USFDA final approval for Diltiazem Hydrochloride tablets
By Aman Shukla Published on August 11, 2025, 10:10 IST Zydus Lifesciences Limited, along with its subsidiaries and affiliates (collectively referred to as 'Zydus'), has secured final approval from the United States Food and Drug Administration (USFDA) for its Diltiazem Hydrochloride Tablets USP in multiple strengths: 30 mg, 60 mg, 90 mg, and 120 mg. These tablets will be marketed under the brand name Cardizem® Tablets in the US. Diltiazem Hydrochloride Tablets are widely prescribed for managing chronic stable angina and angina caused by coronary artery spasms. Classified as calcium-channel blockers, these tablets work by relaxing blood vessels, thereby reducing the heart's workload and improving blood and oxygen flow to the heart muscle. This approval allows Zydus to manufacture the drug at its state-of-the-art facility in Baddi, Himachal Pradesh. According to IQVIA MAT data from June 2025, Diltiazem Hydrochloride Tablets generated annual sales of USD 13.9 million in the United States, highlighting the product's strong market demand. With this recent approval, Zydus has achieved a total of 423 USFDA approvals and has filed 483 ANDAs (Abbreviated New Drug Applications) since it began filing in the fiscal year 2003-04. This milestone underscores Zydus' commitment to expanding its footprint in the competitive US pharmaceutical market. Ahmedabad Plane Crash Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
