Latest news with #ZydusLifesciencesLimited
Business Upturn
16 hours 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
Business Upturn
3 days ago
- Business
- Business Upturn
Zydus Lifesciences gets USFDA nod for Prucalopride tablets, 1 mg and 2 mg
Zydus Lifesciences Limited has received final approval from the US Food and Drug Administration (USFDA) to market Prucalopride Tablets, 1 mg and 2 mg (reference listed drug: Motegrity® ). The tablets are indicated for the treatment of chronic idiopathic constipation (CIC) — a condition in which the cause of constipation is unknown and persistent. Prucalopride works by stimulating natural peristalsis in the colon, thereby aiding regular bowel movements. With this approval, Zydus adds another feather to its cap in the US generics market. The approved tablets will be manufactured at the company's SEZ facility in Ahmedabad, Gujarat. According to IQVIA MAT data for June 2025, Prucalopride tablets had annual sales of USD 186.8 million in the US market. This approval strengthens Zydus' position in the gastrointestinal segment and adds to its growing US portfolio. With this latest nod, the group has now received 422 approvals since it began filing ANDAs (Abbreviated New Drug Applications) in FY 2003-04. In total, Zydus has filed 483 ANDAs so far. 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
Business Upturn
11-06-2025
- Business
- Business Upturn
Zydus receives USFDA EIR for Ankleshwar API facility with ‘No Action Indicated' status
By News Desk Published on June 11, 2025, 18:24 IST Zydus Lifesciences Limited announced on Wednesday that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its API manufacturing facility located in Ankleshwar, Gujarat. The inspection, which was carried out between March 10 and March 14, 2025, has been classified as 'No Action Indicated' (NAI), indicating that the USFDA found no objectionable conditions during its assessment. The inspection is now officially closed, the company confirmed in a press release dated June 11, 2025. This development is seen as a positive regulatory milestone for Zydus, ensuring continued compliance and uninterrupted operations at its active pharmaceutical ingredient (API) facility. The company has disclosed the update under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, and has submitted the information to both BSE (Code: 532321) and NSE (Symbol: Zyduslife). Shares of Zydus Lifesciences may react to this regulatory update when markets open. News desk at
Business Upturn
03-06-2025
- Business
- Business Upturn
Zydus secures licensing rights for next-gen immuno-oncology platforms from US-based Agenus
Zydus Lifesciences Limited, including its subsidiaries and affiliates ('Zydus'), has entered into an agreement with Agenus Inc. (NASDAQ: AGEN) to acquire the commercial rights for its investigational Botensilimab (BOT) and Balstilimab (BAL), combination therapy. Agenus is a clinical-stage immuno-oncology company focused on developing immune therapies for cancer treatment. The BOT/BAL combination is an immunotherapy currently in advanced clinical trials. It has shown clinical activity in studies involving over 1,200 patients with nine different types of cancer, in both late-stage and neoadjuvant treatment settings. Under the agreement, Zydus will handle clinical development and regulatory approvals for BOT/BAL in India and Sri Lanka. Upon successful approval and commercialization, Zydus will pay Agenus a 5% royalty on net sales. Zydus will also work on expanding the use of BOT/BAL beyond its initial indications to other areas with unmet medical needs and earlier treatment stages, including neoadjuvant therapy. 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
Business Upturn
02-06-2025
- Business
- Business Upturn
Zydus receives tentative USFDA approval for Rifaximin Tablets, 550 mg
By Aman Shukla Published on June 2, 2025, 08:12 IST Zydus Lifesciences Limited, along with its subsidiaries and affiliates (collectively referred to as 'Zydus'), has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg. The approved product is a generic version of Xifaxan® Tablets, 550 mg, which is indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. The tablets will be manufactured at the company's SEZ II facility in Ahmedabad, India. According to IQVIA MAT data for March 2025, Rifaximin Tablets, 550 mg, recorded annual sales of approximately USD $2,672.9 million in the U.S. market. With this tentative approval, Zydus now has a total of 427 ANDA approvals. Since beginning its ANDA filings in the financial year 2003–04, the company has submitted 492 ANDAs to date. 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
