Latest news with #ZydusLifesciencesLimited
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
Business Standard
21-05-2025
- Business
- Business Standard
Zydus' Net Profit up by 23% in FY 25
BusinessWire India Ahmedabad (Gujarat) [India], May 21: Zydus Lifesciences Limited announced financial results for the quarter / year ended on March 31, 2025. Key Financial Highlights FY25 - Revenue from operations up by 19% at Rs. 2,32,415 mn, over last year. - Net Profit, adjusted for exceptional items, was Rs. 47,451 mn, up 23% YoY. - EBITDA for the year was Rs. 70,585 mn, up 31% YoY. EBITDA margin for the year stood at 30.4%, which is an improvement of 290 bps over the previous year. - Net Debt to Equity ratio as on 31st March, 2025 was -0.20x while Net Debt to EBITDA stood at -0.69x at the end of March, 2025. Net Cash (negative Net Debt) as on March 31st, 2025 was Rs. 48,836 mn . -Research & Development (R & D) investments for the year stood at Rs. 18,555 mn (8.0% of revenues). -The Board recommended a dividend of 1100%. Q4 FY25 - Revenue from operations up by 18% at Rs. 65,279 mn, over last year. - EBITDA for the quarter was Rs. 21,255 mn, up 30% YoY. EBITDA margin for the quarter stood at 32.6%, which is an improvement of 310 bps on a YoY basis. -Net Profit up 18% yoy at Rs. 13,905 mn (adjusted for exceptional items). -Research & Development (R & D) investments for the quarter stood at Rs. 4,799 mn (7.4% of revenues). Speaking on the results, Dr. Sharvil Patel, Managing Director Zydus Lifesciences said, "We are happy to conclude FY 2025 on a strong note, with all our businesses surpassing our growth expectations. The commercial success of our extensive product portfolio combined with operating leverage has significantly bolstered profitability and financial health. We made meaningful progress in our differentiated pipeline and added new capabilities to ensure sustainable growth. We look forward to continued execution success and deepening strategic partnerships to drive long term growth. Our commitment to maintaining the highest quality standards across our operations remains unwavering."
Time of India
20-05-2025
- Business
- Time of India
Zydus Lifesciences FY 25 net profit rises 17%; co declares Rs 11 dividend
AHMEDABAD: Homegrown pharma major, Zydus Lifesciences Limited , on Tuesday reported a 17.3% rise in consolidated net profit for FY 2025 at Rs 4,525.5 crore, up from Rs 3,859.5 crore in the previous year, driven by strong US and India sales. The board recommended a final dividend of Rs 11 per equity share, subject to shareholder approval at the AGM on 12 August 2025. For the March quarter (Q4), net profit fell marginally by 1.0% to Rs 1,170.9 crore from Rs 1,182.3 crore a year earlier, impacted by a one-time loss of Rs 220 crore. Adjusted for this, net profit rose 18% year-on-year to Rs 1,390.5 crore. Revenue for the quarter rose 18% to Rs 6,528 crore, while full-year revenue grew 19% to Rs 23,241.5 crore. The US formulations business was the standout, growing 27.2% to Rs 11,050 crore annually. In constant currency terms, quarterly US sales stood at $363 million, boosted by volume growth and five new launches. The US now contributes nearly half of the company's topline. In India, branded formulations rose 10.1% to Rs 5,931.5 crore, and the consumer wellness segment grew 16.5% to Rs 2,681 crore, together accounting for 39% of overall revenue. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like New Trend Lets Indians Access Benefits Up to ₹2,00,00,000 India News Learn More Undo Chronic therapies now make up 43% of the domestic branded portfolio. EBITDA for the quarter rose 30% to Rs 2,125.5 crore, with margins improving to 32.6%. For the year, EBITDA climbed 31% to Rs 7,058.5 crore, with a 30.4% margin. Net cash surplus stood at Rs 4,883.6 crore as of 31 March 2025. R&D spend was Rs 479.9 crore for Q4 and Rs 1,855.5 crore for the year. Other international formulation markets contributed Rs 2,194.7 crore, while API revenue dipped 1.0% to Rs 560.2 crore. MD Dr Sharvil Patel said the company exceeded growth expectations and would continue investing in innovation and partnerships for sustainable growth.
