Zydus' Matoda facility completes Remote Regulatory Assessment of USFDA
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Business Standard
an hour ago
- Business Standard
Aarti Drugs rises after Q1 PAT jumps 62% YoY to Rs 54 cr
Aarti Drugs jumped 4.22% to Rs 544.70 after the company's consolidated net profit climbed 62.2% to Rs 53.91 crore on 6.3% increase in revenue from operations to Rs 590.51 crore in Q1 FY26 compared with Q1 FY25. Profit before tax (PBT) rose 16.2% YoY to Rs 51.11 crore in Q1 June 2025. EBITDA jumped 12% to Rs 74.4 crore in Q1 FY26 compared with Rs 66.1 crore in Q1 FY25. EBITDA margin expanded by 70 bps to 12.6% in Q1 FY26 from 11.9% posted in Q1 FY25. On segmental front, the revenue from API stood at Rs 458.2 crore (up 4% YoY), formulations was at Rs 80.3 crore (up 14% YoY), specialty & chemicals stood at Rs 33.1 crore (up 24% YoY) and intermediaries & others stood at Rs 18.9 crore (up 22% YoY) during the period under review. Adhish Patil, CFO & COO, of Aarti Drugs, said, During Q1FY26 the Company incurred Capex of ~Rs. 48.5 crores mainly towards capacity expansion, backward integration and finished formulation R&D. For FY26, we expect Capex at around Rs 150-200 crore. The company has started trial productions at its new greenfield manufacturing facility in Sayakha, Gujarat. This plant has been set up mainly for backward integration into anti-diabetic products and their intermediates, and is expected to largely serve internal requirements. This backward integration is a key strategic step that should help improve profit margins over time and reduce the risk of input costs volatility. This project will support internal requirements for our anti-diabetic product and choline chloride, contributing to backward integration, margin improvement, and supply chain de-risking. The new greenfield Salicylic Acid plant at Tarapur is progressing well and is expected to begin contributing to the companys financials from the third quarter onwards. The company is now focused on a calibrated ramp-up of operations, with a clear roadmap to scale production to over 800 tonnes per month and further expand the installed capacity to approximately 1,600 tonnes per month by the end of FY26. Recently, the USA government has announced high tariffs on pharmaceutical products and APIs imported from countries like China. This move is aimed at reducing their dependence on Chinese suppliers. This has the potential to reshape global supply chains. While this may disrupt sourcing patterns for several players, it also opens up new opportunities for Indian API manufacturers. The company, with a recently USFDA approved API facility and established manufacturing capabilities, is strategically positioned to meet this demand shift. The commissioning of new capacity at Sayakha and Tarapur supports this readiness and enhances the Company's ability to serve regulated export markets. Our formulation subsidiary has also got USFDA approval for its Oncology facility & UKMHRA approval for our OSD facility; alongside we are on a path to develop and register new oncology dossiers across the globe which will drive the regulated market growth from FY27 onwards. Aarti Drugs was established in the year 1984 and forms part of $6 Billion Aarti Group of Industries. The company is engaged in the manufacturing of active pharmaceutical ingredients (APIs), pharma intermediates, speciality chemicals and produces formulations with its wholly-owned subsidiary-Pinnacle Life Science.
Business Standard
7 hours ago
- Business Standard
Stock Alert: Reliance Industries, HDFC Bank, ICICI Bank, Yes Bank, Dr Reddys Lab
Securities In F&O Ban: Angel One, Bandhan Bank, Hindustan Copper and RBL Bank shares are banned from F&O trading on 21 July 2025. Upcoming Results: Agi Greenpac, CIE Automotive India, CRISIL, DCM Shriram, Dodla Dairy, Eternal, Ganesh Housing Corporation, Havells India, IDBI Bank, Latent View Analytics, Mahindra Logistics, Oberoi Realty, Parag Milk Foods, PNB Housing Finance, Rajratan Global Wire, Sagar Cements, UCO Bank, UltraTech Cement will announce their result later today. Stocks to Watch: Reliance Industries' (RIL) profit after tax and share of profit/(loss) of associates & JVs increased by 76.5% year-on-year (Y-o-Y) to Rs 30,783 crore in Q1 June 2025. The company's gross revenue increased by 6% Y-o-Y to Rs 273,252 crore in Q1 June 2025. Yes Bank reported 59.43% surge in standalone net profit to Rs 801.07 crore in Q1 FY26 as against Rs 502.43 ecrore posted in Q1 FY25. The banks total income rose 4.82% YoY to Rs 9,348.11 crore in the quarter ended 30 June 2025. ICICI Bank reported a standalone net profit of Rs 12,768.21 crore in Q1 FY26, up 15.45% as against Rs 11,059.11 crore posted in Q1 FY25. Total income increased 11.85% year on year (YoY) to Rs 51,451.81 crore in Q1 FY26. HDFC Bank's profit after tax (PAT) for the quarter ended June 2025 was at Rs 18,155.21 crore, a growth of 12.24% over the quarter ended June 2024. Net interest income (interest earned less interest expended) for the quarter ended June 2025 grew by 5.4% to Rs 31,440 crore from Rs 29,840 crore for the quarter ended June 2024. RBL Banks standalone net profit tumbled 46.07% to Rs 200.33 crore in Q1 FY26 as against Rs 371.52 crore posted in Q1 FY25. However, total income increased 4.85% year on year (YoY) to Rs 4,510.57 crore in the quarter ended 30 June 2025. Firstsource Solutions wholly owned subsidiary, Firstsource Solutions UK has executed a share purchase agreement with Pastdue Credit Solutions (PDC) to acquire 100% stake in PDC for a consideration of GBP 22 million, including upfront payment & earnouts. Dr Reddys Laboratories announced that United States Food & Drug Administration (USFDA) completed a GMP and a Pre-Approval Inspection (PAI) at its formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh, India. USFDA issued a Form 483 with 7 observations.
Time of India
18 hours ago
- Time of India
Zydus Life's plans for cancer biosimilar hit a legal hurdle
Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads Mumbai: The Delhi High Court has issued an interim injunction against Ahmedabad-based drug maker Zydus Lifesciences after a case filed by the US pharma giant Bristol Myers Squibb alleging patent infringement on its blockbuster anticancer drug Opdyta nivolumab ) branded as Opdivo in other restraining order comes as a setback for the Indian drug maker which was running clinical trials in India for the launch of the biosimilar versions of nivolumab. The earliest patent for the drug expires in India on May 2, 2026. The next hearing for the case is August 101-page order issued on July 18 by Justice Mini Pushkarna ruled that the defendants, and all others acting on its behalf, are restrained from manufacturing, using, selling, offering for sale, importing, exporting, advertising, or dealing in any biosimilar/similar biologic of nivolumab, the suit patent, during the pendency of the present suit. The order stated the plaintiffs shall suffer irreparable loss, in case the interim relief as prayed for, was not injections are one of the many latest generation immunotherapy drugs also known as checkpoint inhibitors increasingly used to treat several types of cancers including skin, lungs, kidneys, and Hodgkin lymphoma. It works by activating the body's T-cells or immune cells by targeting a protein called PD-1, thereby unleashing an attack on the cancer vials are sold in India for roughly '2 lakh but for patients who are part of the company's assistance or access programs, the drug is available at a slab-wise discounted the India data is not available, globally Bristol Myers Squibb recorded Opdivo sales of $9.3 billion in 2024. Indian companies have launched biosimilars at half the cost of those charged by their global in Indian patent laws told ET that the court has taken a view that stockpiling of a product during its active patent life amounts to infringement and to release it or flood the market is not legally valid."This opinion may have implications for the other ongoing disputes like the weight-loss drug semaglutide (branded Wegovy) case between Novo Nordisk and Dr. Reddy's Labs or Roche versus Natco for Risdiplam (drug used for a rare disease called spinal muscular atrophy or SMA) case," a senior lawyer petition from BMS noted that Zydus Lifesciences was conducting clinical trials for nivolumab and on its investigation found that the company had plans to launch it during the patent period. The Indian company, it said, had applied for a marketing approval with the central drug regulatory its part, lawyers on behalf of Zydus defended saying its product ZRC-3276 does not infringe upon the existing patents and is following the regulatory was represented by a battery of top lawyers including Harish Salve, Dushyant Dave, and Rajiv Nayar, while Squibb & Sons was represented by Sandeep Sethi, PS Raman, Amit Sibal and Pravin Anand, among others.
