Wockhardt today announced that the United States Food and Drug Administration (US FDA) has formally accepted the New Drug Application (NDA) for its novel, first-in-class antibiotic Zaynich. The NDA was originally filed on September 30, 2025, and its acceptance marks a transformative moment�not only for Wockhardt, but also for the entire Indian pharmaceutical industry. This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the US FDA. Zaynich has been granted Fast Track designation by the US FDA, recognizing its potential to address urgent and unmet medical needs. As part of this pathway, the FDA has committed to assign priority to Zaynich NDA review.A novel �-lactam enhancer mechanism based Zaynich has garnered international attention for its potent activity against highly resistant Gram-negative pathogens�microbes responsible for prolonged hospitalizations and significant mortality worldwide. Its life-saving impact has already been demonstrated through compassionate use in critically ill patients in both India and the United States.Over the past decade, Zaynich has become one of the most extensively studied antibiotics globally, reflecting a comprehensive, science-driven development program initiated by Wockhardt in 2011. The company has successfully navigated a demanding non-clinical, clinical and regulatory pathway.Powered by Capital Market - Live News

Net profit of Wockhardt reported to Rs 78.00 crore in the quarter ended September 2025 as against net loss of Rs 22.00 crore during the previous quarter ended September 2024. Sales declined 3.34% to Rs 782.00 crore in the quarter ended September 2025 as against Rs 809.00 crore during the previous quarter ended September 2024. ParticularsQuarter EndedSep. 2025Sep. 2024% Var. Sales782.00809.00 -3 OPM %22.7613.60 - PBDT144.0046.00 213 PBT91.00-9.00 LP NP78.00-22.00 LP Powered by Capital Market - Live News

Wockhardt will hold a meeting of the Board of Directors of the Company on 3 November 2025.Powered by Capital Market - Live News

Wockhardt today announced the submission of New Drug Application (NDA) to the U.S. Food and Drug Administration (US FDA) for its novel antibacterial agent Zidebactam-Cefepime injection (WCK 5222, ZAYNICH�). The NDA seeks approval for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, with or without concurrent bacteremia caused by Gram-negative bacteria including multidrug-resistant (MDR). In US and EU, more than 8 Million cUTI cases are reported every year, reflecting the global burden of Gram negative infections.This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company, a momentous achievement for Indian innovation. Amidst the escalating global crisis of antimicrobial resistance (AMR), Zidebactam-Cefepime represents a first-in-class �-lactam enhancer and �-lactam combination, introducing a novel mechanism of action to combat some of the most difficult-to-treat infections particularly those that remain unresponsive to approved antibiotics, including those that are recently approved. Clinical and non-clinical studies have demonstrated its potent activity against multi-drug resistant (MDR) and extreme drug resistant (XDR) Gram-negative pathogens, including those harbouring NDM carbapenemases and PBP mutations. A Phase II study undertaken has demonstrated its efficacy against diverse carbapenem-resistant infections. The NDA submission follows the successful completion of a pivotal Phase III global clinical trial (ENHANCE 1), conducted across 64 sites in India, USA, Bulgaria, Estonia, Lithuania, Poland, Slovakia, Mexico, and China. The program is supported by a robust clinical development package, including nine Phase I studies conducted in the U.S. and China, a Phase II study conducted in India and a multinational Phase III trial evaluating efficacy in cUTI, including pyelonephritis.Zidebactam-cefepime has been granted qualified infectious disease product (QIDP) and Fast Track Designation by US FDA.Gram-negative infections have become increasingly difficult to treat due to wide spread resistance to multiple classes of antibiotics. Zaynich� has the potential to treat a broad range of infections caused by MDR or XDR pathogens including Enterobacterales and Pseudomonas aeruginosa and A. baumannii. Powered by Capital Market - Live News

Wockhardt announced that ICRA has upgraded the credit ratings to BBB/ A3+ and revised the outlook from stable to positive for various debt facilities availed by the company. Powered by Capital Market - Live News