Wockhardt has successfully filed a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for its novel antibiotic, WCK 5222, on 5 January 2026. The EMA is the regulatory authority responsible for the scientific evaluation, of new medicines across the 27 European Union (EU) Member States and three European Economic Area (EEA) countries�Iceland, Liechtenstein, and Norway�covering a total of 30 countries. Earlier, the EMA had informed Wockhardt that WCK 5222, a fixed-dose combination of Zidebactam (1 g) and Cefepime (2 g), is eligible for Accelerated Assessment. This pathway allows for an abridged review timeline, reflecting the unmet medical need addressed by the product. The New Drug Application (NDA) on WCK 5222 is already under fast-track review by the US FDA.Based on the comprehensive clinical and regulatory data included in the application, Wockhardt expects WCK 5222 approval for treatment of resistant Gram negative infections across all countries under the EMA`s jurisdiction. The priority review status granted to WCK 5222 underscores the global urgency to make effective treatment options available for patients suffering from life-threatening multi-drug resistant infections.Notably, WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation. Powered by Capital Market - Live News

The European Medicines Agency (EMA) has informed Wockhardt that WCK 5222 (combination of Zidebactam 1g + Cefepime 2g) is eligible for Accelerated Assessment, following a pre-submission meeting with the EMA review team.The Accelerated Assessment designation reflects EMA��s view that WCK 5222 has the potential to address an unmet medical need by providing an effective therapeutic option for the treatment of following serious and life-threatening infections, particularly those caused by multi-drug-resistant (MDR) and extremely drug resistant (XDR) Gram negative pathogens.Complicated urinary tract infections (cUTI), including pyelonephritis �h Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) �h Complicated intra-abdominal infections (cIAI) �h Treatment of patients with bacteraemia occurring in association with, or suspected to be associated with, cUTI/acute pyelonephritis, HAP/VAP, or cIAI �h Treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment optionsIf approved, the proposed breadth of indications would support the use of WCK 5222 across a wide range of serious infections and contribute to addressing the growing public health challenge of antimicrobial resistance. WCK 5222 represents the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation, reflecting the advancement of an India-initiated global antimicrobial innovation efforts.  Powered by Capital Market - Live News

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