Wockhardt Ltd.

New Delhi: Mumbai-based drugmaker Wockhardt is seeking marketing approval for its novel antibacterial agent Zidebactam-Cefepime branded as 'Zaynich' in the US. In a release the company announced the submission of a New Drug Application (NDA) of Zaynich to the US FDA for the treatment of complicated urinary tract infections (cUTI), caused by bacteremia caused by Gram-negative bacteria including multidrug-resistant (MDR). Zaynich, an antibiotic engineered to treat drug-resistant bacterial infections involves two agents, Cefepime and Zidebactam, which disrupts cell wall formation, and binds a key protein (PBP2) in bacteria essential for their survival. Wockhardt has moved the candidate into the approval stage following the successful completion of Phase III trial (ENHANCE 1), conducted across 64 sites where it demonstrated “over 97 per cent clinical efficacy” in treating seriously ill patients with infections caused by carbapenem-resistant Gram-negative pathogens. The novel antibiotic is completely discovered and developed by Wockhardt, has been granted qualified infectious disease product (QIDP) and FTD from the US FDA. According to the drugmaker, in the US and EU, more than 8 million cUTI cases are reported every year and Gram-negative infections have become increasingly difficult to treat due to widespread resistance to multiple classes of antibiotics. However, with its novel mechanism of action, Zaynich has the potential to treat a broad range of infections caused by multi-drug resistant (MDR) and extreme drug resistant (XDR) pathogens, it added. Notably, the submission comes months after the company had announced to exit the US generics segment to sharpen its focus on its innovative portfolio of “antibiotics and insulin.” The company had filed for voluntary liquidation under Chapter 7 of the US Bankruptcy Code for its step down subsidiaries, Morton Grove Pharmaceuticals Inc. and Wockhardt USA LLC, and the decision is effective from July 11, 2025. By Online Bureau ,

New Delhi: Shukra Pharmaceuticals on Wednesday said it has entered into a strategic non-exclusive Pan-India distribution arrangement with Wockhardt Ltd. The authorization is effective from September 9, 2025 and is valid until March 2026, an exchange filing said. The products include advanced anti-infective formulations and antibiotics developed to combat critical infections. The mandate includes distribution and management of products across all ESIC/ESIS hospitals and Defence/AFMSD/DGAFMS units throughout India, the filing said. "This collaboration further strengthens Shukra Pharmaceuticals presence in institutional and government healthcare networks across India, enhancing revenue visibility and operational footprint," the company said. Shukra Pharmaceuticals Limited is engaged in manufacturing and marketing pharmaceutical products as well as laboratory testing.

New Delhi: Pharmaceuticals firm Wockhardt Ltd on Friday reported a widening of consolidated loss after tax at Rs 108 crore in the June quarter, hit by impairment due to liquidation of subsidiaries in the US after exiting the generics business in the country. The company had posted a consolidated loss after tax of Rs 16 crore in the corresponding quarter last fiscal, Wockhardt Ltd said in a regulatory filing. Consolidated revenue from operations in the quarter was marginally down at Rs 738 crore against Rs 739 crore in the year-ago period, it added. Total expenses in the quarter under review were lower at Rs 770 crore compared to Rs 775 crore in the same period a year ago, the company said. Wockhardt said its management has assessed impairment at CGU (cash generating unit) level, and the related goodwill in the books of account of Rs 97 crore has been impaired as on June 30, 2025, which has been disclosed under exceptional items. It follows the company's decision to exit the US generic pharmaceutical segment and subsequent filing for voluntary liquidation of step-down subsidiaries, Morton Grove Pharmaceuticals Inc. and Wockhardt USA LLC, both incorporated in Delaware, the filing said.