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Drug firm Wockhardt on Wednesday said it has submitted a new drug application for its novel antibacterial drug with the US health regulator. The company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (USFDA) for its novel antibacterial agent Zidebactam-Cefepime injection, the Mumbai-based drugmaker said in a regulatory filing. 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), it added. In the US and EU, more than 8 million cases of cUTI are reported every year, reflecting the global burden of Gram-negative infections, the drug firm stated. "This milestone marks the first-ever NDA submission to the US FDA for a drug, fully discovered and developed by an Indian pharmaceutical company, a momentous achievement for Indian innovation," Wockhardt Ltd said. The NDA submission follows
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.