The NDA, originally filed on September 30, 2025, marks the first time an Indian pharmaceutical company has had an NDA for a New Chemical Entity accepted by the US FDA—a historic moment for the company.
The company said the acceptance reflects one of the most demanding scientific and regulatory validations in global drug development, requiring extensive clinical data, advanced manufacturing standards, and strict compliance frameworks.
Zaynich, which has been granted Fast Track designation, is now set for priority review by the US FDA. The antibiotic works on a novel β-lactam enhancer mechanism and has drawn international interest for its strong efficacy against highly resistant Gram-negative pathogens—bacteria linked to severe infections, long hospital stays, and high mortality. Its potential has already been demonstrated through compassionate-use cases in critically ill patients in both India and the United States.
Over the last decade, Zaynich has become one of the most extensively researched antibiotics globally, supported by a development program Wockhardt began in 2011. The company has successfully cleared an intensive non-clinical, clinical, and regulatory pathway to reach this stage.
Calling the acceptance a historic achievement, Wockhardt said: “The FDA’s acceptance of the Zaynich NDA is a proud moment and reaffirms our commitment to developing advanced anti-infective solutions for the world and demonstrates what Indian science and innovation can achieve on the global stage.”
Wockhardt has given over 250% returns in the last 5 years.
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