US FDA Accepts Wockhardt’s NDA for Novel Antibiotic Zaynich

Originally filed on September 30, 2025, the NDA acceptance marks a milestone not just for Wockhardt but also for the Indian pharmaceutical sector. It is the first time a New Chemical Entity (NCE) from an Indian pharma company has been filed and accepted by the US FDA.

“Submitting an NDA to the US FDA represents one of the most stringent scientific and regulatory benchmarks in global drug development. It requires robust clinical evidence, world-class manufacturing capabilities, and strict compliance across multiple domains,” Wockhardt stated.

Zaynich has also been granted Fast Track designation by the US FDA, highlighting its potential to address urgent and unmet medical needs. Under this pathway, the FDA will prioritize the review of the Zaynich NDA.

A novel β-lactam enhancer mechanism-based antibiotic, Zaynich has drawn international attention for its potent activity against highly resistant Gram-negative pathogens, which contribute to prolonged hospitalizations and significant mortality worldwide. Its life-saving potential has already been demonstrated through compassionate use in critically ill patients in India and the US.

Developed over a decade-long science-driven program initiated in 2011, Zaynich is among the most extensively studied antibiotics globally. Wockhardt has successfully navigated rigorous non-clinical, clinical, and regulatory pathways to reach this stage.

“The FDA’s acceptance of the Zaynich NDA is a historic moment for Wockhardt and for India. It underscores our commitment to developing advanced anti-infective solutions and demonstrates the global potential of Indian science and innovation,” the company added.