Wockhardt Ltd. has achieved a historic milestone with the United States Food and Drug Administration formally accepting the New Drug Application for its pioneering antibiotic, Zaynich. Filed on 30 September 2025, the NDA’s acceptance marks a turning point for both the company and the Indian pharmaceutical sector, as this is the first time an Indian pharma company has filed and secured acceptance of an NDA for a New Chemical Entity.
The acceptance of an NDA by the US FDA reflects one of the highest global scientific and regulatory benchmarks. It requires strong clinical evidence, advanced manufacturing capabilities, and strict compliance with international standards. Wockhardt’s progress showcases the company’s research strength, innovation focus and commitment to world-class drug development.
Zaynich has already received Fast Track designation from the US FDA, a recognition reserved for therapies with the potential to meet urgent and unmet medical needs. With this designation in place, the FDA will prioritise its review process, accelerating the path toward potential approval.
What makes Zaynich particularly noteworthy is its novel β-lactam enhancer mechanism, a feature that has captured global interest for its effectiveness against highly resistant Gram-negative bacteria. These pathogens are responsible for extended hospital stays and severe health complications worldwide. The drug’s impact has been evident through compassionate-use cases in both India and the United States, where it has shown life-saving potential in critically ill patients.
The development of Zaynich has been one of the most comprehensive antibiotic research programmes undertaken globally. Initiated in 2011, the molecule has undergone an extensive non-clinical, clinical and regulatory evaluation over more than a decade. Wockhardt’s ability to successfully move such a complex molecule through every stage of development demonstrates the company’s scientific capabilities and long-term commitment to combating antimicrobial resistance.
