Mumbai: Wockhardt Ltd. has achieved a historic milestone as the United States Food and Drug Administration (US FDA) formally accepted its New Drug Application (NDA) for Zaynich, a novel, first-in-class antibiotic. This marks the first-ever NDA acceptance for a New Chemical Entity (NCE) from an Indian pharmaceutical company, underscoring India’s growing stature in global drug innovation.
The NDA, filed on September 30, 2025, represents one of the most rigorous scientific and regulatory thresholds in drug development. Acceptance by the US FDA highlights Wockhardt’s robust clinical evidence, advanced manufacturing capabilities, and compliance with global standards.
Key Highlights Of Zaynich’s Breakthrough
- Fast Track Designation: Granted by the US FDA, ensuring priority review due to urgent medical need.
- Novel Mechanism: A β-lactam enhancer with potent activity against highly resistant Gram-negative pathogens.
- Global Impact: Demonstrated life-saving efficacy through compassionate use in critically ill patients in India and the US.
- Extensive Research: Over a decade of comprehensive non-clinical, clinical, and regulatory studies since 2011.
Zaynich has garnered international attention for its ability to combat pathogens responsible for prolonged hospitalizations and high mortality rates worldwide. Its acceptance signals a transformative moment for Wockhardt and the Indian pharmaceutical industry, paving the way for India’s entry into the global league of breakthrough drug developers.
Commenting on the milestone, Wockhardt stated: “The FDA’s acceptance of the Zaynich NDA is a historic and proud moment for the organization and for India. It 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.”
With Zaynich, Wockhardt continues to advance its mission of delivering path-breaking anti-infective therapies to address some of the most serious threats in global healthcare.
