The U.S. Food and Drug Administration (FDA) has accepted Wockhardt’s New Drug Application (NDA) for its novel antibiotic, Zaynich. This marks the first NDA acceptance for a New Chemical Entity (NCE) from an Indian pharmaceutical company. Zaynich, with its Fast Track designation, targets resistant Gram-negative pathogens and has demonstrated life-saving impact in compassionate use cases in both India and the United States.
Historic Milestone for Indian Pharma
Wockhardt Ltd. announced that the United States Food and Drug Administration (US FDA) has accepted the New Drug Application (NDA) for Zaynich. The NDA was initially filed on September 30, 2025. This achievement marks a turning point for Wockhardt and the Indian pharmaceutical sector, representing the first NDA acceptance for a New Chemical Entity (NCE) from an Indian pharmaceutical company.
Zaynich: Addressing Critical Unmet Needs
Zaynich, a novel antibiotic, has been granted Fast Track designation by the US FDA, highlighting its potential to address urgent and unmet medical needs. This designation reflects the FDA’s commitment to prioritizing the review of the Zaynich NDA. The drug is designed to combat resistant Gram-negative pathogens, which are responsible for significant mortality worldwide. Compassionate use cases have demonstrated the life-saving potential of Zaynich for critically ill patients in both India and the United States.
Extensive Development and Global Impact
Over the past decade, Zaynich has been extensively studied, reflecting a science-driven development program initiated by Wockhardt in 2011. The acceptance of the Zaynich NDA is viewed as a historic and proud moment, reaffirming the company’s commitment to developing advanced anti-infective solutions for global healthcare.
Wockhardt’s Focus
Wockhardt remains dedicated to delivering path-breaking anti-infective therapies to combat serious threats in global healthcare and pioneering next-generation therapies for a healthier world.
Source: BSE
