Wockhardt's Zaynich Wins US FDA NDA Nod, Marking a Landmark Moment

Wockhardt Ltd. has made industry history today as the US FDA formally accepted its New Drug Application for Zaynich, marking the first time an Indian pharmaceutical company has achieved NDA acceptance for a New Chemical Entity.

Filed on September 30, 2025, this move places Indian drug development on a new global footing and signals a major shift in how the world views India’s scientific capability.

The acceptance reflects Wockhardt’s success in meeting some of the toughest standards in modern drug development. An NDA demands solid clinical proof, precision manufacturing, and strict regulatory discipline. By crossing this line, the company has shown it can operate at the highest international benchmark.

Also Read: India's Hospitals Face Rising Risk of U.S.-Style Fee-for-Service

Zaynich, based on a novel β-lactam enhancer mechanism, has been under global watch for its strong performance against highly resistant Gram-negative pathogens—organisms that drive severe infections and high hospital mortality. Its promise is further strengthened by the US FDA granting Fast Track designation, which ensures a priority review of the submission.

The antibiotic has already shown life-saving potential through compassionate use in critically ill patients in both India and the United States. Over the past decade, it has grown into one of the most deeply studied antibiotics worldwide, backed by a development program Wockhardt began in 2011 and carried through a demanding research and regulatory pathway.

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."