Drug firm Wockhardt said on Monday that the US health regulator has accepted the new drug application (NDA) status for its novel, first-in-class antibiotic Zaynich.
The NDA was filed on September 30, 2025, and its acceptance marks a transformative moment, not only for Wockhardt, but also for the entire Indian pharmaceutical industry, the Mumbai-based drug maker said in a statement.
"This is the first time in history that an NDA for a new chemical entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the US FDA," it added.
Submitting an NDA to the US FDA represents one of the most stringent scientific and regulatory thresholds in global drug development, the company said. Zaynich has been granted fast-track designation by the USFDA, recognising its potential to address urgent and unmet medical needs, it said.
Meanwhile, Wockhardt shares traded 18.93 per cent higher at Rs 1,467 apiece on the BSE.
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