Wockhardt shares moved higher by 19 per cent, to ₹1,472.70 on the National Stock Exchange (NSE) in Monday’s intraday trade, amid heavy volumes after the company said the United States Food and Drug Administration (USFDA) has formally accepted the New Drug Application (NDA) for its first-in-class antibiotic ‘Zaynich’.
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The stock price of the pharmaceutical company bounced back 20 per cent from its intraday low of ₹1,225.20. Average trading volume on the counter jumped over 10-fold, with a combined 7.76 million equity shares changing hands on the NSE and BSE. In comparison, the Nifty 50 was down 0.08 per cent at 26,181 at 01:05 PM.
Drug firm Wockhardt on Monday said 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 added.
Wockhardt shares were trading 18.93 per cent higher at Rs 1,467 apiece on the BSE.
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