Wockhardt shares zoom 20% on this USFDA approval
In an exchange filing, Wockhardt said: "The NDA was originally filed on September 30, 2025, and its acceptance marks a transformative moment -- not only for Wockhardt, but also for the entire Indian pharmaceutical industry."
- Dec 1, 2025,
- Updated Dec 1, 2025 2:42 PM IST
Shares of Wockhardt Ltd soared 20 per cent in Monday's trade to hit a high of Rs 1,480.25 after the pharma company announced that the United States Food and Drug Administration (USFDA) has formally accepted the New Drug Application (NDA) for its novel, first-in-class antibiotic Zaynich.
In an exchange filing, Wockhardt said: "The NDA was originally filed on September 30, 2025, and its acceptance marks a transformative moment -- not only for Wockhardt, but also for the entire Indian pharmaceutical industry. 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 USFDA."
The company emphasised the significance of the regulatory milestone, adding: "Submitting an NDA to the USFDA represents one of the most stringent scientific and regulatory thresholds in global drug development. It demands robust clinical evidence, world-class manufacturing capabilities, and rigorous compliance across multidisciplinary domains. Wockhardt's achievement underscores the organisation's scientific depth, innovation strength, and global-standard development excellence."
Wockhardt also highlighted the drug's regulatory momentum, stating: "Zaynich has been granted Fast Track designation by the USFDA, recognising its potential to address urgent and unmet medical needs. As part of this pathway, the FDA has committed to assign priority to Zaynich NDA review."
The company noted the extensive research and development behind the antibiotic: "Over the past decade, Zaynich has become one of the most extensively studied antibiotics globally, reflecting a comprehensive, science-driven development program initiated by Wockhardt in 2011. The company has successfully navigated a demanding non-clinical, clinical and regulatory pathway."
Shares of Wockhardt Ltd soared 20 per cent in Monday's trade to hit a high of Rs 1,480.25 after the pharma company announced that the United States Food and Drug Administration (USFDA) has formally accepted the New Drug Application (NDA) for its novel, first-in-class antibiotic Zaynich.
In an exchange filing, Wockhardt said: "The NDA was originally filed on September 30, 2025, and its acceptance marks a transformative moment -- not only for Wockhardt, but also for the entire Indian pharmaceutical industry. 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 USFDA."
The company emphasised the significance of the regulatory milestone, adding: "Submitting an NDA to the USFDA represents one of the most stringent scientific and regulatory thresholds in global drug development. It demands robust clinical evidence, world-class manufacturing capabilities, and rigorous compliance across multidisciplinary domains. Wockhardt's achievement underscores the organisation's scientific depth, innovation strength, and global-standard development excellence."
Wockhardt also highlighted the drug's regulatory momentum, stating: "Zaynich has been granted Fast Track designation by the USFDA, recognising its potential to address urgent and unmet medical needs. As part of this pathway, the FDA has committed to assign priority to Zaynich NDA review."
The company noted the extensive research and development behind the antibiotic: "Over the past decade, Zaynich has become one of the most extensively studied antibiotics globally, reflecting a comprehensive, science-driven development program initiated by Wockhardt in 2011. The company has successfully navigated a demanding non-clinical, clinical and regulatory pathway."