Wockhardt Share Price Surge Over 18% Following US FDA Acceptance of Zaynich NDA

Wockhardt Ltd. has seen its shares jumps over 18% following the US Food and Drug Administration's acceptance of its New Drug Application for Zaynich, a novel antibiotic.  

This development signifies a significant achievement for the Indian pharmaceutical industry, marking the first time an Indian company has had an NDA for a New Chemical Entity accepted by the US FDA. 

US FDA's Acceptance of Zaynich NDA 

On December 1, 2025, Wockhardt announced that the US FDA had formally accepted its NDA for Zaynich, a groundbreaking antibiotic aimed at combating resistant bacterial infections. The application, submitted on September 30, represents a historic moment for Indian pharma, traditionally known for generics, as it steps into innovative drug discovery. 

Zaynich is designed to tackle the growing challenge of antimicrobial resistance, an area with limited global innovation. The acceptance of the NDA is a crucial step in the drug's approval process, reflecting the scientific strength and potential impact of Zaynich. 

Company Statement 

As per exchange filings, 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.” 

Read More: Glenmark Pharma Share Price Gains 2% After US FDA Issues Positive Inspection Report! 

Wockhardt Share Price Performance 

As of December 1, 2025, at 2:02 PM, Wockhardt share price on NSE was trading at ₹1,459 up by 18.14% from the previous closing price. 

Conclusion 

Wockhardt's recent success with Zaynich's NDA acceptance by the US FDA marks a pivotal moment for the company and the Indian pharmaceutical industry. This development highlights the potential for Indian companies to innovate in the global pharmaceutical landscape. 

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