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Wockhardt’s Zaynich, a new antibiotic, gained FDA acceptance, boosting shares and marking a historic milestone for India’s pharma industry.
Wockhardt's shares rose nearly 19% on December 1, 2025, after the U.S. FDA accepted its New Drug Application for Zaynich, a first-in-class antibiotic for treating resistant bacterial infections.
The application, submitted September 30, 2025, marks the first FDA acceptance of a New Chemical Entity from an Indian company, highlighting a major milestone for India’s pharmaceutical sector.
Zaynich received fast-track designation, underscoring its potential to address serious unmet medical needs.
The approval reflects high regulatory and scientific standards and boosted investor confidence.
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Wockhardt's Zaynich, un nuevo antibiótico, obtuvo la aceptación de la FDA, impulsando las acciones y marcando un hito histórico para la industria farmacéutica de la India.