Wockhardt Ltd has secured FDA acceptance of its NDA for antibiotic Zaynich, the first New Chemical Entity from an Indian pharma company. With Fast Track status, Zaynich targets resistant Gram-negative pathogens and has shown life-saving results. The milestone marks a historic leap for India in global pharmaceutical innovation.
Wockhardt Ltd has achieved a landmark milestone with the U.S. Food and Drug Administration (FDA) formally accepting its New Drug Application (NDA) for the novel antibiotic Zaynich. Filed on September 30, 2025, this acceptance marks the first-ever NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company, positioning Wockhardt at the forefront of global pharma innovation.
Key highlights of the development:
Zaynich has been granted Fast Track designation, targeting multi-drug resistant Gram-negative pathogens, a critical area in global healthcare.
The drug has already demonstrated life-saving impact in compassionate use cases across India and the U.S., particularly for complicated urinary tract infections (cUTIs).
FDA acceptance reflects Wockhardt’s advanced clinical evidence, manufacturing capabilities, and compliance with international standards, setting a new benchmark for Indian pharma.
Industry experts view this as a historic breakthrough, potentially paving the way for a U.S. launch by FY27.
This milestone not only strengthens Wockhardt’s global presence but also underscores India’s growing role in tackling antimicrobial resistance, a pressing global health challenge.
Sources: Business Upturn, InvestyWiseInvestyWise, Moneycontrol