Wockhardt secures US FDA approval for antibiotic Zaynich

Wockhardt marks research milestone with USFDA approval for novel antibiotic Zaynich

Wockhardt received FDA approval for Zaynich (cefepime + zidebactam), the first New Chemical Entity fully developed by an Indian pharma company to clear FDA, with Phase 3 data showing 89% efficacy vs 68.4% for meropenem in cUTI. The approval targets antimicrobial resistance — a growing clinical and procurement priority — and signals that non-Western pharma R&D pipelines are producing first-in-class assets with credible Phase 3 validation.