Wockhardt Zaynich® Gets CDSCO SEC Favourable Recommendation

CDSCO's Subject Expert Committee granted a favourable recommendation for marketing permission of Wockhardt's novel antibiotic Zaynich® (Zidebactam/Cefepime) for Gram-negative infections.
Zaynich® demonstrated superiority over meropenem in Phase 3 (530 patients, 64 sites) and over 97% efficacy in a real-world study across 15 Indian tertiary care hospitals.
NDA (US) and MAA (EU) for Zidebactam/Cefepime are already submitted and in advanced stages of review, signalling near-term global commercialisation potential.
Wockhardt holds a portfolio of 6 antibiotic products, all granted Qualified Infectious Disease Product (QIDP) status by the US FDA, built over 25 years of drug discovery.