Wockhardt has secured Central Drugs Standard Control Organisation’s (CDSCO) authorization to import and market its indigenously discovered and developed, first-in-class breakthrough antibiotic, Zaynich (Zidebactam / Cefepime) in India. The approval is for the treatment of adult patients (≥18 years) with complicated urinary tract infections (cUTI), including pyelonephritis, as well as cases with concurrent Gram-negative bacteremia.
Zaynich has emerged as a life-saving therapeutic option, particularly in carbapenem-resistant infections where current treatment options such as colistin and polymyxins are limited by significant toxicity and suboptimal efficacy. Importantly, Zaynich is uniquely positioned to address metallo-β-lactamase (MBL)-mediated resistance, one of the most prevalent and challenging resistance mechanisms in India.
In recognition of its broad-spectrum potential, the Clinical and Laboratory Standards Institute has assigned Cefepime/Zidebactam an investigational susceptible breakpoint of 64 mg/L, supporting its potential to cover clinically important extensively drug-resistant (XDR) Gram-negative pathogens in critically ill patients.
Wockhardt is a research based Global Pharmaceutical and Biotech company.
