Mumbai, May 29 -- The approval was granted by the Central Drugs Standard Control Organisation (CDSCO) and marks a significant milestone for the company's antibiotic research programme.

Zaynich is an indigenously discovered and developed antibiotic that combines Zidebactam, a beta-lactam enhancer antibiotic, with Cefepime, a cephalosporin antibacterial drug.

The approval is backed by results from the global Phase 3 ENHANCE-1 clinical trial, which compared Zaynich with meropenem in patients suffering from complicated urinary tract infections. The study showed that 89% of patients treated with Zaynich achieved the primary endpoint of clinical cure and microbiological eradication, compared with 68.4% of patients receiving meropenem.

Among ...