The recommendation clears the path for final approval by the Drugs Controller General of India.
The recommendation follows a comprehensive evaluation of the drug’s clinical dossier, including nine phase-1 studies, a phase-2 study in meropenem-resistant infections, and a global phase-3 trial in complicated urinary tract infections and acute pyelonephritis, along with data from compassionate-use cases.
In the phase-3 study, zidebactam/cefepime demonstrated superiority over meropenem in combined clinical and microbiological cure, indicating strong efficacy against resistant pathogens.
Zaynich is based on a novel beta-lactam enhancer mechanism targeting MDR/XDR gram-negative bacteria, addressing a critical unmet need in anti-infective therapy.
The asset has been developed over 15 years and is supported by a large body of clinical and real-world evidence, including use in severe infections such as hospital-acquired pneumonia and bloodstream infections.
The company further said that regulatory filings for the product have already been submitted in the United States and European Union and are currently under advanced stages of review.
Wockhardt is a global pharmaceutical and biotechnology company focused on developing innovative anti-infective solutions.
The company's consolidated net profit surged to Rs 59 crore in the quarter ended December 2025 as against Rs 14 crore during the previous quarter ended December 2024. Sales rose 23.16% to Rs 888 crore in Q3 FY26 as compared with Q3 FY25.
The scrip fell 1.05% to currently trade at Rs 1176.60 on the BSE.