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 patients with concurrent bacteremia, the composite response rate at the test-of-cure visit was 89% for Zaynich, compared with 44% for meropenem, highlighting its potential effectiveness in severe infections.
Before entering Phase 3 trials, the drug was evaluated in nine Phase 1 studies and a Phase 2 trial involving patients with documented meropenem-resistant Gram-negative infections. The Phase 2 study, conducted across 15 tertiary care hospitals in India, reported clinical efficacy of more than 97% across serious infections, including hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, bloodstream infections and complicated intra-abdominal infections.
Wockhardt said Zaynich could address a critical unmet need in the treatment of carbapenem-resistant and extensively drug-resistant Gram-negative infections, particularly those driven by metallo-beta-lactamase (MBL) resistance mechanisms, which are prevalent in India.
The company has also submitted a New Drug Application for Cefepime/Zidebactam in the United States and a Marketing Authorisation Application in the European Union. Both applications are currently under regulatory review. The drug has previously received Priority Review, Fast Track and Qualified Infectious Disease Product (QIDP) designations from the US Food and Drug Administration.
Wockhardt is a research-driven global pharmaceutical and biotechnology company focused on developing anti-infective therapies. The company currently has six antibiotics at various stages of development and commercialisation, all of which have received QIDP designation from the US FDA.
On a consolidated basis, the company reported a net profit of Rs 164 crore in Q4 FY26, reversing a loss of Rs 45 crore in the year-ago period. PAT surged 168.85% QoQ from Rs 61 crore in Q3 FY26. Revenue from operations rose 29.87% YoY to Rs 965 crore in Q4 FY26, while increasing 8.67% QoQ from Rs 888 crore.
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