The approval marks a landmark moment as it is the first time an Indian pharmaceutical company has had an NDA for a completely new chemical entity accepted by the US regulator. Zaynich, built on a novel β-lactam enhancer mechanism, has also received Fast Track status for its potential to address urgent medical needs. With over a decade of research behind it, the drug has demonstrated strong efficacy against highly resistant Gram-negative pathogens and has already helped critically ill patients in India and the US through compassionate use. The acceptance reflects confidence in Wockhardt's scientific depth and its global-standard development program.

Wockhardt is a global pharmaceutical and biotechnology company focused on developing innovative anti-infective solutions. The company posted a consolidated net profit of Rs 78 crore in Q2 FY26 compared with a net loss of Rs 22 crore a year earlier, while net sales declined 3.34% YoY to Rs 782 crore.