The aforementioned NDA was filed on 30 September 2025.
'This is the first time in history that an NDA for a new chemical entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the US FDA,” the company said in a statement.
Zaynich has been granted ‘fast track’ designation by the US FDA, recognizing its potential to address urgent and unmet medical needs. As part of this pathway, the FDA has committed to assign priority to Zaynich NDA review.
Zaynich, a β-lactam enhancer, has drawn international interest for its activity against resistant gram-negative bacteria, which are linked to long hospital stays and high mortality. It has been used in critically ill patients in India and the United States.
Wockhardt is a global pharmaceutical and biotechnology company focused on developing anti-infective solutions.
The company had reported a consolidated net profit of Rs 78 crore in Q2 FY26 as against a net loss of Rs 22 crore recorded in Q2 FY25. Net sales declined 3.34% to Rs 782 crore in Q2 FY26 as compared with Q2 FY25.
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