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( As on 01/12/2025 13:47)

Wockhardt’s Novel Antibiotic ‘Zaynich’ Gets USFDA NDA Acceptance

Wockhardt on Monday announced that the US Food and Drug Administration has accepted the New Drug Application (NDA) for its breakthrough, first-in-class antibiotic Zaynich.

Filed on September 30, 2025, the NDA marks a historic milestone—not just for Wockhardt but for the entire Indian pharmaceutical sector. According to the company, this is the first-ever NDA for a New Chemical Entity (NCE) from an Indian pharma company to be filed and accepted by the USFDA.

Wockhardt called the acceptance a transformative achievement that highlights India’s growing innovation capabilities in global drug discovery and development.