Wockhardt's Breakthrough: Zaynich Accepted by US FDA

Wockhardt celebrates a historic milestone as its novel antibiotic Zaynich receives acceptance as a new drug application by the US FDA. This achievement spearheads a significant advancement for both the company and the Indian pharmaceutical industry, highlighting Zaynich's potential to address urgent health needs.

Wockhardt, the Mumbai-based pharmaceutical giant, announced a momentous achievement on Monday as its groundbreaking antibiotic, Zaynich, was granted new drug application (NDA) status by the US Food and Drug Administration (FDA).

This marks a historic first for the Indian pharmaceutical sector, as never before has a new chemical entity from an Indian company reached this prestigious milestone in the US. The application, filed on September 30, 2025, signifies a transformative moment for Wockhardt.

The NDA status of Zaynich, coupled with USFDA fast-track designation, underscores the drug's potential to meet pressing and unmet medical needs. Consequently, Wockhardt shares soared by 18.93% on the BSE, trading at Rs 1,467 each.

(With inputs from agencies.)