Wockhardt seeks DCGI nod for Zaynich
Drugmaker Wockhardt on Friday said that it has filed for regulatory approval of its Zaynich with the Drug Controller General of India (DCGI), with a domestic launch expected in the second half of the current fiscal.
The drugmaker also revealed plans to file New Drug Application (NDA) in USA by August following a successful pre-NDA (non-disclosure agreement) meeting with the US Food and Drug Administration (USFDA). If approved, the company aims for a U.S. launch in FY2026-27.
In addition to India and the U.S., Wockhardt is preparing to seek regulatory approvals in Europe and emerging markets in the second half of the current fiscal year.
The company has an addressable market opportunity of USD 7 billion in the US and Europe.
The outcome of this study reflects the impact of Zaynich’s novel β-lactam enhancer mechanism of action. Additionally, Zaynich was well-tolerated and showed a safety profile consistent with β-lactam class of antibiotics, comparable to meropenem. This study is NDA-enabling, based on which marketing authorization applications will be made to global health authorities including India, US, EMA and MHRA.
