Mumbai: Pharmaceutical major Wockhardt is moving ahead to commercialise its breakthrough drug, Zaynich, offering a hope to millions of patients who require a stronger diagnosis for their ailments. The company has filed a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA), bringing the drug closer to launch in the Eurozone.
Based on its proprietary antibiotic, WCK 5222, the US FDA has accepted Wockhardt’s New Drug Application (NDA) as of December 1, 2025. This development is the biggest achievement by an Indian pharmaceutical company, which has been developing low-cost, ‘copycat’ generic drugs for years, without much innovation. Wockhardt’s NDA is the first filed from India, offering hope to an increasing challenge faced by millions of people- Antibiotic Resistance (AMR).
According to a press release, Wockhardt expects the EMA to approve its MAA soon, based on the comprehensive clinical and regulatory data included in the application. Even the US FDA has been fast-tracking the drug’s review, which is expected to receive final approval this year.
Once done, Zaynich could become one of the few new antibiotics to target AMR, a increasing challenge faced by healthcare professionals as disease-causing pathogens mutate to survive the use of general antibiotics.
Wockhardt has been working on the development of since 2011, even as other large pharmaceutical companies have stepped back from antibiotic research due to high costs and low profits.
Given the urgency of the requirement, Zaynich is expected to boost Wockhardt’s market cap significantly this year, with the supplies of the drug may not meet the demand, going by the urgency shown by the USFDA and other authorities. 2026 could be the year of Zaynich, to put it mildly.
