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Wockhardt Limited ( (IN:WOCKPHARMA) ) has provided an announcement.
Wockhardt has filed a Marketing Authorisation Application with the European Medicines Agency for its novel antibiotic WCK 5222, branded as Zaynich, a fixed-dose combination of Zidebactam and Cefepime designed to treat resistant Gram-negative infections. The EMA has deemed the drug eligible for Accelerated Assessment, and Wockhardt expects approval across all EMA countries, complementing fast-track review already under way at the U.S. FDA and filings in India; as the first New Chemical Entity discovered and developed in India to seek pan-European authorisation, the move marks a significant milestone for both the company and the country’s innovation credentials in addressing life-threatening multi-drug resistant infections.
More about Wockhardt Limited
Wockhardt Limited is an India-based pharmaceutical company with a long-standing focus on antibiotic innovation and the treatment of multi-drug resistant infections. Over more than 27 years, it has built a discovery portfolio of six novel antibiotics at various stages of clinical development and commercialization, three of which are already approved for clinical use, with all six granted Qualified Infectious Disease Product designation by the U.S. FDA, underscoring its niche positioning in advanced anti-infective therapies.
Average Trading Volume: 70,875
Technical Sentiment Signal: Strong Buy
Current Market Cap: 236B INR
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