Wockhardt files marketing authorisation application for WCK 5222 with EMA
WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation
WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation
NUFYMCO BLA has been approved by the USFDA
Her journey includes leading HR for large and diverse teams across sales, marketing, corporate functions, and R&D
The company introduced the ExcelSign E12 and E17 modular patient monitors, the Relife 1000 biphasic defibrillator, and a new OT charting software
RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization of the product in the US
The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases
This certification validates the plant’s robust capabilities in manufacturing a wide range of sterile dosage forms
Subscribe To Our Newsletter & Stay Updated