Zosano Pharma Completes Site Qualification Batches at Contract Manufacturing Organization as it Prepares for NDA Submission of Qtrypta™
Zosano Pharma Corporation (ZSAN)
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Source: GlobeNewswire
Technical Transfer of manufacturing process to CMO signals commencement of commercial readiness activitiesNDA planned for Q4 2019 FREMONT, Calif., June 18, 2019 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that it has completed manufacturing of site qualification batches at its commercial manufacturing site for Qtrypta, the company’s investigational treatment for migraines in late stage development. These batches are intended to demonstrate the robustness and reproducibility of the manufacturing process which will be included as part of its planned submission of a New Drug Application (NDA) for Qtrypta in the fourth quarter 2019. "The completion of these site qualification batches forms the basis of our commercial manufacturing process in our NDA and illustrates the scalability of the process as we head toward commercialization activities for Qtrypta at Thermo Fischer, in North Carolina,” said Hay
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