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Zosano Pharma Completes Site Qualification Batches for NDA

Tech transfer of manufacturing process to CMO signals commencement of commercial readiness activities

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By: Kristin Brooks

Managing Editor, Contract Pharma

Zosano Pharma Corp. 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 4Q19. “The completion of these site qualification batches forms the basi...

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