Xspray Pharma announces that the FDA has successfully conducted a Pre-Approval Inspection (PAI) of the company's manufacturing lines at a contract manufacturer. The manufacturing of Dasynoc meets all requirements according to cGMP standards. The company has also revised the tablet strengths after dialogue with the FDA to reduce the risk of medication errors. These measures reduce regulatory uncertainty ahead of the PDUFA date on October 7.
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Published June 30, 2025
Xspray Pharma passes FDA inspection for Dasynoc
Notes
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