NRx Pharmaceuticals Completes Three Process Validation Lots Of Preservative Free Ketamine Produced Under Commercial Conditions In Anticipation Of Nov. 10 Generic Drug User Fee Amendments Goal Date

NRx Pharmaceuticals has completed three Process Validation lots of preservative-free Ketamine under commercial conditions, in preparation for the November 10 GDUFA goal date. The company has also analyzed two-year stability data showing no deterioration in purity, potency, or sterility, suggesting a potential shelf life of three years or longer. This completion is a key step in demonstrating compliance with FDA Good Manufacturing Practices.