NRx Pharmaceuticals completes manufacturing validation for preservative-free ketamine
NRXP•NRx Pharmaceuticals completed three commercial-scale validation lots for preservative-free ketamine and reported two-year room-temperature stability with no deterioration in purity, potency or sterility. Commercially releasable supply is available pending FDA approval of its abbreviated new drug application, targeted for November 10, 2026.
1. Validation completed
NRx Pharmaceuticals completed three commercial-scale process validation lots that it said meet FDA good manufacturing practice requirements. Two-year room-temperature stability testing showed no deterioration in purity, potency or sterility without preservatives; commercially releasable supply is available pending FDA approval of the abbreviated new drug application, with a November 10, 2026, target date.
