NRx Pharmaceuticals completed three GMP validation lots and two years of room-temperature stability testing for preservative-free ketamine ahead of the 10 November 2026 FDA deadline.

NRx said the three commercial-process lots met GMP requirements, while stability data showed no deterioration in purity, potency or sterility after two years without preservatives. Commercially releasable supply is on hand pending FDA approval of its ANDA, with manufacturing supported by Nephron Pharmaceuticals in South Carolina.