NRx Pharmaceuticals (Nasdaq:NRXP) Announces Completion of Manufacturing Process Validation and Two-Year Stability of Preservative-Free Ketamine
Key Highlights
- ➤NRx completes three commercial Process Validation lots of preservative-free ketamine
- ➤Two-year stability shows no purity, potency, or sterility deterioration at room temperature
- ➤Commercially releasable supply is on hand pending ANDA approval
- ➤Company expects stability data to support a labeled shelf life of three years or longer
Expert Statements
Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals
“Completing Process Validation and reaching two years of room-temperature stability puts NRx in position to supply this drug-shortage product the moment the FDA approves our ANDA.”
Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals
“We thank our partners at Nephron Pharmaceuticals in West Columbia, South Carolina, for helping us show that sterile, preservative-free injectables can be made in America, and we look forward to supplying American hospitals and clinics.”
* In advance of November 10, 2026 GDUFA goal date, three commercial lots of Preservative-Free Ketamine have been successfully manufactured in compliance with “Process Validation” required under FDA “Good Manufacturing Practices” (GMP). * NRx has additionally received two year stability data consistent with projected room-temperature stability to three years and beyond with no need for toxic preservatives. * Commercially-releasable drug supply is now on hand pending ANDA approval for this drug-shortage product. WILMINGTON, N.C., Oct. 19, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, “NRx” or “the Company”), a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA receptor platform for the treatment of central nervous system disorders, today announces completion of three Process Validation lots of preservative free Ketamine produced under commercial conditions in anticipation of the November 10 GDUFA (Generic Drug User Fee Amendments) Goal Date. Process Validation(1) is the final step in the drug manufacturing process required to demonstrate compliance with FDA Good Manufacturing Practices (GMP).
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