NRx Pharmaceuticals (Nasdaq:NRXP) Announces Completion of Manufacturing Process Validation and Two-Year Stability of Preservative-Free Ketamine
NRx Pharmaceuticals completed Process Validation for three commercial lots of preservative-free ketamine under FDA GMP, ahead of the November 10, 2026 GDUFA goal date for its ANDA. The company also completed two-year real-time room-temperature stability analysis showing no deterioration in purity, potency, or sterility, which it believes supports a labeled shelf life of three years or longer without toxic preservatives.
Key figures
- Drug Name
- Preservative-Free Ketamine (NRX-100)
- Stability data
- two-year real-time room-temperature, projected shelf life of three years or longer
- Gdufa goal date
- 2026-11-10
- Validation lots
- 3
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