WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) has completed commercial-scale manufacturing validation for its preservative-free injectable ketamine, positioning the company to begin supplying U.S. hospitals and clinics if the Food and Drug Administration approves its generic drug application ahead of a November 10 regulatory target date.
The company said it successfully manufactured three validation batches under commercial production conditions, completing a key manufacturing requirement under FDA current Good Manufacturing Practice standards.
NRx also reported that it has commercially releasable inventory available, subject to regulatory approval, as it prepares to enter a market where ketamine has experienced drug shortages.
The manufacturing milestone comes as the company awaits an FDA decision on its Abbreviated New Drug Application, or ANDA, which has a November 10, 2026, goal date under the Generic Drug User Fee Amendments program.
The goal date represents the agency’s target for completing its review, not a guarantee of approval.
NRx said the validation batches demonstrate that its manufacturing process can consistently produce the injectable drug under commercial conditions.
The company is working with Nephron Pharmaceuticals, based in West Columbia, South Carolina, on production of the preservative-free formulation.
Separately, NRx reported completing an analysis of two years of real-time stability data showing no deterioration in the product’s purity, potency or sterility when stored at room temperature.
The findings support the company’s expectation that the formulation could qualify for a shelf life of three years or longer, although the final approved shelf life remains subject to FDA review.
The formulation is designed to eliminate the need for preservatives while maintaining the drug’s stability during storage.
Jonathan Javitt, NRx’s chairman and chief executive officer, said the manufacturing and stability results leave the company prepared to supply the product following approval.
“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,” Javitt said.
The company has identified hospitals and clinics as its intended customers for the injectable product.
NRx, a clinical-stage biopharmaceutical company developing treatments for central nervous system disorders, is pursuing the ketamine application alongside its broader drug development activities.
The manufacturing work and accumulated inventory reduce certain production-related steps that would otherwise remain before commercialization. However, U.S. distribution cannot begin under the pending application until the FDA grants approval.
The November 10 regulatory goal date is the next scheduled milestone for the product.
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