WILMINGTON, DE \u2014 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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
The goal date represents the agency\u2019s target for completing its review, not a guarantee of approval.<\/p>\n
NRx said the validation batches demonstrate that its manufacturing process can consistently produce the injectable drug under commercial conditions.<\/p>\n
The company is working with Nephron Pharmaceuticals, based in West Columbia, South Carolina, on production of the preservative-free formulation.<\/p>\n
Separately, NRx reported completing an analysis of two years of real-time stability data showing no deterioration in the product\u2019s purity, potency or sterility when stored at room temperature.<\/p>\n
The findings support the company\u2019s 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.<\/p>\n
The formulation is designed to eliminate the need for preservatives while maintaining the drug\u2019s stability during storage.<\/p>\n
Jonathan Javitt, NRx\u2019s chairman and chief executive officer, said the manufacturing and stability results leave the company prepared to supply the product following approval.<\/p>\n
\u201cCompleting 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,\u201d Javitt said.<\/p>\n
The company has identified hospitals and clinics as its intended customers for the injectable product.<\/p>\n
NRx, a clinical-stage biopharmaceutical company developing treatments for central nervous system disorders, is pursuing the ketamine application alongside its broader drug development activities.<\/p>\n
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.<\/p>\n
The November 10 regulatory goal date is the next scheduled milestone for the product.<\/p>\n