WILMINGTON, DE — NRx Pharmaceuticals (Nasdaq: NRXP) has placed its first commercial manufacturing order for a preservative-free ketamine product ahead of a potential U.S. approval expected under the Generic Drug User Fee Act process this summer.
The order follows stability testing on more than three registration batches and completion of third-party Good Manufacturing Practice audits at the company’s U.S.-based manufacturing facility. NRx is also preparing for a pre-approval inspection tied to its pending application.
Initial production capacity is intended to support substantial first-year commercial demand, with additional scale available through a blow-fill-seal manufacturing process that the company estimates delivers more than 10 times the throughput of traditional sterile vial bottling methods.
NRx describes the treatment as the first preservative-free ketamine presentation manufactured in the United States.
The formulation excludes Benzethonium Chloride, a preservative the company noted is no longer permitted in newly approved drugs under FDA policy and is also prohibited in hand cleansers and topical antiseptics.
Sterile intravenous ketamine remained listed on the American Society of Health-System Pharmacists national drug shortage database as of April 7.
According to ASHP data referenced by NRx, supply disruptions across existing ketamine manufacturers have included product discontinuations, back orders, and reliance on short-dated inventory, particularly for higher-concentration injectable formulations used in hospital and outpatient settings.
The company recently appointed Glenn Tyson and is assembling a commercial launch team ahead of a potential market rollout.
“We hope to alleviate the supply shortages that have frequently been reported in association with sterile ketamine,” Jonathan Javitt said.
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