NRx Pharmaceuticals Inc. (NASDAQ: NRXP) has initiated commercial manufacturing for its preservative-free ketamine product following guidance from the FDA Office of Generic Drugs, according to a company statement.

The biopharmaceutical company transmitted an initial GMP manufacturing order to its US-based manufacturer and completed confirmatory GMP audits. The company expects FDA approval under the Generic Drug User Fee Act in summer 2026.

The manufacturing process uses blow-fill-seal technology, which the company states achieves more than 10-fold higher manufacturing throughput compared to traditional sterile bottling techniques using glass vials. The initial manufacturing pace is designed to support substantial first-year revenues, with the ability to scale production based on demand.

NRx's ketamine formulation does not contain Benzethonium Chloride, a preservative found in existing ketamine products. The FDA no longer permits this preservative in new drugs and has restricted its use in hand cleansers and topical antiseptics.

The American Society of Health-System Pharmacists reported ongoing supply constraints for sterile intravenous ketamine as of April 7, 2026, including product discontinuations, back orders, and reliance on short-dated inventory across multiple manufacturers.

"We hope to alleviate the supply shortages that have frequently been reported in association with sterile ketamine," said Dr. Jonathan Javitt, chairman and CEO of NRx Pharmaceuticals.

The company recently appointed Glenn Tyson as Chief Commercial Officer and is assembling a commercial team. NRx focuses on neuroplastic therapies for depression, PTSD, and related conditions.