# NRx Pharmaceuticals (Nasdaq:NRXP) Announces Initiation of Commercial Manufacturing for Preservative Free Ketamine

- URL: https://theranews.net/blog/2026-05-05-nrx-pharmaceuticals-nasdaqnrxp-announces-initiation-of-commercial-manufacturing-546cb7/
- Published: 2026-05-05
- Type: Archive summary (AI-assisted summary of third-party reporting)
- Original outlet: globenewswire
- Original report: https://www.globenewswire.com/news-release/2026/05/05/3287507/0/en/NRx-Pharmaceuticals-Nasdaq-NRXP-Announces-Initiation-of-Commercial-Manufacturing-for-Preservative-Free-Ketamine.html
- Topics: depression
- Publisher: TheraNews, operated by AdvancedCare USA Inc.
- Notice: Educational content, not medical, legal, billing or financial advice. Cite the original outlet, not this summary.

> NRXP is manufacturing and commercializing preservative free ketamine.

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NRx Pharmaceuticals has initiated commercial manufacturing of its preservative-free ketamine product in anticipation of approval under the Generic Drug User Fee Act in Summer 2026. The company transmitted an initial GMP manufacturing order to its US-based manufacturer after completing confirmatory GMP audits.

## Manufacturing Innovation and Advantage

NRx's product is the first US-manufactured preservative-free ketamine presentation. The company manufactures via a blow-fill-seal process that achieves more than 10-fold higher manufacturing throughput than traditional sterile bottling techniques relying on glass vials and traditional seals. NRx's ketamine differs from existing products by not containing Benzethonium Chloride, a known toxic preservative that is no longer allowed in new drugs and cannot even be included in hand cleansers and topical antiseptics according to FDA policy.

## Supply Shortage Context

The manufacturing order follows stability observed in more than 3 manufactured registration batches and the company's successful third-party audit of the manufacturing facility. The company expects initial manufacturing to be sufficient to support significant market penetration in first-year sales and can be readily scaled based on the blow-fill-seal process. As of April 7, 2026, sterile intravenous ketamine remains listed on the American Society of Health-System Pharmacists national drug shortage database, with ongoing supply constraints across multiple manufacturers, including product discontinuations, back orders, and reliance on short-dated inventory.

## Regulatory and Clinical Status

NRX-100 has been awarded Fast Track Designation for the treatment of suicidal ideation in depression, including bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 for treating suicidal ideation in patients with depression, including bipolar depression. Dr. Jonathan Javitt, Chairman and CEO, said: "NRx thanks its manufacturing partner for the care and support invested in this project and looks forward to serving Americans with a safe and convenient US-made ketamine product. We hope to alleviate the supply shortages that have frequently been reported."

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*This article is an AI-assisted summary. All facts and figures are drawn from the original report: [https://www.globenewswire.com/news-release/2026/05/05/3287507/0/en/NRx-Pharmaceuticals-Nasdaq-NRXP-Announces-Initiation-of-Commercial-Manufacturing-for-Preservative-Free-Ketamine.html](https://www.globenewswire.com/news-release/2026/05/05/3287507/0/en/NRx-Pharmaceuticals-Nasdaq-NRXP-Announces-Initiation-of-Commercial-Manufacturing-for-Preservative-Free-Ketamine.html)*