The purpose of this requirement is to contract for API and Diluent
Awarded Limited / Sole Source Justification Posted
- Solicitation number
- 140D0425Q0704
- Agency
-
Interior Business Center
Office of Policy Management and Budget, Department of the Interior
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- 140D0425P0205 Federal contract award
- Awardee
- Mriglobal
- NAICS code
- 325412 Pharmaceutical Preparation Manufacturing
- PSC
- Q301 Reference Laboratory Testing
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of the Interior's Interior Business Center has issued a sole source justification notice on behalf of the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS) to contract for the manufacture of API (Active Pharmaceutical Ingredient) and diluent for the investigational drug 2R,6R-Hydroxynorketamine, a ketamine metabolite intended for Phase 2 clinical trials. The comprehensive contract encompasses drug substance requalification, production of not more than 700 vials of drug product and diluent, analytical release testing, and a 24-month stability assessment program. MRIGlobal has been selected as the sole source provider due to their unique expertise and prior experience, having previously manufactured this drug product three times with FDA approval and possessing specialized knowledge of the complex manufacturing requirements that no other provider can replicate without significant additional costs and delays. The justification notes that an alternative manufacturer would require approximately $700,000 and six additional months to create an "engineering batch" to understand the drug's specific characteristics. While the total contract value is redacted, the award was posted on September 16, 2025, supporting NIH's Intramural Research Program's efforts to develop a potential new therapy for mental health disorders that aims to be safe and free of misuse and addiction-related side effects.
Notice text
The purpose of this requirement is to contract for API and Diluent
Files
| File | Type | Posted |
|---|---|---|
| A17_JA_-_Redacted_1.pdf |
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