Stability Testing for FDA Approved KSHNO14 (Pyridostigmine Bromide Extend – Release Tablets)
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Department of the Army (W6QK ACC-APG) is conducting market research via a Sources Sought notice to identify potential sources for FDA compliant stability testing for KSHN014 (Pyridostigmine Bromide Extend – Release Tablets) 105 mg. This effort supports an existing ongoing stability study, requiring testing for five (5) years at CRT and ten (10) years refrigerated. Responses are due February 19, 2026.
Scope of Work
The government is seeking vendors capable of providing FDA compliant stability testing for KSHN014 (Pyridostigmine Bromide Extend – Release Tablets) 105 mg, manufactured by Amneal Complex Research LLC and packaged in Blister Pack. The required testing periods are five (5) years at Controlled Room Temperature (CRT) and ten (10) years under refrigerated conditions. A critical aspect is the ability to assume or support long-term stability testing, including continuity requirements associated with an existing ongoing stability study conducted by CPE CBRN Medical CDP. This includes multiyear stability testing with long-term and refrigerated storage conditions and associated data.
Contract & Timeline
- Type: Sources Sought / Market Research
- Set-Aside: None specified
- Response Due: February 19, 2026, 07:00 PM EST
- Published: January 29, 2026, 12:35 PM EST
Evaluation
This notice is issued for market research purposes only to determine if there are additional responsible sources capable of meeting the full scope of technical, regulatory, and continuity requirements for this effort.
Additional Notes
This is not a solicitation for proposals, and no award will be made as a result of this notice. The information gathered will be used for planning purposes.