Stability Testing for FDA Approved KSHNO14 (Pyridostigmine Bromide Extend – Release Tablets)
Closed Pre-Solicitation Posted
- Solicitation number
- W911SR-26-S-ASPC
- Agency
-
ACC Aberdeen Proving Ground
Army Contracting Command, Department of Defense
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- Maryland 21702, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of the Army Materiel Command Army Contracting Command Aberdeen Proving Ground is conducting market research to identify potential vendors capable of supporting FDA-compliant stability testing for KSHN014 (Pyridostigmine Bromide Extend-Release Tablets) 105 mg. This pre-solicitation notice seeks information on sources that can assume or support long-term stability testing including continuity requirements for an existing ongoing stability study. The stability testing must encompass five years at controlled room temperature (CRT) and ten years under refrigerated storage conditions for tablets manufactured by Amneal Complex Research LLC and packaged in blister pack throughout the in-use period. Key qualifications include the ability to meet full scope technical, regulatory, and continuity requirements associated with the multiyear stability testing effort. Interested vendors must respond by February 19, 2026, as this is the due date for the pre-solicitation notice, though this notice is issued for market research purposes only and does not constitute a solicitation for proposals or result in an award.
No set-aside designation applies to this procurement opportunity. Amneal Complex Research LLC is identified as the incumbent manufacturer of the pyridostigmine bromide tablets subject to stability testing. The notice does not disclose a specific award value or budget range for this contract. The procurement involves supporting an ongoing stability study with multiyear testing requirements, indicating a substantial timeline extending beyond the stated testing periods of five to ten years. This effort falls under NAICS code 541715 (Research and Development in the Physical, Engineering, and Life Sciences) and PSC code AC13 (National Defense R&D Services; Department of Defense - Military; Experimental Development), reflecting its nature as a defense research and development initiative in support of FDA-approved pharmaceutical products.
Notice text
This Sources Sought notice is issued for market research purposes only to identify potential sources capable of supporting FDA compliant stability testing for FDA approved KSHN014 (Pyridostigmine Bromide Extend – Release Tablets) 105 mg tablet for five (5) years at CRT and ten (10) years refrigerated, manufactured by Amneal Complex Research LLC and packaged in Blister Pack throughout the in-use period.
The government is specifically seeking information on vendors capable of assuming or supporting long term stability testing including continued continuity requirements associated with an existing ongoing stability study. This notice is not a solicitation for proposals, and no award will be made as a result of this notice.
CPE CBRN Medical CDP has an ongoing stability study in support of FDA approved KSHN014 (Pyridostigmine Bromide Extend – Release Tablets) 105 mg tablets, the study includes multiyear stability testing including long term and refrigerated storage conditions with stability data.
The government is conducting market research to determine whether there are additional responsible sources capable of meeting the full scope of technical regulatory and continuity requirements associated with this effort.
On GovTribe
Work this opportunity
- Track it in your pipeline
- Find teaming partners
- Similar opportunities
- Ask GovTribe AI about this opportunity