Stability Testing for FDA Approved KSHNO14 (Pyridostigmine Bromide Extend – Release Tablets)

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.