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DEPT OF DEFENSE | DEFENSE HEALTH AGENCY (DHA) has floated a tender for Intramuscular Injectable Generic Analgesic Ketamine for use in an FDA Approved Emergency Use Authorization. The project location is USA and the tender is closing on 07 Oct 2024. The tender notice number is HT9425-24-RFI-TJK3, while the TOT Ref Number is 106901307. Bidders can have further information about the Tender and can request the complete Tender document by Registering on the site.
Procurement Summary
Country : USA
Summary : Intramuscular Injectable Generic Analgesic Ketamine for use in an FDA Approved Emergency Use Authorization
Deadline : 07 Oct 2024
Other Information
Notice Type : Tender
TOT Ref.No.: 106901307
Document Ref. No. : HT9425-24-RFI-TJK3
Financier : Self Financed
Purchaser Ownership : Public
Tender Value : Refer Document
Purchaser's Detail
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Description
The purpose of this RFI is to address the USAMMDA WPAC requirement for the development of analgesics for acute severe pain associated with battlefield injuries. The WPAC PMO of USAMMDA is conducting market research to determine the feasibility of securing a manufacturer for the procurement of generic ready-to-inject ketamine for intramuscular injection (IM) for analgesia. No other route of ketamine administration or combination product(s), including autoinjectors, will be considered. In addition, the injectable ketamine must be available for immediate purchase from the open market. The generic ketamine will be used to gain an FDA approved Emergency Use Authorization (EUA) for analgesic ketamine with a subsequent proposed label indication for acute pain via the 505(b)(2) pathway. The sponsor for the EUA will be the Department of Defense (DoD). The analgesic ketamine EUA will allow the DoD to formulate policies on analgesic ketamine use which is expected to result in a large demand for ketamine throughout the Joint Service Military Health System.
Active Contract Opportunity
Notice ID : HT9425-24-RFI-TJK3
Related Notice
Department/Ind. Agency : DEPT OF DEFENSE
Sub-tier : DEFENSE HEALTH AGENCY (DHA)
Office: ARMY MED RES ACQ ACTIVITY
General Information
Contract Opportunity Type: Sources Sought (Original)
All Dates/Times are: (UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA
Original Published Date: Sep 06, 2024 01:33 pm EDT
Original Response Date: Oct 07, 2024 05:00 pm EDT
Inactive Policy: 15 days after response date
Original Inactive Date: Oct 22, 2024
Initiative: None
Classification
Original Set Aside:
Product Service Code: AN13 - HEALTH R&D SERVICES; HEALTH CARE SERVICES; ExPERIMENTAL DEVELOPMENT
NAICS Code: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
Place of Performance: Frederick, MD 21702 USA
Documents
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