Tender Details

Country: USA
Summary: Intramuscular Injectable Generic Analgesic Ketamine for use in an FDA Approved Emergency Use Authorization
UST Ref No: 106901307
Deadline: 07 Oct 2024
Financier: Self Financed
Purchaser Ownership: Government
Tender Value: Refer Document
Notice Type: Tender
Document Ref. No.: HT9425-24-RFI-TJK3
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Description:
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.
Documents:

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Intramuscular Injectable Generic Analgesic Ketamine for use in an FDA Approved Emergency Use Authorization - USA Tender

The DEPT OF DEFENSE | DEFENSE HEALTH AGENCY (DHA), a Government sector organization in USA, has announced a new tender for Intramuscular Injectable Generic Analgesic Ketamine for use in an FDA Approved Emergency Use Authorization. This tender is published on USARFP under UST Ref No: 106901307 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2024-10-07.

The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.