Attachment2__Artesunate for Injection.doc

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USAMMDA ARTESUNATE FOR INJECTION Sources Sought
Solicitation number
W81XWH21IJ43021
Issued by

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This request for information (RFI) seeks responses from qualified sources to provide Artesunate for Injection to treat severe malaria. Responses are due no later than May 12, 2021 and should include completed Attachments 1 and 2 indicating if the product meets the requirements specified. The requirements include that the product must be FDA approved to treat severe malaria in adults and pediatric patients, meet or exceed the performance of the item currently stocked under National Stock Number 6505-01-691-9092 or 6505-01-691-9064, and be supplied in either a package of four vials of the drug and four vials of diluent or a package of two vials of the drug and two vials of diluent. The U.S. Army Medical Command requires a total of 104 vials of Artesunate for Injection to be shipped to specified military treatment facilities for use in treating severe malaria cases. Responses to this RFI will be treated as confidential business information and will aid in planning for potential future procurement of this medical item.

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Attachment 2.

The requirements listed in the table below shall be accommodated by the responder offering Artesunate for Injection. Please indicate Y (yes) or N (No) if your product meets each requirement in the requirements list below, and use the comments column to further justify how your product meets the requirement.

REQUIREMENTS/ SPECIFICATIONS

Meets Requirement?

(Y/N) Comments

1
Shall be FDA approved and indicated for the initial treatment of severe malaria in adults and pediatric patients.
2
Shall meet or exceed the performance of Artesunate for Injection (National Stock Number (NSN) 6505-01-691-9092 or 6505-01-691-9064) for treatment of severe malaria.
3
a. The unit of issue/unit of purchase (UI/UP) shall be either of the following:

· A package consisting of four vials of Artesunate for Injection (each vial containing 110 mg of the active pharmaceutical ingredient) and four vials of the phosphate buffer solution (each vial containing 12 milliliters of the phosphate buffer diluent). This “4x4” configuration has a single NSN of 6505-01-691-9092. Twenty-six packages of this configuration will satisfy the USAMMDA requirement.

· A package consisting of two vials or Artesunate for Injection (each vial containing 110 mg of the active pharmaceutical ingredient) and two vials of the phosphate buffer solution (each vial containing 12 milliliters of the phosphate buffer diluent). This “2x2” configuration has a single NSN of 6505-01-691-9064. Fifty-two packages of this configuration will satisfy the USAMMDA requirement

(End)

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