Relenza (Zanamivir) Rotadisk, 5 mg

Closed Pre-Solicitation Posted

Solicitation number
RZ-09052025
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
325412 Pharmaceutical Preparation Manufacturing
PSC
6505 Drugs And Biologicals
Place of performance
North Carolina 27701, United States
Points of contact

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR), through its Center for the Strategic National Stockpile (SNS), has issued a notice of intent to award a sole source contract for Relenza (Zanamivir) Rotadisk, 5 mg, an FDA-approved antiviral medication. The procurement is being conducted under FAR 6.302-1 authority for "Only One Responsible Source" as GlaxoSmithKline LLC is currently the sole manufacturer of this specific pharmaceutical product with no relationships to resellers or distributors. The medication is essential for maintaining minimum stockpiling capabilities and responding to public health emergencies, specifically targeting both influenza type A and B viruses through inhalation delivery. The acquisition aims to ensure national emergency preparedness and response capabilities for potential pandemic situations. This pre-solicitation notice was posted on September 5, 2025, with a response deadline of September 20, 2025, though it serves primarily for informational and planning purposes rather than constituting an actual solicitation.

This procurement opportunity does not utilize any set-aside designations and will be awarded as a sole source, firm fixed price contract directly to GlaxoSmithKline LLC, located at 410 Blackwell St., Research Triangle Park, Durham, NC. The contract structure includes substantial quantities with 303,333 packages required for the base year and identical quantities for each of four optional years, potentially totaling 1,516,665 packages over the full five-year period. No specific award values or budget ranges have been disclosed in this notice. The contract falls under NAICS code 325412 (Pharmaceutical Preparation Manufacturing) and PSC code 6505 (Drugs and Biologicals). The procurement timeline spans up to five years with the base year plus four optional years, providing the government with flexibility in meeting long-term strategic stockpile requirements. The sole source justification is based on the absence of any other FDA-approved manufacturers for this specific Relenza formulation.

Notice text

This is a NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT under the authority of FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

The Office of the Administration for Strategic Preparedness and Response (ASPR), Center for the Strategic National Stockpile (SNS) intends to award a sole source firm fixed price contract to:

Manufacturer Name
GlaxoSmithKline LLC

410 Blackwell St. Research Triangle Park

Durham, NC, 27701

The purpose of this acquisition is to provide the United States Government (USG) with a pharmaceutical required to maintain minimum stockpiling capabilities for responding to public health events. Relenza (Zanamivir) Rotadisk, 5 mg are essential for readiness and response to national emergencies. Relenza (Zanamivir) is an antiviral drug that is active against both influenza type A and influenza type B viruses. Zanamivir is given by inhalation only.

The USG has a need to procure Relenza (Zanamivir) Rotadisk, 5 mg, a U.S. Food and Drug Administration (FDA)-approved and commercial pharmaceutical, to be utilized during national public health events.  The USG intends to procure the following: quantity of 303,333 packages of Relenza (Zanamivir) Rotadisk 5 mg for the base year, quantity of 303,333 packages of Relenza (Zanamivir) Rotadisk 5 mg for optional year 1, quantity of 303,333 packages of Relenza (Zanamivir) Rotadisk 5 mg for optional year 2, quantity of 303,333 packages of Relenza (Zanamivir) Rotadisk 5 mg for optional year 3, quantity of 303,333 packages of Relenza (Zanamivir) Rotadisk 5 mg for optional year 4.

GlaxoSmithKline LLC is currently the sole manufacturer of Relenza (Zanamivir) Rotadisk, 5 mg.  They have no relationships with resellers or distributors for this product. There are no other United States FDA-approved manufacturers for Relenza (Zanamivir) Rotadisk, 5 mg. 

This notice is for informational and planning purposes and does not constitute a solicitation. This notice of intent is NOT a request for competitive proposals. A determination by the Government not to compete this procurement based upon response(s) to this notice is solely within the discretion of the Government. Interested parties who believe they possess the capabilities to satisfy this requirement must submit in writing their name, address, telephone number, email, UEI/CAGE code, business size, National Drug Code (NDC), and a statement of capability demonstrating their abilities to meet this requirement. The Government will not be responsible for any costs incurred in responding to this notice. All responses must be received by September 20, 2025, at 3:00 PM Eastern Standard Time. All responses must be in writing and must be sent via email to OSContracting.hhs.gov. Reference Relenza (Zanamivir) Rotadisk, 5 mg Acquisition in the subject line. No other submissions will be accepted.

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