Piflufolastat F-18 injection drugs (Pylarify) from Sofie Co. (Notice of Intent to sole source)
ID: NOI-CC-25-000073Type: Presolicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH - CCBETHESDA, MD, 20892, USA

NAICS

Pharmaceutical Preparation Manufacturing (325412)

PSC

DRUGS AND BIOLOGICALS (6505)
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), intends to negotiate a sole-source contract with Sofie Co. for the procurement of Piflufolastat F-18 injection drugs (Pylarify) essential for clinical nuclear medicine procedures at the NIH Clinical Center. This acquisition aims to secure compounded, patient-ready doses of the radiopharmaceutical, which is critical for diagnosing and treating diseases in accordance with patient care protocols. The drugs are FDA-approved and must be compounded and delivered on a time-sensitive basis due to their rapid radiation decay, making Sofie Co. the only authorized provider capable of meeting these specialized requirements. Interested parties may submit capability statements by September 18, 2024, to Lu Chang at lu-chang.lu@nih.gov, as this is not a request for proposals.

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