- Country: USA
- Summary: Piflufolastat F-18 injection drugs (Pylarify) (Notice of Intent to sole source)
- UST Ref No: 126987914
- Deadline: 29 Sep 2025
- Financier: Self Financed
- Purchaser Ownership: Government
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: NOI-CC-26-000012
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- Description:
- Description
Acquisition Description:
This is a Notice of Intent, not a request for proposal. The National Institute of Health, Clinical Center (NIH-CC) intends to negotiate on an other than full and open competition basis with Progenics Pharmaceuticals Inc.
The National Institute of Health, Clinical Center (NIH-CC)-s has the Nuclear Pharmacy (CC NP) department (collectively “Program”) that purchases and compounds radiopharmaceuticals (radioactive drugs) on a daily basis for life-saving clinical nuclear medicine procedures. This is essential for the NIH Clinical Center to achieve optimal patient care. These radiopharmaceuticals are United States Food and Drug Administration (FDA) approved drugs for use in patients. They are also radioactive materials that are regulated by the United States Nuclear Regulatory Commission (US NRC) through the NIH radioactive material license (RAM) administered by the NIH Radiation Safety Office (RSO). Only RSO certified Nuclear Medicine personnel can order these radiopharmaceuticals directly for patient use. Each radiopharmaceutical is time sensitive because of the rapid radiation decay. Because of their short useful half-lives, they cannot be ordered in advance for storage. They must be properly compounded, dispensed, calibrated and delivered for a specific patient at a specific time on a specific date on a daily basis.
The purpose is to procure compounded piflufolasta F-18 in patient ready unit doses (UDs) from an authorized nuclear pharmacy (Sofie Nuclear Pharmacy) for the use by the NIH Nuclear Medicine, Department of Radiology and Imaging Sciences to diagnose and treat diseases as required by necessary patient care protocols at the NIH Clinical Center. This new radioactive drug is vital to the NIH Clinical Center mission.
Justification:
The product is owned and developed by Lantheus Medical/Progenics Pharmaceuticals (now merged as one company). Sofie Co. has been authorized by Lantheus to manufacture and di... - Documents:
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CLICK HERE TO LOGINPiflufolastat F-18 injection drugs (Pylarify) (Notice of Intent to sole source) - USA Tender
The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | NATIONAL INSTITUTES OF HEALTH, a Government sector organization in USA, has announced a new tender for Piflufolastat F-18 injection drugs (Pylarify) (Notice of Intent to sole source). This tender is published on USARFP under UST Ref No: 126987914 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 2025-09-29.
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.
