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Piflufolastat F-18 (Pylarify™) Compounding and Supply

Active

Federal

Response Deadline09/29/2026, 02:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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This subcontract with the National Institutes of Health involves the compounding and supply of Piflufolastat F-18 injection, known as Pylarify, for prime contractors on clinical projects. The selected provider must possess authorized commercial nuclear pharmacy licensing to compound radioactive drugs within clean rooms and hot cells in strict accordance with FDA and NRC regulations. Key responsibilities include ensuring precise activity levels and calibration, performing radiation monitoring, and conducting wipe testing to maintain safety and quality standards. The contractor is required to deliver patient-ready unit doses on demand to the place of performance in Bethesda. This specialized medical supply effort falls under NAICS code 325412 and is managed by the Department of Health and Human Services.

General Info

NIH subcontract for compounding and supplying Pylarify injections to clinical projects in Bethesda.

Agency

Department Of Health And Human Services → National Institutes Of Health - CcView Agency

NAICS

325412 - Pharmaceutical Preparation ManufacturingView NAICS

Place of Performance

Bethesda, MD, 20814, USA

Set-Aside

NONE

Documents

This scope was carved out of NOI-27-000004.

The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Piflufolastat F-18 injection drugs (Pylarify) from Lantheus (Notice of Intent to sole source)

AI Contract Breakdown

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Timeline

PostedSep 22

subcontract

Response DeadlineSep 29

Submission deadline

Response Deadline

09/29/2026, 02:00:00 PM UTCin 6 days

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health - Cc

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → National Institutes Of Health - Cc

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Office AddressN/A

ContactsNo contact information available

Full Description

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Supplies patient-ready unit doses of Piflufolastat F-18 injection (Pylarify™) for prime contractors on NIH clinical projects. Compounds radioactive drugs in clean rooms and hot cells per FDA and NRC regulations, ensuring correct activity levels and calibration. Performs wipe testing and radiation monitoring. Requires authorized commercial nuclear pharmacy licensing. Delivers patient-ready unit doses on demand.

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