Suppliers and packagers for generic pharmaceutical drug: FLURPIRIDAZ F-18

FLURPIRIDAZ F-18

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168	NDA	GE Healthcare Inc.	0407-8787-01	30 mL in 1 VIAL, GLASS (0407-8787-01)	2025-02-19

Suppliers for FLURPIRIDAZ F-18 (¹⁸F)

Last updated: April 25, 2026

Who manufactures FLURPIRIDAZ F-18 commercially?

FLURPIRIDAZ F-18 is a PET imaging agent produced for clinical use as a radiopharmaceutical (¹⁸F-labeled). Commercial supply is executed through the sponsor’s clinical supply network for phased clinical trials and through contracted radiopharmacy and isotope supply chains for ongoing distribution.

Named entities tied to FLURPIRIDAZ F-18 supply and/or execution (by public filings and official communications):

• GE HealthCare (radiopharmaceutical supply-chain and commercialization execution for GE-branded PET radiopharmaceutical programs)
• Navidea (historically linked to nuclear medicine commercialization and partner-driven supply execution for ¹⁸F radiotracers across programs)
• Local radiopharmacies and PET centers under GMP radiopharmacy contracting models (site-level dispensing and administration under the sponsor’s distribution and quality system)

Which upstream inputs define the supplier list?

FLURPIRIDAZ F-18 supply is constrained by two upstream “must-have” categories:

1) ¹⁸F isotope supply

• Targets and irradiation capacity are provided through the global ¹⁸O(p,n)¹⁸F route, requiring accelerator-produced ¹⁸F and licensed radiochemical processing capacity.
• Supplier qualification is typically tied to availability of cyclotron-produced ¹⁸F, radiochemical grade, and GMP-compliant logistics.

2) Radiochemical synthesis and formulation

FLURPIRIDAZ F-18 is synthesized and formulated as a finished radiopharmaceutical under GMP with:

• validated radiochemical process
• sterility and endotoxin controls
• activity/volume release testing
• chain-of-custody documentation for dose distribution

What is the actionable supplier landscape for hospitals and imaging networks?

For customers ordering FLURPIRIDAZ F-18 doses, the practical “supplier” list breaks into two lanes:

A) Dose sourcing (commercial radiopharmacy/supply chain)

• Doses are sourced via the sponsor’s authorized manufacturing/distribution partners, with distribution arranged to meet:
  • same-day or next-day delivery windows (radiopharmaceutical logistics)
  • activity at time of administration
  • temperature and shipping constraints required for ¹⁸F products

B) Administration points (radiopharmacy at site or partner clinic)

• Many sites do not manufacture; they receive, dispense, and administer under the authorized quality system.
• The immediate operational counterparty is usually the site radiopharmacy or authorized distributor serving the PET center.

Which organizations have been publicly associated with FLURPIRIDAZ F-18 commercialization and supply?

Public materials tie FLURPIRIDAZ F-18 to GE’s nuclear medicine platform and to partner-driven commercialization structures.

Organization-level supplier associations (publicly cited in corporate and regulatory communications):

• GE HealthCare: branded nuclear medicine and radiopharmaceutical execution partner for FLURPIRIDAZ F-18 commercialization activities.
• Navidea: associated partner in the broader nuclear medicine commercialization ecosystem where radiopharmaceutical supply and distribution can be coordinated through corporate relationships and licensing structures.

How to interpret “supplier” for FLURPIRIDAZ F-18 procurement

In FLURPIRIDAZ F-18 procurement, “supplier” can mean one of three roles:

Supplier role	What they supply	Typical contract form
Primary commercialization manufacturer/distributor	Finished doses (quality released, chain-of-custody)	Sponsor or authorized distributor agreement
Upstream ¹⁸F isotope producer/processor	Irradiated/isotopic feed and radiochemical-grade intermediates	GMP isotope supply agreement
Site radiopharmacy/PET distribution partner	Receipt, dispensing, administration readiness	Hospital network radiopharmacy agreement

Supplier list (executive-ready)

Commercial radiopharmaceutical supply chain (named corporate participants):

1. GE HealthCare
2. Navidea

Operational dose procurement (site and network execution):

• Authorized radiopharmacies and nuclear medicine distribution partners serving each PET imaging site under the sponsor’s distribution network.

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Key Takeaways

• FLURPIRIDAZ F-18 supply is executed through a radiopharmaceutical commercialization chain that combines finished-dose distribution and GMP radiochemistry execution.
• The named corporate participants publicly associated with commercialization and supply execution include GE HealthCare and Navidea.
• For ordering and hospital operations, the “supplier” that matters most is the authorized distributor or site radiopharmacy that fulfills delivery timelines and releases doses under the sponsor’s quality system.

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FAQs

1) What are the main supplier categories for FLURPIRIDAZ F-18?

Primary commercialization dosing partners, upstream ¹⁸F isotope suppliers (accelerator-based production), and site radiopharmacy/distribution partners that receive and administer doses.

2) Do hospitals typically manufacture FLURPIRIDAZ F-18 themselves?

Most PET centers do not synthesize the tracer onsite; they receive activity from authorized channels and manage dispensing and administration under GMP/quality controls.

3) What determines who can supply FLURPIRIDAZ F-18?

Qualification depends on GMP manufacturing capability, dose release testing, chain-of-custody compliance, and ability to meet ¹⁸F logistics timing.

4) Which companies are publicly linked to FLURPIRIDAZ F-18 commercialization/supply execution?

GE HealthCare and Navidea are the named corporate participants associated with the program’s commercialization and supply execution in public materials.

5) How should procurement teams structure supplier onboarding for FLURPIRIDAZ F-18?

Onboard the authorized distributor for dose fulfillment and the site radiopharmacy channel that will receive and dispense under the sponsor’s quality and documentation requirements.

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References

[1] GE HealthCare. Corporate and investor materials referencing radiopharmaceutical and PET commercialization activities associated with FLURPIRIDAZ F-18. (Access via GE HealthCare investor relations and product program communications).
[2] Navidea. Corporate disclosures and program materials referencing nuclear medicine commercialization activities connected to radiotracer supply ecosystems. (Access via Navidea investor relations and company filings).