FLURPIRIDAZ F-18: Pharmaceutical manufacturers, suppliers, and distributors

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: October 9, 2025

Introduction

Flurpiridaz F-18, a radiopharmaceutical extensively investigated for myocardial perfusion imaging, remains at the forefront of nuclear cardiology research. Its unique mechanism—targeting mitochondrial complex I—renders it a promising diagnostic agent with potential advantages over existing tracers like Technetium-99m-based compounds. Although not yet commercially widespread, several companies and research institutions supply or participate in the development of Flurpiridaz F-18, primarily in clinical trial or investigational contexts. This overview delineates current suppliers, manufacturing collaborations, and market players integral to this promising radiopharmaceutical.

Manufacturers and Supply Chains of Flurpiridaz F-18

1. Radiopharmaceutical Manufacturers and Development Companies

a) Avid Radiopharmaceuticals

Background: Avid Radiopharmaceuticals, a subsidiary of Eli Lilly and Company, historically played a pioneering role in developing Flurpiridaz F-18. The company advanced the compound through preclinical and clinical phases, leveraging its expertise in radiopharmaceuticals.
Current Status: As of recent updates, Avid's development efforts for Flurpiridaz F-18 have slowed, with the company shifting focus towards other radiotracers. Nonetheless, their foundational research and early supply agreements laid an essential groundwork for other entities.

b) Lantheus Holdings, Inc.

Relevance: Lantheus, a prominent manufacturer of nuclear imaging agents, has explored the development and commercialization of new myocardial perfusion tracers. While they have been involved in the broader space of PET tracers, specific public disclosures about Flurpiridaz F-18 supply agreements remain limited.
Supply Chain: They possess manufacturing capabilities for F-18 radiotracers and participate in research collaborations, possibly serving as a supplier or partner if development progresses.

c) Jubilant DraxImage (Jubilant Pharmova Limited)

Role: Jubilant DraxImage manufactures a variety of PET tracers and has the infrastructure conducive to scaling up radiopharmaceutical production.
Potential Involvement: While not officially announced as a supplier for Flurpiridaz F-18, their existing manufacturing facilities could facilitate future supply should clinical trials or commercialization proceed.

d) Rad4Med

Focus: A specialized radiopharmaceutical company investing in PET tracers for myocardial perfusion.
Relevance: Rad4Med has announced interests in developing and supplying Flurpiridaz F-18, especially as clinical trial data support its efficacy.

2. Contract Manufacturing Organizations (CMOs)

a) PETNET Solutions (a Siemens Healthineers company)

Purpose: PETNET specializes in the production of PET radiopharmaceuticals, including F-18 compounds.
Capabilities: With sophisticated cyclotron and radiochemistry facilities, PETNET can produce a range of F-18 labeled tracers on demand, potentially including Flurpiridaz F-18 under collaborative arrangements or licensing agreements.

b) Cardinal Health / General Electric Healthcare

Involvement: These giants operate radiopharmaceutical manufacturing services, leveraging extensive cyclotron networks.
Potential Role: They could produce Flurpiridaz F-18 if scaled for commercial distribution, contingent on regulatory approval and licensing.

c) Local and Regional Cyclotron Facilities

Context: Many hospitals and research centers operate cyclotrons capable of synthesizing F-18 radiotracers.
Examples: Cleveland Clinic, Johns Hopkins University, and other research hospitals possess the infrastructure to produce investigational radiotracers, potentially including Flurpiridaz F-18 under clinical trial scenarios.

3. Supply Through Licensing and Collaborations

Many pharmaceutical companies and research institutions rely on licensing agreements to manufacture and supply Flurpiridaz F-18. The complex synthesis process, requiring high-precision radiochemistry and prompt delivery due to the isotope’s short half-life (approximately 110 minutes), limits proliferation to specialized facilities.

Key Licensing Partners:

Eli Lilly – Historically involved in licensing the compound, although current active commercialization efforts are limited.
Research Collaborators – Several academic labs and clinical centers partner with manufacturing entities to access Flurpiridaz F-18 for clinical evaluation.

4. Geographic Considerations in Supply

North America

The U.S. possesses multiple cyclotron facilities capable of producing F-18 tracers, but widespread commercial supply of Flurpiridaz F-18 remains limited due to the still-in-progress regulatory approvals.
Companies like PETNET and local research centers serve as primary sources for investigational use.

Europe

European manufacturers, such as Nordion (now part of Sterigenics), have historically supplied F-18 tracers, but specific suppliers for Flurpiridaz F-18 are sparse.
Regulatory hurdles pose additional barriers to widespread commercialization.

Asia-Pacific

Regional radiopharmacies and university hospitals with cyclotron infrastructure are potential suppliers. However, no major commercial distributor is currently recognized for Flurpiridaz F-18.

Regulatory and Market Development Status

The development and supply of Flurpiridaz F-18 are highly contingent upon regulatory approvals. The compound has undergone multiple clinical trials, notably Phase III, but has yet to secure FDA approval for routine clinical use. Consequently, most supply is limited to investigational and research applications, typically facilitated via collaboration agreements with research institutions and specialized CMO facilities.

Future Outlook and Supply Opportunities

Pending successful regulatory approval, substantial scaling of manufacturing will be necessary. Licensing agreements with CMOs and partnerships with established radiopharmaceutical manufacturers will be pivotal. Investment in regional cyclotron networks and dedicated radiochemistry facilities will also be essential to meet future demand.

Key Takeaways

Limited Commercial Suppliers: Currently, Flurpiridaz F-18 remains predominantly in the investigational phase, with no widespread commercial supplier. Existing supply is primarily through research collaborations and specialized CMOs.
Manufacturing Infrastructure: The short half-life of F-18 necessitates proximity to cyclotron facilities or on-site production, limiting distribution opportunities but enabling localized supply.
Collaborative Development: Companies like Jubilant DraxImage and Rad4Med are likely to become key suppliers if regulatory approval transitions toward commercialization.
Regional Variability: North America has the most developed infrastructure for F-18 tracers, but access is limited to clinical trial settings.
Regulatory Impact: FDA approval remains a critical milestone that will unlock broader supplier networks and commercial availability.

FAQs

Is Flurpiridaz F-18 commercially available?
Currently, no. Flurpiridaz F-18 has completed clinical trials but has not yet received FDA approval for routine clinical use, limiting commercial availability.
Who are the main suppliers of Flurpiridaz F-18 today?
Most suppliers are research institutions, specialized CMOs, or companies engaged in clinical trials. Major commercial suppliers are yet to emerge post-approval.
Can hospitals produce Flurpiridaz F-18 locally?
Only facilities equipped with advanced cyclotron and radiochemistry infrastructure can produce F-18 tracers. Most hospitals rent or purchase from commercial suppliers for investigational purposes.
What is the role of CMOs in Flurpiridaz F-18 supply?
CMOs such as PETNET could manufacture Flurpiridaz F-18 upon licensing, especially if clinical and regulatory milestones are achieved, bridging the gap between research and commercial supply.
What factors influence the future supply of Flurpiridaz F-18?
Regulatory approval, manufacturing scalability, licensing agreements, and regional infrastructure development are critical determinants. Increased demand post-approval will stimulate supply chain expansion.

References

ClinicalTrials.gov. (2022). "Flurpiridaz F-18 trials."
Eli Lilly & Co. (2018). "Development pipeline of PET tracers."
Jubilant DraxImage. (2022). "Radiopharmaceutical production capabilities."
PETNET Solutions. (2021). "Manufacturing services for PET radiopharmaceuticals."
European Society of Nuclear Medicine. (2020). "Status of myocardial perfusion PET tracers."

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