FLUCICLOVINE F-18: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054	NDA	Blue Earth Diagnostics	69932-001-30	30 mL in 1 VIAL, MULTI-DOSE (69932-001-30)	2016-05-27
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054	NDA	Blue Earth Diagnostics	69932-001-50	50 mL in 1 VIAL, MULTI-DOSE (69932-001-50)	2016-05-27
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Fluciclovine F-18, commercially known as Axumin, is a radiopharmaceutical agent used primarily in PET imaging for recurrent prostate cancer detection. It is a synthetic amino acid analog labeled with the radioactive isotope Fluorine-18. Due to its specialized nature, the supply chain for Fluciclovine F-18 is tightly controlled, involving multiple stages from raw material sourcing to manufacturing and distribution. This article provides a comprehensive overview of current suppliers and key players involved in the production and distribution of Fluciclovine F-18, critical for stakeholders in healthcare, logistics, and pharmaceutical industries.

Manufacturers of Fluciclovine F-18

1. Blue Earth Diagnostics (Now part of GE Healthcare)

Blue Earth Diagnostics pioneered the commercial development of Fluciclovine F-18. Their flagship product, Axumin, received approval from the U.S. Food and Drug Administration (FDA) in 2016 and subsequently gained approvals in various international markets. As the leading commercial supplier, Blue Earth Diagnostics (acquired by GE Healthcare in 2019) is known for its integrated supply chain, encompassing radiopharmaceutical manufacturing, distribution, and technical support.

Manufacturing and Distribution:
Blue Earth Diagnostics operates state-of-the-art cyclotron facilities for F-18 production, coupled with distribution centers strategically located across major regions, including the United States and Europe. They ensure timely distribution to hospitals and imaging centers, maintaining the isotope's short half-life of approximately 110 minutes, critical for clinical efficacy.

2. IBA Molecular (Part of IBA Group)

IBA Molecular specializes in the production of radioisotopes and radiopharmaceuticals and offers customized solutions for nuclear medicine providers. Although primarily focused on other radiotracers such as FDG (Fluorodeoxyglucose), IBA also produces F-18 isotopes, potentially serving as a secondary or regional supplier for Fluciclovine F-18, particularly in Europe.

Supply Chain:
Their facilities incorporate advanced cyclotron technology that enables high-yield F-18 isotope production. They serve hospitals, diagnostic labs, and research institutions, securing a vital role in the European supply landscape.

3. Nordion (Part of Nordion/Best Theratronics)

Nordion specializes in medical isotopes, including F-18, primarily for research and small-scale clinical applications. Their isotope production is centered in Canada, employing cycloton upgrades for extensive F-18 generation. While not a commercial supplier of Axumin directly, Nordion’s isotopes are critical for regional manufacturing and compound synthesis.

Raw Material and Isotope Suppliers

4. Cyclotron Facilities

Since F-18 is produced via cyclotrons by irradiating enriched oxygen-18 water (H2^18O), the primary suppliers of high-purity H2^18O are crucial to the supply chain:

Siemens Healthcare
Siemens offers cyclotron solutions that produce F-18, as well as the necessary enriched oxygen-18 water, which is supplied to radiopharmacies worldwide.
GE Healthcare
Besides manufacturing cyclotrons, GE supplies H2^18O and cyclotron maintenance to ensure clean, efficient isotope production.
National and Regional Cyclotron Facilities
Several regional centers in the US, Europe, and Japan operate dedicated cyclotrons for isotope production, often collaborating with pharmaceutical companies or government agencies to ensure supply stability.

Distribution Channels

The short half-life of Fluorine-18 imposes rigorous timing constraints on distribution:

Logistics Providers:
Companies such as Curium, Cardinal Health, and Jubilant Radiopharma provide specialized logistics services tailored to radiopharmaceuticals, including temperature-controlled transportation and rapid delivery networks.
Hospital and Imaging Center Suppliers:
Many hospital-based radiopharmacies procure F-18 from regional suppliers, often relying on licensed distributors to maintain regulatory compliance and logistical efficiency.

Regulatory Considerations and Market Dynamics

Due to the radioactive nature and strict regulatory oversight (by the FDA, EMA, and other authorities), only a limited number of manufacturers and licensed distributors operate in the Fluciclovine F-18 supply chain. Patent protections, manufacturing capacity, and regional approvals influence supplier diversity and market competition.

Recent trends suggest increased investments in cyclotron infrastructure and alternative manufacturing platforms to bolster supply, especially given the rising demand for prostate cancer imaging.

Emerging and Potential Suppliers

Academic and Public-Private Partnerships:
Several research institutions are developing in-house cyclotron capabilities to produce F-18 compounds, potentially becoming future suppliers.
New Entrants and Licensing Agreements:
As the global demand for advanced PET tracers grows, pharmaceutical companies may enter licensing agreements with existing cyclotron facilities or develop new manufacturing sites.

Key Challenges in Supply Chain

Short Half-life of F-18:
The 110-minute half-life necessitates proximity between production sites and clinical sites, limiting geographical flexibility.
Regulatory Compliance:
Strict manufacturing and transportation regulations demand significant investment and operational oversight.
Supply Volatility:
Fluctuations in demand, combined with production delays, can impact availability, emphasizing the need for diversified supply sources.

Conclusion

The supply of Fluciclovine F-18 hinges primarily on Blue Earth Diagnostics (now part of GE Healthcare) with secondary contributions from regional suppliers such as IBA Molecular and Nordion. The isotope’s production depends on high-precision cyclotron facilities worldwide, with specialized logistics providers ensuring timely delivery to clinical sites. As demand increases, particularly with expanding prostate cancer imaging, supply chain robustness will become increasingly critical.

Key Takeaways

Primary Supplier:
Blue Earth Diagnostics (GE Healthcare) dominates the commercial supply of Axumin, with established manufacturing and distribution channels.
Secondary and Regional Suppliers:
IBA Molecular and Nordion contribute to regional isotope supply, especially in Europe and Canada.
Isotope and Raw Material Providers:
Cyclotron manufacturers like Siemens and GE Healthcare provide critical infrastructure for F-18 production, sourcing highly purified H-18O water.
Logistics and Distribution:
Specialized logistics firms are integral to maintaining supply due to F-18’s short half-life and compliance requirements.
Market Outlook:
Increased investments in cyclotron infrastructure and research collaborations are poised to diversify and stabilize the supply chain.

FAQs

1. Who are the main commercial suppliers of Fluciclovine F-18?
Blue Earth Diagnostics, now part of GE Healthcare, is the primary commercial supplier globally, with additional regional providers like IBA Molecular supporting specific markets.

2. What is the typical production process for Fluciclovine F-18?
It involves cyclotron irradiation of enriched oxygen-18 water to produce F-18 isotopes, which are then incorporated into the Fluciclovine compound under sterile, regulated conditions.

3. How does the short half-life of F-18 impact its supply chain?
With a half-life of approximately 110 minutes, production and distribution must be tightly coordinated, often within a few hours, necessitating proximity of cyclotron facilities to clinical centers.

4. Are there plans to expand the supply chain for Fluciclovine F-18?
Yes, ongoing investments in regional cyclotron facilities and emerging research into alternative production methods aim to enhance supply robustness.

5. What regulatory hurdles influence the supplier landscape?
Strict GMP compliance, licensing, and transportation regulations limit the number of qualified suppliers and necessitate rigorous quality control and logistical protocols.

Sources:
[1] FDA approval documentation for Axumin (2016)
[2] GE Healthcare press releases on Blue Earth Diagnostics acquisition
[3] European Medicines Agency (EMA) approval details
[4] Industry reports on radiopharmaceutical supply chains and cyclotron infrastructure

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