Bulk Pharmaceutical API Sources for SODIUM FLUORIDE F 18

Bulk Pharmaceutical API Sources for SODIUM FLUORIDE F 18

Vendor	Vendor Homepage	Vendor Sku	API Url
Smolecule		S655762
THE BioTek		bt-457421
BenchChem		B1260693
J&H Chemical Co.,ltd		JH215115
RR Scientific		R152584

Bulk Active Pharmaceutical Ingredient (API) Sources for: SODIUM FLUORIDE F 18

Last updated: August 2, 2025

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Introduction

Sodium Fluoride F-18 is a vital radiopharmaceutical used predominantly in Positron Emission Tomography (PET) imaging to evaluate bone metastasis and other skeletal disorders. As a radioactive isotope with a half-life of approximately 110 minutes, the F-18 isotope’s transient nature necessitates the rapid, reliable sourcing of its precursor, Sodium Fluoride (NaF), in bulk quantities for pharmaceutical production. Its supply chain comprises specialized vendors capable of delivering high-purity APIs compliant with stringent regulatory standards.

This article delineates the key sources of bulk Sodium Fluoride F-18, emphasizing the principles of production, regulatory compliance, and strategic procurement insights essential for stakeholders in nuclear medicine, radiopharmacy, and pharmaceutical manufacturing sectors.

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Understanding Sodium Fluoride F-18 Production

Production Methodology:
Sodium Fluoride F-18 is produced via cyclotrons, which accelerate protons to bombard enriched Oxygen-18 (^18O) water, resulting in the [^{18}O(p,n)^{18}F] nuclear reaction. Post-irradiation, the radioactive fluoride ions are separated and formulated into Sodium Fluoride, suitable for clinical application ([1]).

Key Production Parameters:

• Enriched ^18O Water Availability: The core raw material.
• Cyclotron Technology: Capable of producing F-18 at sufficient scale.
• Radiochemical Processing: Ensures high radiochemical purity (>95%), pyrogen-free, and suitable for human injection.
• Regulatory Compliance: Good Manufacturing Practice (GMP)-certified facilities are mandatory.

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Global Sources of Bulk Sodium Fluoride F-18

1. Established Radiopharmaceutical Suppliers

a. Cardinal Health (formerly Bracco Diagnostics)
Cardinal Health is a major provider of radiopharmaceuticals, including F-18 Fluoride. The company operates integrated cyclotron and radiopharmacy facilities globally, primarily in North America and Europe ([2]). They supply bulk F-18 formulations meeting pharmacopeial standards, emphasizing consistent quality and regulatory adherence.

b. Nordion (Canada) / Nordion (part of Sterigenics)
Nordion has historically supplied medical isotopes, including F-18, primarily through partnerships with cyclotron facilities in North America. Their focus supports centralized production, driven by GMP compliance.

c. Advanced Accelerator Applications (AAA), a Novartis company
AAA specializes in radiopharmaceutical manufacturing, including F-18 fluoride solutions produced via proprietary cyclotron systems, with a strict compliance framework. They serve major markets with high-volume production capacity ([3]).

d. Jubilant Radiopharma
A significant player in India and the Middle East, Jubilant offers bulk quantities of F-18, focusing on regional supply chain security ([4]).

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2. Regional Cyclotron Facilities and Contract Manufacturers

a. PETNET Solutions
As a subsidiary of Siemens, PETNET operates multiple cyclotrons globally, with capacity for custom production and bulk supply of F-18 fluoride solutions ([5]).

b. Cyclotron and Radiopharmaceutical Centers
Several regional facilities, such as in Europe (e.g., IBA Particle Therapy, GE Healthcare), produce bulk quantities of F-18 for local distribution. While many operate under tight regulation, some serve as original API sources for centralized radiopharmacies or distributors.

c. Contract Manufacturing Organizations (CMOs)
Specialized CMOs like Jubilant Radiopharma and Triad Isotopes contract with hospitals and governments to produce and supply F-18 bulk APIs in regions where direct manufacturing is less feasible ([6]).

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Sources of Raw Materials and Local Production

• Enriched Oxygen-18 Water Suppliers: Suppliers like Isotope Technologies Dresden (ITD) and Rotem Industries supply high-purity ^18O-enriched water critical for isotope production.
• Cyclotron Equipment Providers: Companies such as IBA, GE Healthcare, and ion beam systems manufacturers are integral to generating F-18, thus directly affecting API availability.

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Regulatory and Quality Considerations

cGMP Compliance:
Suppliers must meet rigorous standards set by regulatory agencies such as the U.S. FDA, EMA, and PMDA. Quality assurance programs include sterility, pyrogen testing, radionuclidic purity, and compliance with pharmacopeial monographs (USP, EP).

Licensing and Export Controls:
F-18’s radioactive nature subjects it to strict export/import regulations, requiring licenses, transportation protocols, and handling provisions conforming to IAEA and national regulatory bodies.

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Emerging Sources and Future Outlook

Innovative Production Techniques:
Research into alternative production methods, including solid target irradiation and automation, aims to improve yield and reduce production times, thereby expanding API sources.

Regional Expansion:
Growing investment in cyclotron infrastructure in Asia-Pacific, the Middle East, and Eastern Europe promises more localized, reliable bulk API sources, diminishing dependency on Western suppliers and reducing logistical bottlenecks.

Supply Chain Resilience:
Post-pandemic insights underscore the necessity for diversified sourcing strategies, including multiple suppliers and regional manufacturing hubs to mitigate supply interruptions.

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Conclusion

The procurement of bulk Sodium Fluoride F-18 API relies on a global network comprising dedicated cyclotron facilities, specialized radiopharmaceutical manufacturers, and raw material suppliers committed to quality and compliance. Leading organizations such as Cardinal Health, AAA, PETNET, and Jubilant Radiopharma serve as primary sources, leveraging advanced cyclotron technology and stringent regulatory adherence to deliver consistency, safety, and efficacy in SODIUM FLUORIDE F-18 production.

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Key Takeaways

• Diversify your supply chain by engaging with both established global suppliers and regional cyclotron facilities to ensure steady API availability.
• Prioritize regulatory compliance by sourcing from vendors certified under GMP standards, minimizing risks of batch rejection or regulatory issues.
• Monitor technological advancements in cyclotron and radiochemistry processes to access higher yields and improved purity.
• Develop strategic inventory management considering F-18’s short half-life to synchronize production schedules with clinical demands.
• Invest in regional infrastructure to reduce dependence on distant suppliers, thereby enhancing supply chain resilience.

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Frequently Asked Questions (FAQs)

1. What are the key characteristics to look for in a supplier of Sodium Fluoride F-18?
   Suppliers should demonstrate GMP compliance, high radiochemical purity (>95%), certified sterility, reliable production capacity, and a track record of regulatory adherence.

2. How does regional regulation affect the sourcing of F-18 APIs?
   Regional regulations influence licensing, export/import controls, and quality standards. Knowledge of local regulatory bodies, like the FDA in the US or EMA in Europe, is essential for compliant sourcing.

3. Can synthetic routes replace cyclotron-based production for F-18?
   Currently, cyclotron-based methods remain the standard for F-18 production due to the isotope’s origin via nuclear reactions. Alternative methods are under research but not yet commercially viable.

4. What logistical challenges are associated with bulk F-18 API sourcing?
   The short half-life mandates rapid delivery, specialized transportation, and close integration between production sites and clinical facilities to prevent decay-related losses.

5. Are there emerging suppliers capable of bulk F-18 API production?
   Yes, regional investments in cyclotron infrastructure and technological innovations are expanding the pool of suppliers, especially in Asia and the Middle East.

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References

[1] International Atomic Energy Agency, "Production of F-18 for PET," IAEA Report, 2019.
[2] Cardinal Health, "Radiopharmaceuticals Portfolio," Official Website, 2023.
[3] Advanced Accelerator Applications, "F-18 Production Capabilities," Novartis Announcements, 2022.
[4] Jubilant Radiopharma, "Regional API Supply," Company Reports, 2023.
[5] PETNET Solutions, "Global PET Radiopharmaceutical Supply Network," 2023.
[6] Triad Isotopes, "Radiopharmaceutical Manufacturing," Industry Overview, 2022.