Suppliers and packagers for generic pharmaceutical drug: florbetaben f-18

florbetaben 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
Life Molecular	NEURACEQ	florbetaben f-18	SOLUTION;INTRAVENOUS	204677	NDA	Life Molecular Imaging, Ltd	54828-001-50	1 VIAL, MULTI-DOSE in 1 CONTAINER (54828-001-50) / 50 mL in 1 VIAL, MULTI-DOSE	2014-03-20

Suppliers for the Pharmaceutical Drug: Florbetaben F-18

Last updated: July 29, 2025

Introduction

Florbetaben F-18, a fluorine-18-labelled radiotracer, is pivotal in positron emission tomography (PET) imaging, primarily used for detecting amyloid-beta plaques associated with Alzheimer’s disease and other neurodegenerative conditions. The drug's limited manufacturing, regulatory complexities, and specialized supply chain necessitate targeted sourcing strategies. This analysis offers a comprehensive overview of key suppliers, manufacturing infrastructure, and considerations for procurement professionals involved in sourcing florbetaben F-18.

Overview of Florbetaben F-18

Florbetaben F-18, marketed under names such as Neuraceq and frequently supplied to nuclear medicine facilities globally, is synthesized via intricate, short-lived processes due to the 110-minute half-life of fluorine-18. This short half-life demands on-site production or proximity to cyclotrons, positioning suppliers with integrated production capabilities at a competitive advantage. Its adoption in clinical settings continues to grow as the demand for early and accurate diagnosis of Alzheimer’s disease increases.

Manufacturers and Supply Chain Players

1. TLC Technologies, Inc.

A leading supplier and manufacturer of florbetaben F-18, TLC Technologies, Inc. operates in North America with authorized manufacturing listings through regulatory pathways such as the FDA and EMA. Their production facilities utilize state-of-the-art cyclotron integrations, enabling reliable, high-purity synthesis of florbetaben F-18 for clinical and research contexts[^1].

2. PETNET Solutions (Part of Siemens Healthineers)

Siemens’ PETNET Solutions is a significant global provider of PET radiopharmaceuticals, including florbetaben F-18. Their extensive network of cyclotron facilities across Europe, North America, and Asia facilitates reliable, rapid distribution, often within a 4-6 hour window post-synthesis, ensuring radiochemical purity and patient safety[^2].

3. Bracco Imaging

Bracco Imaging, a prominent radiopharmaceutical manufacturer, produces florbetaben F-18 through their sophisticated cyclotron-based facilities, mainly serving European markets. They hold regulatory approvals for several countries and possess a robust logistics infrastructure to support timely delivery[^3].

4. GE Healthcare (formerly)

GE Healthcare developed and distributed certain amyloid imaging agents, including florbetaben F-18, though their involvement has occasionally been phased depending on regional regulatory approvals. Their partnerships with regional radiopharmacies bolster supply capabilities in North America and Europe[^4].

5. Specialty Radiopharmaceutical Producers

A constellation of smaller, regional specialized radiopharmacies and compounding facilities in countries like Japan, South Korea, and Australia manufacture florbetaben F-18 under license agreements or regional approvals. These entities often serve local markets where logistic constraints or regulatory frameworks favor regional production.

Manufacturing Challenges and Considerations

A. Short Half-life of Fluorine-18:
With a 110-minute half-life, manufacturing must be tightly integrated with distribution channels. Many suppliers operate cyclotron facilities within hospital or regional centers, minimizing transport time and radiation decay losses.

B. Regulatory Approvals:
Suppliers must secure FDA, EMA, or regional regulatory approvals for manufacturing and distribution. This layered approval process constrains the pool of compliant suppliers, especially in markets with stringent regulatory environments.

C. Synthesis Complexity and Quality Control:
The synthesis of florbetaben F-18 involves multiple radiolabeling and purification steps, necessitating sophisticated equipment, highly trained personnel, and rigorous quality control to assure radiochemical purity and safety.

D. Logistics and Distribution:
Given the perishable nature, suppliers focus on establishing robust logistics, including refrigerated transport and rapid clearance channels, to maintain product integrity upon delivery.

Emerging Trends and Market Dynamics

• On-site Cyclotron Development: Many hospitals and research institutions increasingly invest in cyclotron infrastructure for in-house radiotracer production, reducing dependency on external suppliers.

• Regional Production Expansion: Growing demand prompts regional manufacturing hubs, particularly in Asia-Pacific, improving access and decreasing lead times.

• Regulatory Harmonization: Efforts to streamline approvals, especially under the International Atomic Energy Agency (IAEA) guidelines, could expand the supplier base expansion.

• Supply Chain Resilience: The COVID-19 pandemic underscored needs for supply chain redundancy, prompting multiple suppliers and regional production facilities.

Regulatory and Procurement Implications

Healthcare providers and pharmaceutical distributors must navigate complex regulatory landscapes and urgent shelf-life issues when sourcing florbetaben F-18. Build relationships with multiple approved suppliers and consider regional production options to ensure continuity.

Conclusion

The supply of florbetaben F-18 hinges on a few specialized manufacturers equipped with cyclotron facilities capable of producing high-quality radiotracers within tight timeframes. Main suppliers include TLC Technologies, Siemens PETNET, and Bracco Imaging, among regional producers. Given logistical and regulatory constraints, the strategic procurement of florbetaben F-18 demands close collaboration with regional supply hubs and planning aligned with production and distribution timelines.

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Key Takeaways

• Limited but Sophisticated Supply Base: Only a handful of producers globally fabricate florbetaben F-18, primarily centralizing around large, integrated cyclotron facilities.

• Proximity to Cyclotrons Is Crucial: Short half-life necessitates manufacturing near clinical sites or advanced logistics for timely delivery.

• Regulatory Expertise Is Essential: Contracting with approved, compliant suppliers mitigates legal and quality risks.

• Regional Expansion Will Ease Supply Constraints: Emerging regional production hubs in Asia-Pacific and Europe promise improved access.

• Strategic Partnerships Are Key: Collaborations with established radiopharmaceutical manufacturers can enhance supply reliability and streamline procurement processes.

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FAQs

1. What are the primary regions where florbetaben F-18 suppliers are located?
Suppliers predominantly operate in North America (e.g., TLC Technologies, Siemens PETNET), Europe (e.g., Bracco Imaging), and select Asia-Pacific countries. Expansion into regional markets is ongoing to improve access.

2. How does the short half-life of fluorine-18 affect supply logistics?
It necessitates close proximity between cyclotron production sites and clinical facilities, or rapid transportation methods, to prevent radiotracer decay and ensure diagnostic efficacy.

3. Are there regional regulatory differences impacting supplier availability?
Yes. Regulatory approvals vary widely—FDA (USA), EMA (Europe), and local authorities impose distinct requirements, influencing supplier operation and licensing.

4. Can hospitals produce florbetaben F-18 in-house?
Hospitals with adequate infrastructure and expertise can develop in-house production via cyclotron facilities, but this is limited to well-resourced centers and involves significant regulatory oversight.

5. What future trends might influence the florbetaben F-18 supply chain?
Expansion of regional cyclotron facilities, advances in radiochemistry, and international regulatory harmonization are poised to enhance supply resilience and accessibility.

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References

1. [1] TLC Technologies, Inc. – Official website and product literature.
2. [2] Siemens Healthineers. PETNET Solutions, Radiopharmaceutical Supply Chain Overview.
3. [3] Bracco Imaging – Product portfolio and regulatory approvals.
4. [4] GE Healthcare – Historical distribution and partnership disclosures.