Suppliers and packagers for FLUORODOPA F18

FLUORODOPA F18

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Feinstein	FLUORODOPA F18	fluorodopa f-18	SOLUTION;INTRAVENOUS	200655	NDA	THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH	13267-345-56	25 mL in 1 VIAL, GLASS (13267-345-56)	2019-10-10
Feinstein	FLUORODOPA F18	fluorodopa f-18	SOLUTION;INTRAVENOUS	200655	NDA	THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH	13267-346-57	30 mL in 1 VIAL, GLASS (13267-346-57)	2019-10-10

Suppliers for the Pharmaceutical Drug: Fluorodopa F18

Last updated: August 11, 2025

Overview of Fluorodopa F18

Fluorodopa F18, also known as 6-[18F]fluoro-L-DOPA, is a radiotracer predominantly used in positron emission tomography (PET) imaging, especially for diagnosing neurodegenerative disorders such as Parkinson’s disease. Its unique ability to cross the blood-brain barrier and mimic natural dopamine synthesis makes it invaluable for functional neuroimaging. Given its specialized application, sourcing high-quality Fluorodopa F18 involves navigating a niche market with rigorous manufacturing and regulatory standards.

Manufacturing and Supply Chain Dynamics

Fluorodopa F18 production hinges on the availability of cyclotrons capable of producing fluorine-18, a positron-emitting isotope with a short half-life (approximately 110 minutes). Because of its brief half-life, the radiotracer must be synthesized close to the imaging site or within a well-coordinated distribution network. This time-sensitive nature influences the geographical distribution, supplier choice, and logistical considerations.

Key players include radiopharmaceutical manufacturers operating dedicated cyclotron facilities and licensed suppliers authorized to produce and distribute fluorodopa F18. The supply chain's reliability is critical, given the tracer’s widespread clinical applications and the need for timely administration.

Leading Suppliers of Fluorodopa F18

1. Advanced Cyclotron Facilities and Radiopharmaceutical Producers

a. Novartis (Advanced Accelerator Applications)

Novartis, through its subsidiary Advanced Accelerator Applications (AAA), is a paramount supplier of radiopharmaceuticals, including Fluorodopa F18, primarily serving North America and Europe. AAA has invested heavily in cyclotron infrastructure and adheres to stringent regulatory standards (FDA, EMA), ensuring high-quality production.

b. GE Healthcare

GE Healthcare operates cyclotron facilities and offers radiopharmaceuticals, including Fluorodopa F18, integrated within broader imaging solutions. Its global footprint and extensive distribution network make it a reliable source, especially for large medical institutions.

c. IBA Molecular (Part of IBA Group)

IBA Molecular specializes in cyclotron services and radiotracer supply. Their integrated approach covers manufacturing, quality control, and distribution, catering primarily to North American and European markets.

2. Regional and Specialty Suppliers

a. Jubilant Radiopharma

Jubilant Radiopharma, based in India, has become a key regional supplier for Fluorodopa F18, serving Asia and parts of the Middle East. Their facilities operate under strict international standards, offering cost-effective and reliable supply options.

b. China Isotope and Radiopharmaceuticals

Several Chinese manufacturers have developed capacities for PET tracers, including Fluorodopa F18, aligning with the country's expanding healthcare infrastructure. These suppliers often operate under stringent domestic regulatory frameworks to ensure compliance with international standards.

c. Curium (Now Part of Iateros)

Curium, acquired by Iateros, offers a portfolio of PET radiopharmaceuticals, including Fluorodopa F18, primarily targeting European and North American markets. Their integrated supply chain helps maintain quality and availability.

3. Emerging and Academic Suppliers

Academic institutions and government-operated cyclotron facilities sometimes produce Fluorodopa F18 for research and limited clinical applications. Collaborations with pharmaceutical companies may lead to commercial-scale production, increasing overall supply options.

Factors Influencing Supplier Selection

• Regulatory Compliance: Suppliers must conform to Good Manufacturing Practices (GMP) and demonstrate regulatory approvals from respective agencies (FDA, EMA, etc.).
• Production Capacity & Turnaround: Given fluorodopa F18’s short half-life, suppliers with nearby cyclotron facilities or rapid distribution logistics are preferred.
• Quality & Purity Standards: Radiochemical purity, specific activity, and sterility are non-negotiable parameters influenced by supplier capabilities.
• Cost & Accessibility: Price competitiveness and geographical accessibility affect procurement decisions, particularly in emerging markets.
• Supply Continuity & Reliability: Consistent delivery schedules mitigate clinical disruptions, stressing the importance of established supplier relationships.

Supply Chain Challenges and Considerations

While the market for Fluorodopa F18 is specialized, it faces challenges such as:

• Limited Production Facilities: Few institutions worldwide possess cyclotron capabilities for fluorodopa F18 synthesis, constraining supply.
• Logistical Constraints: The isotope's short half-life demands complex logistics, especially for remote clinics.
• Regulatory Variability: International differences in radiopharmaceutical approvals can affect global supply chains.
• Cost Factors: High operational costs for cyclotron operation and regulation compliance influence pricing and accessibility.

Future Outlook

The demand for neuroimaging tracers like Fluorodopa F18 is expected to grow with advancing diagnostics for neurodegenerative diseases. This will likely incentivize investment in manufacturing infrastructure, expanding supplier networks, and developing regional distribution hubs. Partnerships among pharmaceutical companies, academic institutions, and government agencies could further stabilize and diversify the supply chain.

Key Takeaways

• Market leaders include Novartis (AAA), GE Healthcare, and IBA Molecular, with regional players like Jubilant Radiopharma expanding options.
• Supply chain reliability hinges on proximity to cyclotron facilities and swift distribution capabilities, given the isotope’s half-life.
• Regulatory compliance and quality standards are paramount, impacting supplier credibility and product availability.
• The limited number of production facilities constrains market capacity, highlighting growth opportunities driven by technological and infrastructural investments.
• International collaboration and regional manufacturing hubs could enhance supply stability and reduce costs.

Frequently Asked Questions (FAQs)

1. What are the main considerations when sourcing Fluorodopa F18?
Sourcing decisions should prioritize regulatory compliance, production capacity, radiochemical purity, logistical efficiency due to its short half-life, and cost.

2. Which companies dominate the global supply of Fluorodopa F18?
Leading suppliers include Novartis (AAA), GE Healthcare, and IBA Molecular, with regional players like Jubilant Radiopharma serving specific markets.

3. How does the short half-life of Fluorodopa F18 influence its supply chain?
Its approximately 110-minute half-life necessitates transportation within a tight window, favoring suppliers with nearby cyclotron facilities or rapid distribution networks.

4. Are there regional differences in Radiopharmaceutical supply standards?
Yes, regulatory standards vary by country, impacting approval processes and manufacturing quality, requiring suppliers to adhere to local and international regulations.

5. What future developments could impact the supply of Fluorodopa F18?
Advancements include increased cyclotron capacities, centralized regional production hubs, and partnerships to improve supply stability amid rising clinical demand.

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Sources:

[1] https://www.novartis.com/products/advanced-accelerator-applications
[2] https://www.gehealthcare.com/products/pet-ct-and-tracers
[3] https://www.iba-group.com/solutions/radiopharmaceuticals
[4] https://www.jubilantpharma.com/radiopharmaceuticals
[5] https://www.curiumpharma.com/products/