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

FLUORODOPA 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
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 F-18

Last updated: August 7, 2025

Introduction

Fluorodopa F-18 (also known as 6-fluoro-L-DOPA or FDOPA) is a radioactive isotope-labeled radiotracer widely used in positron emission tomography (PET) imaging. Primarily applied in neurology for diagnosing Parkinson’s disease, neuroendocrine tumors, and other neurodegenerative conditions, FDOPA’s growing clinical utility demands reliable sourcing of high-purity, compliance-certified radiotracers. This article assesses leading suppliers of Fluorodopa F-18, considering manufacturing capabilities, regulatory adherence, market presence, and strategic partnerships.

Global Market Landscape

FDOPA production operates within a niche segment of radiopharmaceutical manufacturing, combining advanced nuclear chemistry with strict regulatory oversight. Suppliers must meet rigorous standards such as Good Manufacturing Practice (GMP) and possess certification from authorities like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and equivalents worldwide. The global supply chain for FDOPA is characterized by specialized production centers often located in regions with established nuclear medicine infrastructure, notably North America and parts of Europe and Asia.

Major Suppliers of Fluorodopa F-18

1. IBA Molecular (Part of IBA Group)

Overview:
IBA Molecular, a subsidiary of the IBA Group, is among the prominent providers of radiopharmaceuticals globally. The company offers FDOPA among its portfolio of PET tracers, with manufacturing facilities capable of producing high specific activity, pharmaceutical-grade radiotracers.

Capabilities & Offerings:

• Production of FDOPA at state-of-the-art cyclotrons with GMP compliance.
• Distribution networks across North America, Europe, and Asia.
• Custom synthesis services supporting clinical research and commercial applications.

Regulatory Status:
Considered compliant with international standards including FDA and EMA approvals, with comprehensive documentation facilitating their distribution in multiple jurisdictions.

Strategic Strengths:

• Integrated manufacturing and distribution channels enable fast delivery.
• Strong focus on quality assurance and regulatory compliance.

2. GE Healthcare (formerly PETtrace)

Overview:
GE Healthcare’s PETtrace line provides cyclotrons and radiotracer production systems. While primarily a device manufacturer, GE partners with radiotracer producers, including FDOPA suppliers, by offering integrated production solutions.

Capabilities & Offerings:

• Cyclotrons facilitating on-site synthesis.
• Customized radiopharmaceutical production processes aligned with regulatory standards.

Supply Chain Role:
GE’s role is often in enabling hospitals and imaging centers to produce FDOPA locally, complementing third-party vendors.

3. Siemens Healthcare (now part of Siemens Healthineers)

Overview:
Siemens Healthineers supplies medical imaging and cyclotron systems that can support FDOPA production. The company indirectly influences the supply chain by enabling in-house radiotracer synthesis capability.

Key Focus:

• Facilitating dose preparation and distribution for PET imaging.
• Supporting regulatory-compliant production environments for radiopharmaceuticals.

4. Jubilant Radiopharma

Overview:
Jubilant Radiopharma is a leading radiopharmaceutical solutions provider serving the North American market, with a focus on both diagnostic and therapeutic radiotracers.

FDOPA Supply:

• Produces and distributes FDOPA following strict GMP protocols.
• Offers comprehensive support for hospital-based PET imaging centers, including cadences for radiotracer supply and regulatory documentation.

Market Presence & Certifications:

• Approved by FDA for certain uses.
• Robust distribution infrastructure supporting timely delivery across the U.S.

5. Cyclomedica (Australia)

Overview:
Cyclomedica specializes in the production of radiotracers for medical imaging, with an emphasis on PET imaging agents including FDOPA. Their facilities are compliant with international GMP standards.

Strengths:

• Regional coverage in Asia-Pacific, leveraging local nuclear medicine infrastructure.
• Strategic partnerships with healthcare providers for timely supply.

6. Advanced Accelerator Applications (a Novartis Company)

Overview:
Focused on innovative radiopharmaceuticals, Advanced Accelerator Applications (AAA) produces a variety of tracers, including FDOPA, with high standards of quality and compliance.

Capabilities & Market Reach:

• State-of-the-art manufacturing units in Europe and the U.S.
• Global distribution channels ensuring supply to key markets.

Regulatory & Quality:

• Meets stringent GMP and regulatory requirements, facilitating cross-border distribution.

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Key Factors Influencing Supplier Selection

• Regulatory Compliance: Suppliers must hold requisite approvals (FDA, EMA) to ensure legal distribution and use.
• Production Capacity: Adequate GMP-certified facilities and scalable production capabilities are vital to meet demand fluctuations.
• Delivery & Logistics: Rapid, reliable distribution channels reduce decay-related losses, a critical aspect given FDOPA’s short half-life (~110 minutes).
• Quality & Purity: High specific activity and radionuclidic purity are non-negotiable for clinical use.
• Cost & Accessibility: Competitive pricing and regional availability influence procurement decisions at institutional levels.

Emerging Trends and Opportunities

The growing adoption of PET imaging in neurology signifies expanding demand for FDOPA, encouraging investment in local cyclotron infrastructure to enable on-site production. Companies like GE and Siemens are fostering this trend, but third-party radiopharmaceutical suppliers remain crucial for immediate, scalable supply.

Concurrently, innovations in cyclotron technology and improved radiotracer synthesis methods are expected to enhance yield, purity, and cost-effectiveness. Partnerships between radiopharmaceutical firms and medical centers increase supply resilience and customization for clinical needs.

Regulatory and Market Challenges

The scarcity of high-specification production facilities, regulatory hurdles across jurisdictions, and the brief half-life of FDOPA cast complexities on the supply chain. Suppliers navigating these challenges prioritize quality management, standardized production protocols, and regional compliance to secure market share.

Conclusion

The primary suppliers of Fluorodopa F-18 are a select group of specialized companies with entrenched GMP capabilities, comprehensive regulatory compliance, and extensive distribution networks. Notable market players include IBA Molecular, Jubilant Radiopharma, and Advanced Accelerator Applications, each contributing significantly to meeting the rising clinical demand for FDOPA PET imaging.

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Key Takeaways

• Reliable sourcing of FDOPA F-18 hinges on strict adherence to GMP standards, regulatory approvals, and robust distribution channels.
• Major global suppliers including IBA, Jubilant Radiopharma, and AAA dominate the market, with regional players in Asia-Pacific expanding presence.
• The short half-life necessitates strategic positioning of production facilities close to clinical centers or centralized distribution hubs.
• Advances in cyclotron technology and local production capabilities are shaping future supply dynamics.
• Stakeholders must weigh cost, regulatory landscape, and logistical factors when selecting suppliers for FDOPA.

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FAQs

1. What are the primary regulatory considerations for sourcing Fluorodopa F-18?
Suppliers must hold approvals from regulatory agencies like the FDA or EMA. Additionally, the radiotracer must meet GMP standards for purity, specific activity, and sterility to ensure safe clinical use.

2. How does the short half-life of FDOPA influence supply chain logistics?
With a half-life of approximately 110 minutes, FDOPA requires rapid distribution from production sites to imaging centers. This demands proximity to cyclotrons or efficient courier networks to minimize decay and ensure adequate dosing.

3. Are there regional differences in suppliers for FDOPA F-18?
Yes. North America and Europe have well-established GMP-certified providers like Jubilant Radiopharma and AAA. Asia-Pacific regions are increasingly developing local production capabilities with companies like Cyclomedica.

4. Can hospitals produce FDOPA on-site?
Hospitals equipped with cyclotrons and qualified radiochemistry labs can produce FDOPA locally, provided they meet regulatory requirements and maintain stringent quality control measures.

5. What are the future trends impacting FDOPA supply?
Emerging trends include decentralization via on-site cyclotron facilities, technological innovations increasing production efficiency, and strategic partnerships expanding distribution networks to meet rising demand for neuroimaging applications.

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References

[1] IBA Molecular Official Website. (2023). Radiopharmaceutical offerings.
[2] GE Healthcare. (2023). PETtrace cyclotrons and radiopharmaceutical production solutions.
[3] Jubilant Radiopharma. (2023). FDOPA supply and distribution services.
[4] European Medicines Agency. (2022). Radiopharmaceuticals: Regulatory requirements.
[5] Novartis AG. (2023). Advanced Accelerator Applications portfolio.