Bulk Pharmaceutical API Sources for FLUORODOPA F18

Bulk Pharmaceutical API Sources for FLUORODOPA F18

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		56494
ABI Chem		AC1L1L5L
Chemieliva Pharmaceutical Co., Ltd		PBCM1471592
THE BioTek		bt-268340

Bulk Active Pharmaceutical Ingredient (API) Sources for: Fluorodopa F18

Last updated: July 30, 2025

Introduction

Fluorodopa F18 (2-deoxy-2-fluoro-D-tyrosine, commonly known as FDOPA F18) is a radiopharmaceutical integral to positron emission tomography (PET) imaging, especially for neurological disorders such as Parkinson’s disease and neuroendocrine tumors. Its unique properties, characterized by high specificity for dopaminergic neurons, make it a vital diagnostic tool in nuclear medicine. Ensuring secure, reliable, and compliant sources for pharmaceutical-grade Fluorodopa F18 API is critical for healthcare providers, manufacturers, and supply chain stakeholders.

Understanding Fluorodopa F18 API

Fluorodopa F18 is synthesized as a radiolabeled compound, where the radioactive isotope Fluorine-18 (^18F) is incorporated into the molecular structure of DOPA. This process necessitates sophisticated production capabilities, typically involving cyclotrons to generate ^18F, and meticulous chemical synthesis procedures to produce the API in a form suitable for pharmaceutical use. The API’s short half-life (~110 minutes for ^18F) imposes particular logistical and sourcing considerations, emphasizing proximity to production facilities.

---

Global Suppliers and Manufacturing Landscape

1. Key Manufacturers of Fluorodopa F18 API

Multiple specialized contract manufacturing organizations (CMOs) and radiopharmaceutical producers operate globally, with some vertically integrated into the supply chain to produce the API from cyclotron facilities. Prominent names include:

• PETNET Solutions (a Siemens Healthineers company): Operates production facilities in North America and Europe, capable of synthesizing fluorodopa F18 on demand, primarily for distribution within their network. Their supply chain is tightly controlled, emphasizing quality and compliance.

• Eckert & Ziegler Radiopharma: A known provider of radiopharmaceuticals, including FLUORODOPA F18, with facilities across Europe. They offer both pre-synthesized doses and API raw material supplies to licensed commercial partners.

• IBA Molecular (a part of Ion Beam Applications Group): Provides cyclotron services and radiopharmaceutical production across Europe, including fluoro-derivatives. Their services extend to supplying API to licensed manufacturers.

• NorthStar Medical Radioisotopes: Primarily focused on isotope production, they also engage in radiopharmaceutical synthesis and API supply, particularly in North America.

• Advanced Accelerator Applications (a Novartis company): Engaged in the development and distribution of radiopharmaceuticals, with production sites capable of API synthesis.

2. Regional Considerations

• North America: The U.S. Food and Drug Administration (FDA) strictly regulates radiopharmaceutical production, with major suppliers including GE Healthcare and Siemens Healthineers.

• Europe: The European Medicines Agency (EMA) and national authorities oversee GMP compliance. Companies like Eckert & Ziegler and IBA are prominent.

• Asia-Pacific: Emerging providers in Japan, South Korea, and China are expanding their capabilities, but regulatory and quality standards vary.

3. API Quality Standards and Regulatory Compliance

Quality is paramount. Sourcing Fluorodopa F18 API requires adherence to Good Manufacturing Practice (GMP) standards, with license and certification from relevant regulatory bodies. Suppliers must provide comprehensive documentation, including batch records, stability data, and compliance certificates to ensure safety and efficacy.

4. Supply Chain Constraints and Considerations

Given the isotope’s short half-life, rapid logistics from production sites to end-users is essential. Many suppliers operate regional cyclotrons that produce F18 on-site or nearby, limiting external sourcing options to integrated or vertically aligned companies. This often results in a limited number of suppliers capable of delivering at scale, especially during high demand periods.

5. Contractual and Commercial Relationships

Businesses should prioritize establishing long-term agreements with verified suppliers possessing validated GMP processes. Due diligence involves auditing manufacturing facilities, reviewing compliance documentation, and assessing batch consistency.

---

Emerging Trends and Future Outlook

• On-demand cyclotron-based production: Increasing investments in regional cyclotron infrastructure will enhance supply stability and reduce dependency on centralized manufacturing.

• Automation and digitization: Adoption of automated synthesis modules reduces contamination risk and improves yields, aiding in consistent API supply.

• Regulatory harmonization: Efforts by international agencies aim to streamline authorization pathways, potentially easing the entry of new API suppliers into the market.

• Alternative production methods: Research into novel synthesis pathways and isotope generator-based production may diversify supply sources over the coming decade.

---

Key Takeaways

• Limited global suppliers specialize in Fluorodopa F18 API, concentrated mainly in North America, Europe, and some parts of Asia.

• Proximity to cyclotron facilities is critical due to the isotope’s short half-life, constraining supply chain options.

• Regulatory compliance and GMP standards are mandatory; partnerships should involve due diligence and thorough quality assessments.

• Supply chain stability relies heavily on regional infrastructure, making localized partnerships preferable for dependable API sourcing.

• Emerging innovations—such as regional cyclotron hubs and automated synthesis—will likely expand and stabilize future API sources.

---

FAQs

1. What are the main factors influencing the availability of Fluorodopa F18 API?
Availability depends on proximity to cyclotron facilities, regulatory approval, GMP compliance, and logistical efficiencies due to the isotope’s short half-life.

2. Which regions have the most established sources of Fluorodopa F18 API?
North America and Europe possess the most developed supply infrastructure, with several GMP-certified producers and regional cyclotron facilities.

3. How does regulatory compliance impact API sourcing?
Regulatory standards ensure safety and efficacy; non-compliant sources pose significant risks, hence only GMP-certified APIs are acceptable for pharmaceutical use.

4. Can I source Fluorodopa F18 API directly from any manufacturer?
Access typically requires partnerships with licensed suppliers, as direct sales are limited to approved entities under strict regulatory oversight.

5. Are there any upcoming innovations that could broaden API supply options?
Yes. Advances in regional cyclotron deployment, isotope generator technology, and automated synthesis processes are expected to diversify and stabilize future API sources.

---

References

[1] IAEA. (2021). "Production of radiopharmaceuticals." International Atomic Energy Agency.

[2] FDA. (2022). "Guidance for Industry: Radiopharmaceuticals." U.S. Food and Drug Administration.

[3] EMA. (2021). "Guideline on radiopharmaceuticals." European Medicines Agency.

[4] Eckert & Ziegler Radiopharma. Official Website.

[5] IBA Group. Official Website.

[6] PETNET Solutions. Official Website.

[7] Novartis Advanced Accelerator Applications. Official Website.