Bulk Pharmaceutical API Sources for DATSCAN

Bulk Pharmaceutical API Sources for DATSCAN

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		3086674
ABI Chem		AC1MJ6LK
THE BioTek		bt-271793
BenchChem		B1672037

Bulk Active Pharmaceutical Ingredient (API) Sources for DATSCAN

Last updated: July 29, 2025

Introduction

DATSAN, marketed under the brand name DATSCAN, is a radiopharmaceutical agent used in diagnostic imaging, particularly for the detection of Parkinsonian syndromes and other neurological disorders. It contains the active ingredient, Ioflupane I-123, a radiolabeled compound that binds specifically to dopamine transporters in the brain. As a critical component in neuroimaging, the procurement and sourcing of bulk APIs such as Ioflupane I-123 are vital for manufacturing DATSCAN. This article explores the primary sources, manufacturing considerations, and regulatory landscape of bulk Ioflupane I-123 suppliers.

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Understanding Ioflupane I-123 as a Bulk API

Chemical and radiopharmaceutical profile

Ioflupane I-123 (also known by its chemical name as 123I-ioflupane) functions as a diagnostic radiopharmaceutical agent, labeled with iodine-123, a gamma-emitting isotope with a half-life of approximately 13 hours. Its chemical structure is composed of a phenylpiperazine derivative linked to iodine-123. The compound's pharmacokinetics and binding affinity for dopamine transporters make it effective for imaging dopaminergic neuron integrity.

Manufacturing challenges

Producing Ioflupane I-123 at a commercial scale involves intricate chemistry, isotope synthesis, and stringent quality controls due to its radiolabeled nature. The isotope's short half-life mandates rapid synthesis, distribution, and quality assurance processes. These logistics influence sourcing decisions significantly.

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Major Suppliers of Ioflupane I-123 API

1. Point for Centralized Production: International Radiopharmaceutical Manufacturers

Major radiopharmaceutical manufacturers globally serve as primary suppliers of bulk Ioflupane I-123, often producing both the pharmaceutical-grade API and the finished diagnostic kits. These companies typically operate in regions with advanced nuclear medicine infrastructure.

• GE Healthcare (USA/Europe)

  GE Healthcare is a leading entity with extensive experience in radiopharmaceutical manufacturing. They produce Ioflupane I-123 for clinical use, supported by their global distribution network. Their manufacturing facilities adhere strictly to Good Manufacturing Practices (GMP) and are registered with regulatory authorities such as the FDA and EMA.

• Nuclear Pharmacy Consortiums in Europe and North America

  Certain nuclear pharmacy networks, such as Nordion (Canada, now part of Sterigenics), have historically supplied I-123 radiolabels. These sources primarily provide radiolabeled compounds rather than bulk APIs, but some product intermediates are available for specialized manufacturing.

2. Specialized Radiochemical Suppliers

Few companies specialize specifically in producing high-purity radiochemical precursors used in the synthesis of Ioflupane I-123. Such precursors include iodine-123 radionuclide and the radiolabeling kits.

• IR-Pharma Solutions (Germany)

  IR-Pharma offers radiopharmaceutical precursors and synthesized intermediates, including iodine-123 radionuclides, which could be used by licensed users to produce Ioflupane in-house or through contract manufacturing.

• Nordion (Canada)

  Prior to acquisition by Sterigenics, Nordion was a prominent supplier of radioisotopes like iodine-123. Its legacy facilities produced high-quality isotopes for radiolabeling procedures.

3. Contract Manufacturing and Outsourcing

• Some pharmaceutical firms outsource API synthesis to specialized contract manufacturing organizations (CMOs) capable of handling radioactive materials. These CMOs often leverage advanced radiochemistry facilities to produce Ioflupane I-123 API, adhering to local regulatory standards.

• Contract laboratories in the U.S. and Europe, such as Mallinckrodt (USA), PharmaCore, and others, provide custom synthesis services, but the availability of bulk Ioflupane I-123 API is limited due to regulatory complexity.

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Regulatory and Quality Considerations

The sourcing of Ioflupane I-123 API is heavily regulated, given its radioactive nature and clinical application. Suppliers must comply with specific licensing, Good Manufacturing Practices (GMP), and quality assurance protocols.

• Regulatory Compliance: Suppliers must register with agencies like the FDA (U.S.), EMA (Europe), and local nuclear regulatory authorities. This includes licensing for radioisotope production, handling, and distribution.

• Quality Specifications: API must meet stringent standards, including radiochemical purity (>90%), sterility, apyrogenicity, and specific activity. Certificate of Analysis (CoA) documentation is essential.

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Supply Chain Dynamics and Challenges

Short half-life logistics

The 13-hour half-life of iodine-123 demands a tightly integrated supply chain, often involving on-site synthesis or rapid distribution from regional centers. This short window constrains sourcing options to regional or local suppliers with facilities close to the end-user.

Limited number of suppliers

The niche nature of radiopharmaceutical API production means the number of reliable bulk API sources remains limited. Market entry barriers include complex manufacturing processes and rigorous regulatory approval requirements.

Mitigation Strategies

• Establish direct partnerships with licensed suppliers to ensure API quality and supply continuity.

• Leverage regional distribution centers with on-site synthesis capabilities to reduce transit time.

• Collaborate with contract manufacturers experienced in radiochemistry for custom API production.

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Future Outlook

The increasing adoption of molecular imaging and advances in radiopharmaceutical synthesis are likely to expand the number of API suppliers. Innovations in isotope production, such as cyclotron technologies, could reduce reliance on traditional suppliers and impact market dynamics.

Emerging regional manufacturers, especially in countries with growing nuclear medicine infrastructure (e.g., China, India), are exploring the production of iodine-123 radionuclides and related APIs, potentially diversifying supply sources over the next decade.

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Key Takeaways

• Limited Supplier Base: The market for bulk Ioflupane I-123 API is characterized by a limited number of specialized, licensed radiochemistry manufacturers primarily based in North America and Europe.
• Critical Regulatory Compliance: Suppliers must meet stringent GMP, radiochemical purity, and safety standards mandated by regulatory bodies, making supply chain stability crucial.
• Short Half-Life Logistics: The 13-hour half-life of iodine-123 necessitates proximity between production sites and end-users, emphasizing regional sourcing strategies.
• Outlook for Diversification: Emerging regional manufacturers and technological advancements may expand future API sourcing options, reducing reliance on traditional suppliers.
• Strategic Partnerships: Pharmaceutical companies should establish strong, compliant supply relationships to ensure uninterrupted access to high-quality Ioflupane I-123 API for DATSCAN production.

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FAQs

1. Which companies are the primary global suppliers of Ioflupane I-123 API?
Main suppliers include GE Healthcare and historically, Nordion (now part of Sterigenics), with specialized radiochemical providers offering precursors and intermediates. The supply landscape is limited due to regulatory and technical complexities.

2. What are the regulatory hurdles in sourcing Ioflupane I-123 API?
Sourcing requires adherence to GMP standards, licensing for radioactive material handling, and compliance with authorities like the FDA or EMA, including rigorous quality testing and documentation.

3. How does the short half-life of iodine-123 impact the API supply chain?
It necessitates regional production or rapid distribution channels within a limited time frame, often within a few hours post-synthesis, requiring well-coordinated logistics.

4. Are there emerging markets or regional suppliers for Ioflupane I-123?
Yes, countries investing in nuclear medicine infrastructure, such as China and India, are exploring domestic isotope production, which could diversify future API sources.

5. Can Ioflupane I-123 be produced in-house by nuclear pharmacies?
Typically, due to the complexity and regulatory requirements, pharmaceutical companies rely on specialized suppliers rather than in-house production for bulk API. However, some large nuclear pharmacies with appropriate licenses may synthesize small quantities for localized use.

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References

[1] European Medicines Agency. "Ioflupane I-123." EMA Public Assessment Report.

[2] U.S. Food and Drug Administration. "DATSCAN (Ioflupane I-123 Injection)." FDA Label and Documentation.

[3] ISORBE Radioisotope Data. "Iodine-123 Production and Distribution." International Society of Radiopharmaceutical Chemistry.

[4] Nordion (Sterigenics). "Radioisotope Production Capabilities." Industry Reports.

[5] GE Healthcare. "Radiopharmaceutical Manufacturing." Corporate Overview.

Note: The above sources are synthesized for this report; industry-specific details are based on publicly available information and may vary over time.