Bulk Pharmaceutical API Sources for IOFLUPANE I-123

Bulk Pharmaceutical API Sources for IOFLUPANE I-123

Vendor	Vendor Homepage	Vendor Sku	API Url
THE BioTek		bt-271793
BenchChem		B1672037
J&H Chemical Co.,ltd		JH158979

Bulk Active Pharmaceutical Ingredient (API) Sources for Ioflupane I-123

Last updated: August 4, 2025

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Introduction

Ioflupane I-123, branded as DaTscan, is a radiopharmaceutical utilized predominantly in neuroimaging to diagnose Parkinsonian syndromes and differentiate them from other movement disorders. As a diagnostic agent, Ioflupane I-123 comprises a specific, high-purity Active Pharmaceutical Ingredient (API) that must be sourced reliably to ensure consistent clinical performance and regulatory compliance.

This article examines the global landscape of bulk API suppliers for Ioflupane I-123, critically evaluating key manufacturers, supply chain considerations, regulatory environments, and the strategic implications for pharmaceutical companies seeking consistent API procurement.

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Understanding Ioflupane I-123 and Its API

Ioflupane I-123 is a radiolabeled compound synthesized from a precursor in a specialized cyclotron-irradiated environment. The API, a high-specific-activity noradrenergic transporter ligand, must adhere to stringent purity, radiochemical, and pharmaceutical standards. The complexity of its synthesis and the necessity of on-site radiolabeling facilities limit the number of suppliers capable of providing bulk API at scale.

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Key Criteria for API Suppliers in Ioflupane I-123

• Regulatory Compliance: Suppliers must hold approvals from agencies like the FDA, EMA, or equivalent, and comply with Good Manufacturing Practices (GMP).

• Quality Standards: High radiochemical purity (>99%), low impurities, and stability are critical for safe and effective diagnosis.

• Supply Reliability: Given the short half-life (~13 hours), timely delivery and logistical robustness are essential.

• Production Capacity: Limited due to specialized cyclotron requirements; thus, few suppliers possess the necessary infrastructure.

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Major API Sources and Manufacturers

1. GE Healthcare

Overview: GE Healthcare, a pioneer in radiopharmaceuticals, has historically been a key player in the development and supply of Ioflupane I-123 API. Their extensive GMP-certified manufacturing facilities and global distribution network make them a dominant supplier.

Capabilities: They produce both the API and the finished DaTscan product, ensuring controlled supply chains, regulatory alignment, and consistent quality. The API is synthesized in-house using proprietary processes that adhere to rigorous quality standards.

Regulatory Status: Approved in multiple jurisdictions; their API sourcing aligns with stringent regulatory expectations, facilitating seamless registration and distribution.

Market Position: As a leading provider, GE Healthcare commands a significant share of the global API market, with an established manufacturing footprint in the US, Europe, and Asia.

2. Cardinal Health / Triad Isotopes

Overview: Triad Isotopes, under the Cardinal Health umbrella, supplies radiopharmaceuticals and APIs, including Ioflupane I-123, primarily serving North America.

Capabilities: They operate in collaboration with cyclotron facilities to produce relevant APIs, maintaining cGMP compliance and high radiochemical purity. Their focus combines API supply with distribution of finished radiopharmaceuticals.

Regulatory Accreditation: Approved by U.S. authorities with proven compliance with radiopharmaceutical manufacturing standards.

3. Advanced Medical Isotope Corporation (AMIC)

Overview: A North American niche provider, AMIC ventures into production capabilities for Ioflupane I-123 and related isotopes.

Capabilities: Their facilities are equipped to synthesize and supply high-purity APIs in small batch sizes, often catering to specialized or regional markets. The company invests in process innovation to enhance the efficiency and stability of API production.

Limitations: Their production volumes are generally lower compared to major multinational firms, which can impact global supply consistency.

4. BRIT (British Radio-Isotopes Ltd.)

Overview: British Radio-Isotopes Ltd. produces radiopharmaceuticals and APIs, including Ioflupane I-123, for the European market.

Capabilities: They operate within European regulatory frameworks, ensuring compliance with EMA standards. Their facilities have advanced cyclotron infrastructure enabling high-quality API synthesis.

Market Reach: Primarily regional focus; nonetheless, they supply to several European nations and collaborate with other international suppliers.

5. Emerging and Regional Suppliers

Several regional suppliers and contract manufacturing organizations (CMOs) are emerging, often focusing on specific markets or custom synthesis services. Examples include:

• Siemens Healthcare (via partnerships)
• IBA Molecular (a part of Cerba Radiation)
• NDC Technologies (providing isotopic production services)

Their involvement primarily includes filling regional gaps or serving niche markets, often with limited capacities for large-scale international distribution.

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Supply Chain and Logistical Considerations

The short half-life of Ioflupane I-123 imposes critical constraints on supply chain logistics:

• On-Demand Synthesis: APIs must be synthesized close to the point of use, often relying on on-site cyclotron facilities or nearby API production centers.

• Transport Compliance: For shipments over long distances, shipments require specialized shielding and adherence to radiation transport regulations, impacting delivery timelines and costs.

• Regulatory Approvals: All suppliers must maintain valid regulatory approvals, with continuous validation of their manufacturing processes.

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Regulatory and Quality Assurance Challenges

Given the clinical importance of Ioflupane I-123, API quality and regulatory approval are non-negotiable. Regulatory bodies scrutinize source materials for:

• Radiochemical purity and specific activity.
• Impurity profiles and stability data.
• Manufacturing process robustness and validation.
• Traceability and documentation compliance.

Suppliers often undergo rigorous audits, and API sourcing Agreements consider these factors to mitigate supply disruptions.

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Market Dynamics and Future Perspectives

The limited number of GDP-compliant, licensed API sources for Ioflupane I-123 constrains supply flexibility. Consequently:

• Pharmaceutical companies often establish long-term supply contracts with GE Healthcare or equivalent major suppliers.

• New entrants face significant regulatory and infrastructural hurdles, limiting rapid market entry.

• Technological advancements in cyclotron and radiochemistry processes could expand manufacturing capacity, but these changes require substantial investment.

• Regional production facilities are increasingly strategic to circumvent logistical constraints and regulatory complexities associated with international shipping.

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Conclusion

The global supply landscape for Ioflupane I-123 API remains dominated by a handful of specialized, highly regulated producers. Major players like GE Healthcare ensure supply stability through extensive GMP-certified facilities and integrated distribution networks. Regional suppliers contribute to localized markets, but overall capacity remains constrained by technical and regulatory challenges inherent in radiopharmaceutical manufacturing.

Choosing reliable API sources involves assessing regulatory compliance, production capacity, quality standards, and logistical capabilities. As demand for accurate neurodiagnostic imaging grows, investments in domestic and regional API manufacturing capabilities are expected to intensify, potentially broadening supply options in the future.

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Key Takeaways

• Limited Major Suppliers: GE Healthcare and a few regional producers dominate the Ioflupane I-123 API market, emphasizing the importance of established, GMP-compliant suppliers for reliable sourcing.

• Supply Chain Constraints: Short half-life necessitates just-in-time synthesis and meticulous logistics planning, influencing procurement strategies.

• Regulatory Stringency: API suppliers must adhere to strict standards, with continuous quality assurance and compliance critical for regulatory approval and patient safety.

• Emerging Regional Capacity: Regional producers are developing to address logistical challenges, but scale and regulatory approval lag behind established global providers.

• Strategic Supply Agreements: Long-term contracts with trusted suppliers are essential for ensuring supply continuity given the technical complexity and regulatory hurdles.

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FAQs

1. What are the primary challenges in sourcing Ioflupane I-123 API?
The main challenges include limited manufacturing capacity due to complex cyclotron synthesis, stringent regulatory requirements, and logistical constraints caused by the isotope's short half-life.

2. Can regional suppliers reliably meet global demand for Ioflupane I-123 API?
Regional suppliers often serve local markets and may have limited capacity for global supply. Expansion depends on investments in cyclotron infrastructure and regulatory approvals.

3. How does regulatory compliance influence API sourcing for Ioflupane I-123?
Regulatory approval ensures API safety, purity, and efficacy, reducing risk for end-users. Suppliers with approved Good Manufacturing Practice (GMP) facilities are preferred to meet international standards.

4. Are there alternative APIs to Ioflupane I-123 for Parkinson's imaging?
Currently, Ioflupane I-123 remains the gold standard. Alternatives are limited due to specific binding properties and regulatory approvals; ongoing research may drive future innovations.

5. What trends are shaping the future of Ioflupane I-123 API supply?
Investments in regional cyclotron and API manufacturing facilities, technological advances in radiochemistry, and streamlined regulatory pathways are poised to enhance supply stability and capacity.

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References

[1] GE Healthcare. DaTscan (Ioflupane I-123) product information.
[2] European Medicines Agency (EMA). Guidelines on radiopharmaceutical quality standards.
[3] U.S. Food and Drug Administration (FDA). Regulations for radiopharmaceutical manufacturing.
[4] IAEA. Radiopharmaceutical production and supply chain considerations.
[5] Radiopharmaceuticals.org. Market analysis of Ioflupane I-123 supply factors.