Bulk Pharmaceutical API Sources for sodium iodide i-123

Bulk Pharmaceutical API Sources for sodium iodide i-123

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		11954386
BenchChem		B1247706
THE BioTek		bt-1580549

Bulk Active Pharmaceutical Ingredient (API) Sources for: SODIUM IODIDE I-123

Last updated: July 31, 2025

Introduction

Sodium Iodide I-123 (NaI-123) is a radioactive iodine isotope utilized predominantly in diagnostic imaging, notably for thyroid scans and functional assessments of thyroid activity. Its precise sourcing and manufacturing are critical due to the stringent safety, regulatory, and quality standards associated with radioactive pharmaceuticals. Reliable bulk API sources are essential for pharmaceutical manufacturers and nuclear medicine providers aiming to ensure both regulatory compliance and optimal patient outcomes.

This article offers a comprehensive examination of global suppliers providing bulk I-123 Sodium Iodide, analyzing their manufacturing capacities, regulatory compliance, supply stability, and strategic considerations for stakeholders.

Regulatory and Quality Standards in I-123 API Procurement

The procurement of I-123 API must comply with international standards such as the U.S. Pharmacopoeia (USP), European Pharmacopoeia (EP), and Good Manufacturing Practices (GMP). Suppliers must demonstrate rigorous quality control, including radionuclidic purity, radiochemical purity, sterility, and stability. Additionally, compliance with local regulatory bodies (FDA, EMA, etc.) influences sourcing decisions.

Given the isotope's radiological nature, the supply chain involves specialized nuclear pharmacies and licensed manufacturers with accredited facilities capable of handling and processing radioactive materials safely.

Major Global Suppliers of I-123 Sodium Iodide API

1. Eckert & Ziegler Radiopharma GmbH

Overview: Eckert & Ziegler is a leading international manufacturer in radiopharmaceuticals, with extensive capabilities in producing bulk radioactive isotopes, including I-123 compounds. The company operates GMP-compliant production sites in Germany, offering high-purity Sodium Iodide I-123 for distribution globally.

Capabilities & Offerings:

• Certified for clinical use with proven radionuclidic and radiochemical purity.
• Supply chain integrated with nuclear pharmacies.
• Emphasizes safety and quality control with rigorous GMP adherence.

Market Position: Known for reliability and quality, Eckert & Ziegler supplies bulk I-123 to hospitals and radiopharmacies worldwide, with a steady supply chain backed by robust manufacturing capacity.

2. BRIT (Board of Radiation & Isotope Technology), India

Overview: A government-established entity in India, BRIT manufactures a variety of radioisotopes, including I-123. It operates under the Department of Atomic Energy and supplies to domestic and international markets.

Capabilities & Offerings:

• Produces high-purity Sodium Iodide I-123 suitable for medical imaging.
• Complies with international quality standards and possesses licensing for export.

Market Position: BRIT's strategic focus on cost-effective production makes it an attractive supplier, especially to emerging markets. Its quality standards align with international norms, though regulatory acceptance varies by region.

3. Jubilant Radiopharma (formerly NEOS Health)

Overview: Based in India, Jubilant offers a broad range of radiopharmaceuticals and bulk isotopes, including I-123 Sodium Iodide.

Capabilities & Offerings:

• GMP-certified facilities with advanced purification processes.
• Supplies both bulk and pre-filled kits for clinical use.

Market Position: Focuses on Southeast Asia, Middle East, and African markets, with capacity for large-scale production and consistent supply.

4. Eckert & Ziegler Neurotina GmbH (a subsidiary)

Overview: Specializes in radiotherapeutic isotopes but also provides diagnostics-grade I-123.

Capabilities & Offerings:

• Offers custom synthesis services for tailored isotopic formulations.
• Emphasizes high radionuclidic purity essential for diagnostic applications.

Market Position: Competitive for providers seeking customized bulk API solutions in diagnostic nuclear medicine.

5. Cyclolab (Hungary)

Overview: Cyclolab focuses on cyclotron-produced isotopes, including reactor or cyclotron-based I-123.

Capabilities & Offerings:

• Produces I-123 via cyclotron, ensuring high specific activity.
• Provides bulk quantity along with radiochemical purity documentation.

Market Position: Suitable for institutions with cyclotron facilities aiming for local production to reduce reliance on imports.

Supply Chain and Logistical Considerations

The radioactive nature of I-123 API necessitates specialized logistics involving licensed transport methods, adherence to International Air Transport Association (IATA) regulations, and secure handling. The half-life of I-123 (~13 hours) mandates rapid distribution, emphasizing the importance of reliable suppliers with proximity or efficient logistics networks.

Global supply is often affected by reactor availability, production capacity, regulatory approvals, and geopolitical factors. Manufacturers with integrated production-to-distribution systems provide more reliable supply chains to meet clinical demand.

Emerging Trends and Strategic Insights

• Local Production Initiatives: Countries with nuclear infrastructure are investing in domestic I-123 production to enhance supply independence amid global shortages.

• Alternative Production Methods: Cyclotron-based synthesis offers higher specific activity and reduces dependency on reactor-based production but requires significant capital investment.

• Regulatory Harmonization: Increasing efforts towards international standardization facilitate smoother import-export processes and broader supplier access for clinicians.

• Supply Diversification: Pandemic-related disruptions have underscored the importance of diversified sourcing strategies to mitigate supply risks.

Challenges in Sourcing Bulk I-123 API

• Radiological Safety Compliance: Ensuring suppliers meet stringent radiological safety protocols is vital to prevent contamination and ensure patient safety.

• Regulatory Barriers: Variations in approval processes across jurisdictions can delay procurement and distribution.

• Cost Factors: The high production and logistical costs associated with radioactive isotopes influence pricing and procurement decisions.

• Supply Stability: Limited number of specialized producers can create vulnerability to production disruptions, affecting clinical workflows.

Conclusion

While the global landscape for bulk Sodium Iodide I-123 API production remains specialized and somewhat concentrated, key suppliers like Eckert & Ziegler, BRIT, Jubilant Radiopharma, and Cyclolab provide reliable avenues for procurement. Prospective buyers should prioritize suppliers with robust GMP compliance, proven track record, and dependable logistics networks. As technological advancements and local production initiatives evolve, the availability and cost-effectiveness of I-123 are expected to improve, supporting broader adoption of diagnostic nuclear medicine.

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Key Takeaways

• Supplier Selection: Prioritize suppliers with established GMP compliance, proven radionuclidic purity, and reliable logistics to mitigate supply risks.

• Regulatory Alignment: Ensure suppliers' API conform to regional regulatory standards for seamless clinical integration.

• Strategic Sourcing: Diversify supply sources where possible, considering local production capabilities or cyclotron synthesis to reduce dependence on limited reactors.

• Logistics Planning: Account for the isotope's short half-life in procurement timelines and coordinate with licensed carriers for secure, compliant transportation.

• Future Outlook: Advances in cyclotron technology and increased domestic production may bolster supply reliability and reduce costs.

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FAQs

1. What are the key regulatory considerations when sourcing I-123 API?
   Suppliers must demonstrate compliance with GMP, provide documentation of radionuclidic and radiochemical purity, and adhere to licensing standards of local authorities like the FDA (USA) or EMA (Europe). Additionally, transportation must meet IATA standards for radioactive materials.

2. How does the half-life of I-123 impact supply chain logistics?
   With a half-life of approximately 13 hours, I-123 requires rapid production, transportation, and administration. Delays beyond a few hours can significantly diminish activity, making proximity to manufacturing sites and efficient logistics critical.

3. Are there domestic producers of I-123 in the United States?
   Currently, U.S.-based production of I-123 is limited and often relies on imports. Some manufacturers in Europe and Asia supply the U.S. market, emphasizing the importance of international logistics and regulatory compliance.

4. What technological advancements are influencing I-123 production?
   Cyclotron-based synthesis offers higher specific activity and potentially more reliable supply, reducing dependency on reactor-based production. Innovations in radiochemical purification also enhance purity standards.

5. What factors should radiopharmaceutical companies consider when establishing contracts with I-123 suppliers?
   Companies should assess supply stability, production capacity, regulatory compliance, quality assurance protocols, logistical arrangements, and pricing structures. Long-term contracts with flexible terms can mitigate supply disruptions.

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References

1. [1] Eckert & Ziegler Radiopharma GmbH. Product Portfolio and Quality Certifications.
2. [2] BRIT: Indian Society of Nuclear Medicine – Radiopharmaceuticals Division. Production Standards and Global Market Data.
3. [3] Jubilant Radiopharma. Company Profile and Regulatory Compliance.
4. [4] Cyclolab. Cyclotron-Produced Isotopes for Diagnostic Imaging.
5. [5] IAEA. Regulations for the Safe Transport of Radioactive Material.