Bulk Pharmaceutical API Sources for IOTHALAMATE SODIUM I-125

Bulk Pharmaceutical API Sources for IOTHALAMATE SODIUM I-125

Vendor	Vendor Homepage	Vendor Sku	API Url
MuseChem		M083960
THE BioTek		bt-1194766
J&H Chemical Co.,ltd		JH179265
RR Scientific		R131146

Bulk Active Pharmaceutical Ingredient (API) Sources for: IOTHALAMATE SODIUM I-125

Last updated: July 27, 2025

Introduction

Iothalamate Sodium I-125, a radiocontrast agent used primarily in diagnostic imaging and radiopharmaceutical applications, necessitates sourcing high-purity active pharmaceutical ingredients (APIs). Ensuring the quality, compliance, and reliability of API suppliers is critical for healthcare providers and pharmaceutical manufacturers. As a radioactive iodine-labeled compound, Iothalamate Sodium I-125's procurement involves navigating a niche market shaped by strict regulatory standards, safety considerations, and specialized manufacturing processes. This report provides an exhaustive overview of the key bulk API sources for Iothalamate Sodium I-125, emphasizing their manufacturing capabilities, quality compliance, and market positioning.

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Market Landscape and Regulatory Considerations

The global market for radiopharmaceutical APIs, including Iothalamate Sodium I-125, is characterized by few specialized producers owing to the complexity of manufacturing processes, the necessity for stringent regulatory approval, and the handling of radioactive materials. Regulatory authorities such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and ICH (International Council for Harmonisation) set rigorous standards that API suppliers must meet, including Good Manufacturing Practice (GMP) compliance and proper radioactive material management.

Manufacturers must also adhere to guidelines on radiochemical purity, stability, bioavailability, and environmental safety. With the niche application and the limited number of licensed producers, market entry barriers remain high, reinforcing the importance of trusted API sources.

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Major API Suppliers for Iothalamate Sodium I-125

1. Jubilant Radiopharma (Jubilant Pharma)

Overview:
Jubilant Radiopharma, a division of Jubilant Life Sciences, is a prominent player in radiopharmaceutical manufacturing, supplying both diagnostic radiotracers and APIs, including Iothalamate Sodium I-125.

Capabilities:

• Fully GMP-compliant facilities dedicated to radiopharmaceutical APIs.
• Advanced isotope handling and containment systems ensuring safety and purity.
• Proven track record of producing high-purity iodinated compounds suitable for clinical applications.

Regulatory Status:

• Approved by major global health authorities, including the FDA and EMA, for production of radiochemicals.
• Possesses extensive documentation for quality assurance and regulatory compliance.

Market Position:

• One of the few API producers with integrated radiopharmaceutical manufacturing expertise.
• Supplies bulk APIs to both domestic and international pharmaceutical firms.

2. Nordion (Canada)

Overview:
Nordion, a subsidiary of Sterigenics, specializes in medical isotopes, including I-125, providing bulk radiochemicals for diagnostic and therapeutic use.

Capabilities:

• Extensive experience in isotope production, purification, and radiochemical formulation.
• Facilities equipped for large-scale production of high-specific-activity I-125.
• Rigorous quality control measures to ensure radiochemical purity and stability.

Regulatory Status:

• Complies with international standards and possesses licensing for isotope handling and transportation.
• Supplies APIs to numerous licensed radiopharmaceutical manufacturers globally.

Market Position:

• Key supplier for institutions requiring high-quality I-125 radiochemicals, including research and diagnostic utilities.

3. Eckert & Ziegler Radiopharma

Overview:
Eckert & Ziegler offers a portfolio of radiopharmaceutical supply solutions, including radionuclides and APIs, catering to clinical and research needs.

Capabilities:

• Certified GMP production lines for radiochemicals, featuring custom manufacturing of I-125 compounds.
• Expertise in isotope purification, with a focus on high-specific-activity iodine isotopes.

Regulatory Status:

• Approved facilities meeting European and American regulatory standards.
• Known for adherence to radiation safety protocols alongside pharmaceutical quality standards.

Market Position:

• A significant provider of radionuclide APIs with flexible production capacities tailored to customer specifications.

4. Isotope Technologies Dresden (ITD)

Overview:
ITD specializes in the production of medical isotopes and radiochemicals, including I-125, focusing on high-purity APIs used in diagnostics.

Capabilities:

• Innovative technology platform for isotope synthesis and purification.
• Extensive experience in producing radiochemicals under GMP conditions.
• Capable of custom batch manufacturing aligned with client specifications.

Regulatory Status:

• Holds licenses for radioactive material production and distribution in accordance with regional regulatory regimes.
• Maintains quality management systems aligned with ISO standards.

Market Position:

• A trusted supplier for European-based radiopharmaceutical companies and research institutions.

5. Lantheus Medical Imaging

Overview:
While primarily recognized for finished radiopharmaceuticals, Lantheus also supplies bulk radiochemical APIs, including iodine isotopes.

Capabilities:

• Integrated manufacturing for high-purity I-125 compounds.
• Focus on ensuring batch-to-batch consistency and regulatory adherence.

Regulatory Status:

• Certified under GMP, with proven compliance for international markets.

Market Position:

• A significant contributor to the global supply chain, particularly in North America and Europe.

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Emerging and Niche Suppliers

Several smaller or regional companies are developing capacity for I-125 APIs, driven by advances in isotope production technology and partnerships with research institutions. These include:

• ITG GmbH (Germany): Known for producing research-grade iodine isotopes with potential for clinical-grade API expansion.
• LIPA Radiopharma (India): Emerging provider focusing on affordable radiochemicals, including I-125.

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Challenges in API Sourcing for Iothalamate Sodium I-125

• Radiological Safety and Handling: API suppliers must operate under strict safety protocols, complicating manufacturing logistics.
• Regulatory Variability: Differences in regional licensing, export controls, and import restrictions influence supplier selection.
• Supply Chain Security: The niche market and limited production capacities mean that supply disruptions can significantly impact downstream pharmaceutical manufacturing.
• High Regulatory Barriers: Transitioning from research-scale production to GMP-compliant large-scale API manufacturing entails significant investment and validation efforts.

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Conclusion

The procurement of high-quality Iothalamate Sodium I-125 APIs is constrained to a select group of highly specialized suppliers. Major players like Jubilant Radiopharma, Nordion, Eckert & Ziegler, and ITD dominate this space, offering dependable, GMP-compliant, and regulatory-approved products. Given the complexities surrounding radiochemical production, partnerships with established suppliers are advisable to mitigate risks associated with supply disruptions, regulatory non-compliance, and safety concerns. As advances in isotope synthesis continue, emerging suppliers may broaden the market, but current capabilities remain concentrated among a handful of experts, emphasizing the importance of strategic sourcing and rigorous supplier validation.

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Key Takeaways

• Limited Suppliers: The I-125 API market is highly specialized, with few globally recognized providers meeting stringent quality and safety standards.
• Regulatory Compliance: Suppliers must demonstrate GMP compliance and possess licenses for radioactive material handling, influencing procurement decisions.
• Manufacturing Expertise: Successful sourcing depends on manufacturers’ technological capacity for high radionuclide purity and stability.
• Supply Chain Risks: The niche market's vulnerability to disruptions necessitates diversified supplier relationships and contingency planning.
• Emerging Markets: New entrants leveraging technological advancements may expand supply options but require careful validation.

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FAQs

1. What are the primary factors to consider when sourcing Iothalamate Sodium I-125 APIs?
Regulatory compliance, GMP certification, purity standards, manufacturing capacity, safety protocols, and supply reliability are critical considerations.

2. How does radiochemical purity impact the quality of I-125 APIs?
High radiochemical purity ensures accurate diagnostic imaging, minimal side effects, and compliance with regulatory standards, directly affecting patient safety and diagnostic efficacy.

3. Are there regional differences in API regulation for I-125?
Yes. Regulatory frameworks vary internationally, with the US, Europe, and Asia maintaining distinct licensing, safety, and environmental standards influencing supplier credentials and export/import processes.

4. Can emerging suppliers reliably replace established ones?
While technological advances enable new entrants, strict quality controls and regulatory approvals are necessary before they can reliably supply clinical-grade I-125 APIs at scale.

5. What are the risks of supply disruption in the I-125 API market?
Limited production capacity, regulatory hurdles, radioactive material scarcity, and safety concerns heighten risks, emphasizing the need for strategic stockpiling and supplier diversification.

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References

1. [1] Jubilant Radiopharma: Company Overview and Capabilities.
2. [2] Nordion: Radiopharmaceutical Radionuclide Production and Standards.
3. [3] Eckert & Ziegler Radiopharma: GMP Certification and Product Portfolio.
4. [4] International Atomic Energy Agency (IAEA): Guidelines on Production of Medical Isotopes.
5. [5] European Medicines Agency (EMA): Radiopharmaceutical Regulations and Compliance Standards.