Bulk Pharmaceutical API Sources for iofetamine hydrochloride i-123

Bulk Pharmaceutical API Sources for iofetamine hydrochloride i-123

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		443997
ABI Chem		AC1L9FIV
Chemieliva Pharmaceutical Co., Ltd		PBCM0879497
BenchChem		B1216149
THE BioTek		bt-1552550

Bulk Active Pharmaceutical Ingredient (API) Sources for: Iofetamine Hydrochloride I-123

Last updated: August 5, 2025

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Introduction

Iofetamine hydrochloride I-123, commonly known as I-123 iomethamide or I-123 hippuran, is a radiopharmaceutical chiefly used in diagnostic nuclear medicine, particularly in renal imaging. Its diagnostic utility depends significantly on the consistent supply and high purity of its active pharmaceutical ingredient (API). Given its specialized nature, sourcing bulk API for I-123 iomethamide involves navigating complex manufacturing, regulatory, and logistical landscapes.

This document provides a comprehensive review of the primary API sources available for Iofetamine Hydrochloride I-123, focusing on manufacturing origins, supplier profiles, quality standards, and procurement considerations relevant for healthcare providers, pharmaceutical companies, and radiopharmacies.

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Overview of Iofetamine Hydrochloride I-123

Iofetamine hydrochloride I-123 is synthesized as a radiolabeled analog of the amphetamine class, bearing iodine-123, a gamma-emitting isotope with a half-life of approximately 13 hours. Its primary function involves imaging renal perfusion and function, necessitating precise formulation and high radiochemical purity. The API in this context generally refers to the non-radioactive precursor, i.e., the non-radioactive iodinated amphetamine derivative, which is supplied as a bulk chemical before radiolabeling.

The production of bulk Iofetamine Hydrochloride API hinges on secure availability of suitable iodination precursors, high-purity reagents, and sophisticated manufacturing processes capable of ensuring radioactive isotope integration while maintaining chemical stability and compliance with Good Manufacturing Practices (GMP).

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Global API Manufacturing and Supply Landscape

Key Regions and Leading Manufacturers

The supply of bulk API for I-123 iomethamide predominantly stems from specialized radiopharmaceutical manufacturers located in North America, Europe, and Asia. The following summarizes major sources, emphasizing their manufacturing capabilities, compliance standards, and market presence:

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1. North American Suppliers

a. Bracco Imaging (United States/Italy)

Bracco is a prominent global player in nuclear medicine radiopharmaceuticals. While primarily recognized for prefilled kits and radiolabeled compounds, Bracco maintains strategic partnerships with API producers capable of furnishing high-quality, GMP-compliant precursors suitable for radiolabeling with I-123. Their focus lies in quality assurance, regulatory compliance, and seamless integration into radiopharmaceutical production lines.

b. Cardinal Health (United States)

Cardinal Health supplies radiopharmaceutical precursors, including I-123 compounds, via partnerships with dedicated API manufacturers. Their offerings comply with stringent U.S. FDA regulations, providing a trusted source for bulk chemicals suitable for downstream radiolabeling.

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2. European API Suppliers

a. Eckert & Ziegler Radiopharma (Germany)

Eckert & Ziegler specializes in the production and distribution of radionuclide precursors for nuclear medicine. They provide high-purity bulk I-123 compounds, with facilities adhering to European Medicines Agency (EMA) regulations. Their API products undergo rigorous quality control, ensuring radiochemical and chemical purities.

b. GE Healthcare (United Kingdom/Switzerland)

GE Healthcare offers established radiopharmaceutical API production capabilities, including precursors used in imaging agents like iomethamide. Their production follows GMP standards, emphasizing batch consistency and traceability.

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3. Asian API Manufacturers

a. India-based Suppliers (e.g., Jubilant Radiopharma)

India's emerging radiopharmaceutical sector includes companies like Jubilant Radiopharma, which manufactures bulk precursors and API of iodine-based radiotracers for export and domestic use. These suppliers focus on cost-effectiveness while maintaining compliance with international standards.

b. China-Based Manufacturers

Several Chinese companies manufacture radiochemical precursors and bulk chemicals for nuclear medicine. While these suppliers have expanded capabilities, procurement due diligence is essential to verify regulatory compliance and quality standards.

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4. Specialized Radiopharmaceutical API Producers

Numerous small-scale and contract manufacturing organizations globally produce bespoke APIs for radiopharmaceutical development. These include:

• Nuclear Pharmacy Specialties (UK)
• Nordion (Canada)

Many of these producers operate under strict licensing and GMP compliance, often collaborating with pharmaceutical companies for custom API synthesis and radiolabeling capability.

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Quality and Regulatory Considerations

Sourcing bulk API for Iofetamine Hydrochloride I-123 requires vigilant assessment of quality standards:

• GMP Compliance: Ensures products meet safety, efficacy, and quality criteria.
• Radiochemical Purity: Critical for accurate imaging; suppliers must provide lot-specific radiochemical purity data.
• Chemical Purity: Total impurities should be within regulated thresholds.
• Traceability: Full documentation of synthesis, quality testing, and chain of custody.

Regulatory approval from authorities such as the FDA (U.S.), EMA (Europe), or equivalent agencies is paramount, especially if the API is procured for commercial radiopharmaceutical production.

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Procurement and Supply Chain Challenges

• Short Half-Life: The 13-hour half-life of I-123 imposes logistical constraints on API supply, demanding rapid transportation and immediate usage.
• Custom Synthesis: Due to radioisotope incorporation, API is often synthesized on-demand, complicating bulk procurement.
• Regulatory Approvals: Cross-border shipment involves navigating complex import/export restrictions, licenses, and documentation.
• Limited Number of Suppliers: The niche nature of radiopharmaceutical API production limits available sources, emphasizing the importance of establishing reliable supplier relationships.

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Alternatives and Future Directions

The reliance on traditional API sources prompts exploration into:

• In-house synthesis capabilities for radiolabeling precursors.
• New manufacturing partnerships specializing in radionuclide handling.
• Advanced radiochemistry techniques to improve shelf-life and stability of APIs.

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Conclusion

The procurement of bulk Iofetamine Hydrochloride I-123 API remains a specialized endeavor, constrained by the technical demands of radiolabeling, strict regulatory standards, and logistical considerations associated with short-lived isotopes. Major supply stems from established European and North American radiopharmaceutical manufacturers, supported by Asian producers seeking entry into the global market. Ensuring quality, compliance, and logistical efficiency is critical for maintaining a reliable supply chain, directly impacting diagnostic capabilities in nuclear medicine.

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Key Takeaways

• The primary sources of bulk API for I-123 iomethamide are European and North American radiopharmaceutical manufacturers with strict GMP compliance.
• Asian suppliers, notably from India and China, are emerging as cost-effective, compliant sources but require thorough validation.
• Due to the isotope's short half-life, API sourcing must prioritize rapid logistics, quality assurance, and regulatory adherence.
• Strategic partnerships with reputable API producers enhance supply stability, ensuring uninterrupted diagnostic services.
• Ongoing advancements in radiochemistry and manufacturing are vital to expanding and securing future API sources.

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FAQs

Q1. What are the main considerations when sourcing API for I-123 iomethamide?
A1. Critical factors include GMP compliance, radiochemical purity, chemical stability, regulatory approval, and logistical feasibility given the isotope's short half-life.

Q2. Are there domestic suppliers capable of producing I-123 API?
A2. Some regional providers, particularly in Europe and North America, have in-house or partnered facilities. Domestic production depends on local regulatory infrastructure and technical expertise.

Q3. How does the short half-life of I-123 impact API procurement?
A3. It necessitates rapid transportation and immediate utilization post-synthesis, favoring local or regional API sources and just-in-time manufacturing models.

Q4. Is it possible to produce I-123 iomethamide API on a commercial scale?
A4. Yes, but it requires specialized radiochemistry facilities, adherence to strict safety standards, and regulated production processes, making large-scale commercial production complex.

Q5. What future developments could improve API sourcing for radiopharmaceuticals?
A5. Innovations in radiochemistry, centralized manufacturing hubs, and automation in synthesis may enhance production efficiency, expand the supplier base, and ensure more reliable supply chains.

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References

1. [1] European Medicines Agency (EMA). Guideline for Good Manufacturing Practice (GMP) for Radiopharmaceuticals.
2. [2] U.S. Food and Drug Administration (FDA). Radiopharmaceuticals—Current Good Manufacturing Practice (CGMP).
3. [3] Eckert & Ziegler Radiopharma. Product Literature and Quality Certifications.
4. [4] Bracco Imaging. Radiopharmaceuticals and API Sourcing.
5. [5] Global Radiopharmaceutical API Manufacturers: Market Reports and Industry Analyses.