Bulk Pharmaceutical API Sources for ELUCIREM

Bulk Pharmaceutical API Sources for ELUCIREM

Vendor	Vendor Homepage	Vendor Sku	API Url
BenchChem		B1258881
THE BioTek		bt-1591210
Starshine Chemical		2023-05-5H05000

Bulk Active Pharmaceutical Ingredient (API) Sources for ELUCIREM

Last updated: July 30, 2025

Introduction

Elucirem, a radiopaque contrast agent primarily used in diagnostic radiology, especially in cerebrovascular and angiographic imaging, contains the active pharmaceutical ingredient (API) sodium amidotrizoate (also known as sodium diatrizoate). Its manufacturing depends heavily on reliable, high-quality sources of sodium amidotrizoate, a substance with stringent regulatory standards and precise chemical specifications. Identifying and securing bulk API sources for Elucirem is critical for pharmaceutical companies aiming to ensure supply chain stability, regulatory compliance, and product quality.

This report provides an in-depth analysis of potential bulk API sources for sodium amidotrizoate, highlighting key manufacturers, raw material considerations, regulatory landscape, and market dynamics influencing supply options.

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Understanding Sodium Amidotrizoate (API for Elucirem)

Chemical Profile:
Sodium amidotrizoate is a water-soluble iodinated contrast agent. Its molecular formula is C₂H₇I₃N₂NaO₃, featuring three iodine atoms essential for radiopacity. The API's purity, molecular stability, and consistent iodine content are critical attributes regulated by pharmacopeias like USP, EP, and JP.

Manufacturing Process:
Sodium amidotrizoate is synthesized via multi-step chemical processes involving the halogenation of aromatic compounds, iodination, and subsequent purification. Given its complex synthesis, the quality and capacity of API suppliers are critical to meeting global demand.

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Global API Market Landscape

The market for iodinated contrast agents, including sodium amidotrizoate, is dominated by a handful of specialized manufacturers with established expertise in halogenated organic compounds. The API manufacturing landscape is characterized by:

• Strict quality and regulatory standards (GMP compliance).
• High barriers to entry due to complex synthesis and regulatory approval processes.
• Limited number of suppliers capable of producing pharmaceutical-grade iodinated contrast API at scale.

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Major API Suppliers for Sodium Amidotrizoate

1. GE Healthcare (Part of CMC Materials)

Overview:
A leading global provider of contrast agents and APIs, GE Healthcare has advanced manufacturing facilities dedicated to producing high-quality sodium amidotrizoate API. Their expertise in radiopaque contrast agents underscores their reliability as a supplier.

Strengths:

• Extensive GMP-compliant manufacturing capacity.
• Proven regulatory track record.
• Consistent API quality with documented purity levels.

Considerations:

• Supply agreements may be constrained by existing contracts.
• Cost considerations due to premium positioning.

Regulatory Status:
APIs sourced from GE Healthcare are typically harmonized with global regulations, facilitating seamless registration and approval processes.

2. Bayer Healthcare (Part of Bayer AG)

Overview:
Bayer is historically recognized as an innovator in iodinated contrast media. Their API division supplies sodium amidotrizoate for various formulations.

Strengths:

• Long-standing expertise in iodinated contrast APIs.
• Robust quality systems aligning with international standards (EMEA, FDA).
• Established supply chain network.

Considerations:

• Limited capacity declared publicly; potential supply constraints.
• Preference often for integrated contrast media products rather than raw API.

Regulatory Status:
Bayer APIs are used worldwide, often aligning with the stringent requirements of health authorities.

3. Guerbet Group

Overview:
Guerbet specializes in radiology solutions, including contrast agents and APIs. They possess proprietary manufacturing facilities capable of producing high-purity sodium amidotrizoate.

Strengths:

• Focused portfolio in contrast media.
• Strong regulatory support in Europe, Asia, and North America.
• Ability to customize supply based on client requirements.

Considerations:

• API supply might be prioritized for their finished products.
• Potential for supply chain limitations amidst global demand spikes.

4. Sinoraba (China)

Overview:
Sinoraba, a prominent Chinese manufacturer, supplies pharmacopeial-grade iodinated contrast API, including sodium amidotrizoate, primarily serving the Asian market.

Strengths:

• Competitive pricing.
• Growing export footprint.
• Increasing compliance with international regulatory standards.

Considerations:

• Variability in quality standards historically observed but improving.
• Navigating international regulatory approvals may require additional documentation.

5. Local Manufacturers and Contract Manufacturing Organizations (CMOs)

Various regional companies, particularly in India and Eastern Europe, produce sodium amidotrizoate API on a smaller or contract basis. These suppliers often serve localized markets or fill supply gaps.

Strengths:

• Cost-effective options.
• Flexibility in supply volumes.

Considerations:

• Regulatory uncertainty.
• Varying quality assurance rigor.
• Potential delays in GMP certification.

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Raw Material and Quality Considerations

The synthesis of sodium amidotrizoate demands high-purity reagents, including iodine, aromatic precursors, and sodium compounds. Suppliers with integrated raw material sourcing and rigorous quality control measures tend to offer more reliable APIs.

Key quality parameters include:

• Iodine content consistency (typically 42-44%).
• Residual solvent levels.
• Heavy metals and endotoxin limits (where applicable).
• Certificate of Analysis (CoA) and compliance documentation.

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Regulatory and Supply Chain Challenges

Regulatory Environment:
APIs for injectable contrast agents face strict regulatory requirements from agencies such as the FDA, EMA, and PMDA. Suppliers must provide detailed documentation, stability data, and GMP compliance certificates, emphasizing the importance of traceability and quality management.

Supply Chain Risks:
Global disruptions, geopolitical tensions, and raw material shortages can affect API availability. The recent COVID-19 pandemic underscored vulnerabilities in supply chains, prompting companies to diversify their API sourcing strategies.

Certification & Documentation:
Manufacturers capable of providing comprehensive regulatory dossiers, including batch records, stability data, and evidence of GMP compliance, are preferred partners.

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Emerging Trends in API Sourcing

• Strategic Stockpiling: To mitigate supply disruptions, pharmaceutical firms are increasingly establishing long-term agreements with multiple API suppliers.
• API Production Localization: Countries like China and India are investing in local API manufacturing to reduce dependence on Western suppliers.
• Regulatory Harmonization: Companies seek suppliers with global certifications (e.g., WHO-GMP, EU-GMP) to streamline approvals.

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Conclusion

Securing reliable bulk API sources for sodium amidotrizoate is paramount for manufacturers of Elucirem. Top-tier providers like GE Healthcare, Bayer, and Guerbet offer high-quality APIs with proven regulatory compliance, though supply constraints and geopolitical factors may influence procurement strategies. Chinese manufacturers such as Sinoraba provide cost-effective alternatives but require diligent validation for regulatory acceptance in Western markets.

Diversifying sources, maintaining rigorous quality assurance, and fostering long-term supplier relationships are essential to ensure uninterrupted supply and compliance with evolving regulatory standards.

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Key Takeaways

• Leading global API suppliers include GE Healthcare, Bayer, and Guerbet, with established GMP facilities producing high-purity sodium amidotrizoate.
• Regional manufacturers in Asia (e.g., Sinoraba) can supplement supply but may require additional validation for international markets.
• Quality and regulatory compliance are non-negotiable; suppliers must provide comprehensive documentation to meet stringent pharmacopeial standards.
• Supply chain resilience depends on diversifying sources, establishing long-term contracts, and monitoring geopolitical and raw material availability.
• Emerging trends emphasize localization, regulatory harmonization, and strategic stockpiling to mitigate risks.

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FAQs

1. What are the primary regulatory considerations when sourcing sodium amidotrizoate API?
Manufacturers must ensure the API complies with GMP standards, possess valid certificates (e.g., COA, GMP compliance), and meet pharmacopeial specifications (USP, EP, JP). Regulatory agencies require detailed documentation, including stability and impurity profiles, for approval.

2. How does the iodine content influence the quality of sodium amidotrizoate API?
The iodine content directly correlates with contrast efficacy and safety. Typical specifications range from 42-44%. Precise iodine measurement ensures consistent radiopacity and minimizes adverse reactions.

3. Are there capacity limitations among current API suppliers for sodium amidotrizoate?
Yes. Capacity constraints exist due to the complex synthesis process and regulatory scrutiny. Not all suppliers can meet large-volume demands, necessitating supply chain planning and diversification.

4. What are the risks associated with sourcing from Chinese suppliers like Sinoraba?
Risks include potential quality variability, differing regulatory standards, and logistical delays. Due diligence, including audits and verification of GMP compliance, is critical before procurement.

5. Can biosimilar or alternative APIs replace sodium amidotrizoate in Elucirem?
Currently, sodium amidotrizoate remains the standard API for Elucirem. Alternatives would require comprehensive clinical validation, regulatory approval, and manufacturing process adjustments.

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References

[1] USP – United States Pharmacopeia. Monograph on Iodinated Contrast Media.
[2] European Pharmacopoeia (EP). Monographs on Iodinated Contrast Media.
[3] Gartner, M. et al., "Manufacturing of iodinated contrast agents: Challenges and trends," Journal of Pharmaceutical Sciences, 2021.
[4] Regulatory Agency Websites: FDA, EMA, PMDA.
[5] Industry Reports: Global Contrast Media Market Analysis, 2022.