Bulk Pharmaceutical API Sources for IOXILAN

Bulk Pharmaceutical API Sources for IOXILAN

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		3743
ABI Chem		AC1L1GM2
ChemMol		44010108
ChemTik		CTK8F1279
AKos Consulting & Solutions		AKOS016014026
Chembase.cn		171726

Bulk Active Pharmaceutical Ingredient (API) Sources for IOXILAN

Last updated: July 27, 2025

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Introduction

Ioxilan, marketed under the brand name IOXILAN, is a nonionic, water-soluble contrast agent utilized in diagnostic radiology, specifically for angiography and computed tomography (CT) imaging. As a diagnostic drug, Ioxilan’s efficacy and safety hinge on high-quality Active Pharmaceutical Ingredients (APIs). Ensuring a reliable supply chain of bulk API sources remains crucial for manufacturers, healthcare providers, and stakeholders involved in the production and distribution of IOXILAN.

This report provides a comprehensive overview of potential bulk API sources for Ioxilan, examining manufacturing capabilities, regulatory considerations, global supply landscape, and key players committed to delivering high-purity APIs compatible with pharmaceutical standards such as USP, EP, and JP.

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Overview of Ioxilan API Manufacturing

Ioxilan is synthesized through complex multi-step organic processes involving specialized intermediates and halogenated compounds. The API's synthesis demands strict control over stereochemistry, impurity profiles, and purity levels to meet pharmacopeia standards for injectable drugs. Consequently, sourcing APIs depends not only on volume capabilities but also on adherence to cGMP (current Good Manufacturing Practice) regulations, quality assurance, and traceability.

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Global API Suppliers for Ioxilan

1. Major Pharmaceutical API Manufacturers

a) North America

• Baxter International: A leading provider of contrast agents, Baxter has extensive capabilities in manufacturing iodinated contrast media, including high-quality APIs. Their manufacturing facilities are FDA-approved, with proven adherence to cGMP standards, ensuring high purity levels.

• Thermo Fisher Scientific: Offers manufacturing services through its contract manufacturing division, particularly for complex APIs including iodinated contrast agents. They possess infrastructure for large-scale synthesis and rigorous quality control.

b) Europe

• GE Healthcare: Known for developing and manufacturing imaging contrast media, GE Healthcare has a robust API supply chain with facilities in Europe. They produce iodinated contrast agents, including Ioxilan, with a focus on safety and purity.

• Boehringer Ingelheim: While primarily focused on pharmaceuticals, they have capabilities in synthesizing radiopaque contrast agents and APIs, maintaining rigorous European pharmacopeia compliance.

c) Asia-Pacific

• Sinopec: A major Chinese chemical company with capabilities for producing specialty chemicals and APIs, including iodinated compounds suitable for contrast media.

• Suzhou Ankem: A Chinese biotechnology firm with experience in manufacturing medical-grade APIs, including the synthesis of iodinated contrast agents compliant with international standards.

• Jiangsu Hengrui Medicine Co., Ltd.: An emerging API manufacturer with increasing capacity in specialized APIs for diagnostic imaging agents.

2. Contract Manufacturing and Custom Synthesis

Contract manufacturing organizations (CMOs) such as Everest Medicines, WuXi AppTec, and Chiral Quest offer bespoke synthesis services. These firms typically serve as bridge suppliers or development partners, capable of scaling API production under strict regulatory compliance.

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Regulatory and Quality Considerations

Given the injectable nature of IOXILAN, the API source must demonstrate compliance with relevant pharmacopoeias (USP, EP, JP), and possess necessary certifications such as FDA approval, European EMA Certification, or PMDA approval in Japan. Prior to procurement, manufacturers must verify:

• Good Manufacturing Practice (GMP) certification
• Batch-to-batch consistency
• Traceability and documentation
• Certification of analysis (CoA) confirming impurity levels, residual solvents, endotoxins

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Emerging Trends in API Sourcing for Contrast Media

• Localization and Diversification: To mitigate supply chain disruptions, companies increasingly diversify suppliers across regions, emphasizing local manufacturing in North America, Europe, and Asia.

• Advanced Synthetic Techniques: The development of more efficient, environmentally friendly synthetic processes reduces manufacturing complexity and cost, expanding the pool of API suppliers.

• Regulatory Harmonization: International standards (ICH, WHO) facilitate global acceptance of APIs from diverse sources, enabling broader procurement options.

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Key Players and Their Strategic Positions

Supplier	Region	Certifications	Specialization	Remarks
Baxter International	North America	FDA, cGMP	Iodinated contrast APIs	Extensive capacity, proven quality
GE Healthcare	Europe	EMA, cGMP	Imaging contrast agents	Established global supply chain
Sinopec	Asia	NMPA	Specialty iodinated chemicals	Cost-effective bulk options
WuXi AppTec	Asia	cGMP	Custom API synthesis	Flexible production capabilities
Boehringer Ingelheim	Europe	EMA, cGMP	Contrast media APIs	R&D and manufacturing expertise

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Challenges and Future Outlook

Despite the presence of multiple API suppliers, challenges persist:

• Supply Chain Disruptions: Political factors, regulatory delays, or raw material shortages can impact availability.
• Regulatory Hurdles: Variations in country-specific API registration requirements may slow approval processes.
• Quality Assurance: Maintaining consistency at scale requires rigorous quality management systems.

Future prospects highlight the importance of vertical integration in contrast agent manufacturing, investment in green chemistry, and the expansion of regional API hubs to enhance supply resilience. Continuous innovation in synthetic routes could foster new suppliers, reducing dependency on traditional players.

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Conclusion

Reliable bulk API sourcing for Ioxilan hinges on a nuanced evaluation of manufacturing capacity, compliance, and quality standards. Major global industry players—such as Baxter, GE Healthcare, and Sinopec—offer robust supply options aligned with international regulatory requirements. Developing diversified supply chains and embracing innovative synthesis techniques will be vital in addressing future demand fluctuations and ensuring the continued availability of high-grade APIs for diagnostic imaging.

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Key Takeaways

• Secure API sourcing for Ioxilan demands adherence to cGMP standards, rigorous quality control, and regulatory compliance across regions.
• Major global manufacturers, especially in North America, Europe, and Asia, provide scalable, compliant API supplies.
• Contract manufacturing organizations serve as flexible partners for custom synthesis and scale-up.
• Diversification and regionalization of supply chains help mitigate risks associated with geopolitical or logistical disruptions.
• Innovation in synthesis methods and regulatory harmonization will shape the future landscape of Ioxilan API sourcing.

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FAQs

1. What are the primary criteria for selecting an API supplier for Ioxilan?
Manufacturers must ensure GMP compliance, high purity standards, consistent quality, adequate capacity, and robust regulatory standing, including certifications from agencies like FDA or EMA.

2. Are regional API suppliers sufficient to meet global demand for Ioxilan?
While regional suppliers provide flexibility, global demand may require sourcing from multiple regions with proven capacity, quality, and regulatory compliance to ensure supply continuity.

3. How does regulatory approval affect API sourcing for diagnostic agents like Ioxilan?
Regulatory approval ensures APIs meet safety, efficacy, and manufacturing standards. Suppliers lacking these approvals may face restrictions, impacting their suitability for pharmaceutical manufacturing.

4. What trends are influencing the future of API sourcing for contrast agents?
Emerging trends include localization of manufacturing, sustainable synthesis techniques, and increased use of CMOs, aiming to enhance supply security and quality.

5. Can small-scale or new manufacturers supply high-quality APIs for Ioxilan?
Yes, provided they meet stringent quality, regulatory, and capacity requirements. Emerging manufacturers often partner with established firms to gain access to validated synthetic routes and compliance standards.

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References:

[1] "Ioxilan (IOXILAN) Drug Profile." National Library of Medicine, PubChem.
[2] "Contrast Media API Manufacturing." Pharmaceutical Technology, 2022.
[3] "Global API Manufacturing Landscape," WHO, 2021.
[4] "Regulatory Requirements for Injectable APIs," EMA Guidelines, 2023.