Bulk Pharmaceutical API Sources for ISOVUE-M 200

Bulk Pharmaceutical API Sources for ISOVUE-M 200

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-848-224
Amadis Chemical		A834067
AKos Consulting & Solutions		AKOS015891034

Bulk Active Pharmaceutical Ingredient (API) Sources for ISOVUE-M 200

Last updated: August 9, 2025

Introduction

Isovue-M 200 (iohexol) is a non-ionic, water-soluble contrast agent widely used in radiographic imaging to enhance visualization of blood vessels, organs, and tissues. Its pharmaceutical formulation hinges on the quality and consistency of its active pharmaceutical ingredient (API), iohexol. As healthcare demands grow and regulatory standards tighten, sourcing high-grade API reliably and compliantly becomes vital for pharmaceutical manufacturers. This article explores the landscape of bulk API suppliers for Iohexol 200 mg/mL, emphasizing the importance of quality, regulatory compliance, and strategic sourcing.

Understanding Iohexol API

Iohexol is a non-ionic, low-osmolar, iodine-containing contrast agent synthesized through a multi-step chemical process. Its efficacy and safety profile depend significantly on the purity and stability of the API. The API must meet stringent pharmacopeial standards, such as those outlined in the European Pharmacopoeia, United States Pharmacopeia (USP), or other regional standards.

Global API Manufacturers of Iohexol

1. GE Healthcare (Danaher Corporation)

• Overview: GE Healthcare is notable as both a manufacturer of the finished contrast agents and the API, iohexol. Their vertically integrated production ensures control over quality, supply chain stability, and regulatory adherence.
• API Sourcing: GE Healthcare produces bulk iohexol API, often supplied directly to their own manufacturing facilities for respective finished product formulations.
• Strengths: Proven track record, comprehensive quality standards, global distribution, and strong regulatory compliance (FDA, EMA, etc.).
• Considerations: Limited independent sourcing options; primarily offers API for internal or close partner use.

2. Eumedica (Part of the Henkel Group)

• Overview: Eumedica specializes in producing high-purity iodine-based contrast media, including iohexol, and offers API supplies for licensed manufacturers.
• API Sourcing: Eumedica supplies bulk iohexol API predominantly to European and certain international markets.
• Strengths: Consistent quality, adherence to strict European standards, and flexible supply arrangements.
• Considerations: Market reach might be more regional, with some capacity constraints depending on demand.

3. Tianjin Biochem Pharmaceutical (China)

• Overview: A significant Chinese API manufacturer, Tianjin Biochem has developed a portfolio of contrast agents and their APIs.
• API Sourcing: Offers bulk iohexol API to both domestic and international markets, with increasing acceptance owing to competitive pricing.
• Strengths: Cost advantages, expanding manufacturing capacity, regulatory compliance for certain markets.
• Considerations: Variability in regulatory acceptance across regions; thorough due diligence required for quality assurance.

4. Wuhan Yaxin Biology & Pharmaceutical Co., Ltd.

• Overview: Another Chinese API producer with capacity for high-purity iodine contrast agents.
• API Sourcing: Supplies to regional markets, with efforts to expand global distribution.
• Strengths: Competitive pricing, growing quality certifications.
• Considerations: As with other Chinese suppliers, compliance with international regulatory requirements must be verified.

5. Other Notable Asian API Suppliers

• Wuhan Huijian Pharmaceutical Co.
• Shanghai Baoshan Pharmaceutical Co.

These companies are increasingly involved in the production of iohexol API, primarily serving the domestic Chinese market, with selective export channels.

Key Considerations When Sourcing Iohexol API

Quality and Regulatory Compliance

Ensuring API quality aligns with pharmacopeia standards (USP, EP, JP) is crucial. All suppliers should maintain certificates of analysis, stability data, and Good Manufacturing Practice (GMP) compliance. Suppliers with existing regulatory approvals in target markets facilitate smoother registration and compliance processes.

Supply Chain Reliability

A consistent supply chain prevents manufacturing disruptions. Strategic partnerships with established suppliers like GE Healthcare or Eumedica offer reliability. When sourcing from emerging markets, thorough due diligence on manufacturing capacity, export regulations, and quality management systems is essential.

Cost and Economic Considerations

While Chinese and Indian API manufacturers often offer competitive pricing, the total cost must consider regulatory compliance, quality assurance, and potential logistics or import tariffs.

Intellectual Property and Licensing

Indentify licensing arrangements, if any, associated with the API. Some manufacturers may produce iohexol API under licensed technology, which could impact procurement options.

Regulatory Challenges and Opportunities

Manufacturers and API suppliers must ensure adherence to regional Good Manufacturing Practice (GMP) standards. For API sourced from China and India, securing regulatory approvals (e.g., FDA, EMA) can be complex but manageable with robust quality documentation. Regulatory acceptance remains a critical factor influencing supply chain decisions.

Emerging Trends in API Sourcing

• Localized Manufacturing Initiatives: Increasing efforts by regions to develop domestic API production, reducing dependence on imports.
• Enhanced Quality Certifications: Suppliers are investing in ISO, GMP, and other quality standards to meet global demands.
• Digital Supply Chain Transparency: Use of blockchain and digital platforms to verify API authenticity and traceability.

Conclusion

Sourcing high-quality iohexol API for ISOVUE-M 200 demands a strategic approach rooted in regulatory compliance, quality assurance, and supply reliability. Established global manufacturers like GE Healthcare and Eumedica remain primary sources, offering robust quality systems aligned with international standards. Chinese API producers are expanding their capabilities, presenting cost-effective options with a caveat for due diligence on quality and regulatory validation. Pharmaceutical companies must weigh these factors carefully to ensure uninterrupted supply and compliance, ultimately supporting the safety and efficacy of their contrast agent formulations.

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Key Takeaways

• Leading API suppliers for iohexol include GE Healthcare, Eumedica, and Chinese manufacturers with expanding capacity.
• Regulatory compliance and quality assurance are critical in API selection, influencing approval timelines and market acceptance.
• Chinese and Indian API producers offer cost advantages, but thorough evaluation of quality certifications is necessary.
• Building strategic partnerships with established manufacturers enhances supply chain resilience.
• Ongoing advancements in supply chain transparency and localized manufacturing are shaping future API sourcing strategies.

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FAQs

1. What factors should pharmaceutical companies consider when selecting an Iohexol API supplier?
Quality standards, regulatory compliance, supply chain reliability, cost, and the supplier’s track record in manufacturing GMP-grade API are essential. Compatibility with regional regulatory requirements also influences supplier selection.

2. Are Chinese API manufacturers suitable for global Iohexol supply?
Yes, many Chinese producers meet international quality standards and have gained regulatory approvals. However, due diligence is vital to verify certifications, quality systems, and compliance with target markets’ regulations.

3. How does regulatory compliance impact API sourcing decisions?
Regulatory compliance ensures the API meets regional pharmacopoeial standards, facilitating quicker market approval and minimizing manufacturing risks. Non-compliant API can delay product registration and introduce legal liabilities.

4. What role do emerging markets play in Iohexol API supply?
Emerging markets, particularly in Asia, are expanding their API manufacturing capacity, offering cost-effective and scalable alternatives. Strategic partnerships with these suppliers can diversify supply chains but require rigorous quality verification.

5. Is API quality control essential for contrast agent safety?
Absolutely. The purity and stability of iohexol API directly impact the safety and efficacy of the final contrast agent. Stringent quality control and compliance with pharmacopeial standards are non-negotiable.

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References:

1. European Pharmacopoeia (EP). Iohexol Monograph.
2. United States Pharmacopeia (USP). Iohexol Monograph.
3. GE Healthcare. Contrast Media API Portfolio.
4. Eumedica. API Production and Supply Chain Information.
5. Global API Market Analysis Reports.