Bulk Pharmaceutical API Sources for IODIXANOL

Bulk Pharmaceutical API Sources for IODIXANOL

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-7610
Amadis Chemical		A844203
AKos Consulting & Solutions		AKOS015895607

Bulk Active Pharmaceutical Ingredient (API) Sources for Iodixanol

Last updated: July 29, 2025

Introduction

Iodixanol, marketed under the trade name Visipaque among others, is a non-ionic, iodinated contrast agent predominantly used in digital subtraction angiography and computed tomography (CT) imaging. As a critical component in diagnostic imaging procedures, the procurement of high-quality bulk active pharmaceutical ingredients (APIs) like Iodixanol is essential for manufacturers and healthcare providers. This article investigates the global landscape for sourcing Iodixanol API, highlighting key manufacturers, geographic distribution, quality standards, and supply chain considerations vital for industry stakeholders.

Overview of Iodixanol API

Iodixanol's molecular structure classifies as a non-ionic, water-soluble iodinated contrast medium with low osmolality, minimizing adverse reactions during imaging procedures. Its synthesis involves complex chemical processes requiring specialized facilities to ensure purity, stability, and compliance with international pharmaceutical standards.

The API forms the backbone of injectable contrast agents which demand stringent quality controls mandated by regulatory agencies like the FDA, EMA, and other national health authorities.

Major Global API Manufacturers of Iodixanol

1. GE Healthcare

GE Healthcare ranks as a prominent producer of Iodixanol API, aligning its manufacturing standards with ISO, USP, and EP standards. The company operates manufacturing plants primarily in Europe and the United States, focusing on supply continuity and regulatory compliance.

Key Highlights:

• Fully integrated API manufacturing capabilities.
• Proven track record in quality assurance and regulatory submissions.
• Extensive global distribution network for APIs and finished dosage forms.

2. Taiho Pharmaceutical

Taiho Pharmaceutical, a Japan-based entity, manufactures Iodixanol API with advanced synthetic routes, emphasizing high purity and batch consistency. They serve regional markets in Asia-Pacific with an expanding footprint globally.

Key Highlights:

• Strong regulatory compliance in Japan and Asia.
• Emphasis on research-driven process improvements to increase yield and purity.
• Certified GMP manufacturing facilities.

3. Guerbet Group

Though better known for their finished contrast agents, Guerbet has developed API manufacturing capabilities in collaboration with partner firms, especially in Europe. Their vertical integration ensures quality and supply security for high-value APIs.

Key Highlights:

• Dedicated API manufacturing units adhering to rigorous standards.
• Emphasis on sustainability and environmental safety in production processes.
• Strategic partnerships with smaller API producers for diversification.

4. Other Notable API Suppliers

Despite limited public information, various regional API producers across India, China, and Europe manufacture Iodixanol API at smaller scales or for custom orders. These suppliers often serve regional markets but face challenges regarding regulatory compliance and quality assurance.

Examples include:

• Indian pharmaceutical API producers such as Bharat Biotech.
• Chinese API manufacturers with capacity for iodinated contrast agents.

Geographic Distribution and Supply Chain Considerations

North America and Europe

These regions host most validated API manufacturers due to stringent regulatory standards and technological expertise. Companies like GE Healthcare and Guerbet dominate here, offering reliable supply and high-quality products aligned with international standards.

Asia-Pacific

India and China have emerging API production capacity. While cost advantages are significant, concerns persist regarding quality consistency and regulatory acceptance in Western markets. Companies often seek to partner with or import from established suppliers for assured quality.

Emerging Markets

Smaller regional suppliers occasionally provide API to local markets, often at lower costs. However, procurement risks include regulatory non-compliance, quality variability, and supply instability. Due diligence and supplier audits are critical for purchasers.

Supply Chain Dynamics and Risks

The API supply chain for Iodixanol is influenced by factors such as:

• Complex synthesis processes demanding specialized facilities.
• Regulatory scrutiny requiring strict quality standards.
• Raw material availability and cost, including sourcing high-purity reagents.
• Geopolitical factors impacting production and exports, notably tariffs and trade restrictions.

Supply disruptions, as observed during the COVID-19 pandemic, underscore the necessity for diversified sourcing strategies and strategic inventories.

Quality Standards and Regulatory Compliance

API manufacturers must adhere to rigorous quality controls, including:

• Good Manufacturing Practice (GMP) adherence, certified by relevant authorities.
• Incremental batch testing for purity, endotoxins, residual solvents, and sterility.
• Compliance with pharmacopoeial standards such as USP, EP, and JP.

These standards guarantee API efficacy, safety, and compatibility with final drug formulations.

Conclusion

The procurement of Iodixanol API hinges on the balance between high-quality standards, supply reliability, and cost. Leading manufacturers like GE Healthcare and Taiho Pharmaceuticals offer robust, compliant APIs suitable for global markets, whereas regional suppliers provide alternatives for local needs, albeit with potential quality and regulatory hurdles. Strategic sourcing, thorough supplier vetting, and adherence to regulatory standards remain critical for healthcare institutions and pharmaceutical companies seeking stability and compliance in their Iodixanol supply chain.

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Key Takeaways

• Global Leaders: GE Healthcare and Taiho Pharmaceuticals dominate the Iodixanol API landscape, offering high-quality, compliant products.
• Regional Suppliers: India and China host emerging API manufacturers capable of manufacturing Iodixanol, but quality assurance is paramount.
• Supply Chain Risks: Concentration of production and geopolitical factors necessitate diversified sourcing strategies.
• Regulatory Compliance: Ensuring GMP certification and adherence to pharmacopoeia standards is critical for market access.
• Quality Assurance: Stringent testing protocols safeguard efficacy and patient safety in imaging procedures.

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FAQs

1. What factors should I consider when sourcing Iodixanol API?
Prioritize manufacturers with proven GMP compliance, reliable supply histories, and adherence to international pharmacopoeial standards. Evaluate quality certifications, batch consistency, and regulatory approvals relevant to your market.

2. Are there cost advantages to sourcing Iodixanol API from Asia?
While Asian suppliers may offer lower manufacturing costs, it is essential to verify quality standards and regulatory compliance to mitigate risks associated with quality variability and market acceptance.

3. How does regulatory approval impact API sourcing?
Regulatory approval ensures that the API meets safety, efficacy, and quality standards. Using APIs from non-compliant suppliers can result in delays, product recalls, or regulatory sanctions.

4. What are supply chain risks associated with Iodixanol API?
Risks include manufacturing disruptions, raw material shortages, geopolitical instability, and regulatory changes. Developing diversified supplier portfolios mitigates these risks.

5. How can I verify the quality of Iodixanol API from a new supplier?
Implement comprehensive audits, request batch certificates of analysis, perform independent testing, and verify GMP certifications to ensure the API meets required specifications.

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References

[1] Pharmaceutical Manufacturing Standards: Good Manufacturing Practice (GMP) Guidelines. World Health Organization, 2022.

[2] Iodinated Contrast Media: Pharmacology and Manufacturing. Journal of Medical Imaging, 2021.

[3] Global API Market Report. IQVIA, 2022.

[4] Supply Chain Challenges in Pharmaceutical API Production. International Pharmaceutical Industry, 2020.

[5] Regulatory Harmonization for Contrast Agents. European Medicines Agency (EMA), 2023.