Bulk Pharmaceutical API Sources for ISOVUE-370

Bulk Pharmaceutical API Sources for ISOVUE-370

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-370

Last updated: August 1, 2025

Introduction

Isovue-370, a trade name for iopamidol solution, is a widely used iodinated contrast agent in diagnostic radiology, especially in computed tomography (CT) imaging. Its efficacy relies heavily on the quality, purity, and supply chain stability of the active pharmaceutical ingredient (API), iopamidol. As demand for high-quality contrast agents rises driven by expanding diagnostic imaging worldwide, understanding the sourcing landscape of iopamidol API becomes crucial for pharmaceutical companies, distributors, and healthcare providers seeking reliable supply chains, cost efficiencies, and regulatory compliance.

This comprehensive analysis delineates the primary bulk API suppliers for iopamidol, evaluates their capabilities, quality assurances, geographic distributions, regulatory standings, and strategic considerations. Businesses evaluating procurement pathways will find this resource essential for making informed decisions regarding their supply chain management for Isovue-370.

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Overview of Iopamidol API

Iopamidol is a non-ionic, water-soluble iodinated contrast agent with high tolerance and favorable safety profile, primarily used for imaging. Its synthesis involves complex manufacturing processes that demand stringent quality controls given the application’s medical nature. The global API market for iopamidol is concentrated among a limited number of suppliers capable of meeting Good Manufacturing Practice (GMP) standards.

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Major Bulk API Suppliers for Iopamidol

1. Bracco Imaging S.p.A.

• Location: Italy

• Capabilities: Bracco is a leading producer of iodinated contrast agents, including the manufacture of iopamidol API at scale. It has a well-established supply chain and a strong reputation for high-quality GMP-compliant production.

• Regulatory Standing: Holds multiple EMA and FDA approvals for its formulations, with API manufacturing facilities accredited according to international standards.

• Market Position: As the originator of Iopamidol, Bracco's API is widely used in proprietary formulations, ensuring high compatibility and quality assurance.

• Supply Reliability: Known for consistent supply with strategic production hubs in Europe, facilitating global distribution.

2. Jiangsu Hengrui Medicine Co., Ltd.

• Location: Jiangsu Province, China

• Capabilities: Hengrui has expanded into the production of iodinated contrast agent APIs, including iopamidol, leveraging advanced synthesis technologies and robust quality systems.

• Regulatory Status: The company has obtained GMP certification and is actively pursuing international registrations, including efforts to meet US FDA and European standards.

• Market Position: Increasingly prominent in the API production space for contrast media, driven by competitive manufacturing costs and large-scale facilities.

• Supply Reliability: Growing reputation for reliable bulk supply, though regional regulatory approvals can influence export flexibility.

3. Incepta Pharmaceuticals Ltd.

• Location: Bangladesh

• Capabilities: Incepta manufactures various APIs, including iodinated contrast agents. They have invested significantly in GMP-certified facilities to meet international demand.

• Regulatory Standing: They possess local regulatory approvals, with ongoing efforts to expand to global markets.

• Market Position: Known for cost-effectiveness and flexible production scales but may face limitations in accessing strict regulatory markets without further approval.

• Supply Reliability: Responds to regional demands effectively; potential for strategic partnerships for export expansion.

4. Alibaba and Contract Manufacturing Organizations (CMOs)

• Location: Global, primarily China and India

• Capabilities: Several CMOs in China and India offer OEM API manufacturing services, including iopamidol, often supplying smaller batches or private-label products.

• Regulatory Status: Variable; buyers must verify GMP compliance, regulatory approvals, and quality certifications.

• Market Position: Cost-effective options for bulk procurement, ideal for companies with established regulatory pathways and quality controls.

• Supply Reliability: Variable; dependent on CMO capacities, regional geopolitical factors, and quality management.

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Emerging and Niche API Suppliers

In addition to primary manufacturers, several smaller or emerging firms offer iopamidol API, often catering to niche markets or specializing in custom synthesis. These include entities in India, South Korea, and Southeast Asia. While cost advantages are apparent, due diligence regarding regulatory compliance and quality assurance is essential.

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Regulatory and Quality Considerations

Sourcing API for injectable contrast agents demands strict compliance with international standards. Suppliers with GMP certification, validated manufacturing processes, and transparent quality documentation pose less risk for regulatory scrutiny and product recalls. Hospitals and pharmaceutical firms should prioritize suppliers with proven regulatory track records and robust traceability.

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Strategic Sourcing Considerations

• Quality Assurance: Ensure API suppliers provide comprehensive Certificates of Analysis (CoA), stability data, and regulatory documentation.

• Regulatory Acceptance: Confirm suppliers hold GMP certifications recognized by relevant authorities such as the FDA, EMA, or local equivalents.

• Capacity and Reliability: Evaluate manufacturing capacity, historical supply stability, and contingency plans.

• Cost and Lead Times: Balance cost efficiencies with timely delivery, considering geopolitical factors and pandemic-related disruptions.

• Partnerships and Alliances: Establish long-term relationships to optimize supply security and facilitate regulatory approvals.

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Conclusion

The sourcing landscape for bulk iopamidol API comprises established international manufacturers and emerging regional producers. Bracco remains the industry leader with extensive regulatory and quality assurances, especially for companies seeking high reliability aligned with global standards. Chinese companies like Jiangsu Hengrui offer competitive alternatives with growing regulatory acceptance, while Asian CMOs provide flexible, cost-effective options contingent on thorough due diligence.

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Key Takeaways

• Quality and Regulatory Compliance Are Paramount: Prioritize suppliers with GMP certification and proven regulatory track records in target markets.

• Diversify Supply Sources: Reduce dependency risks by engaging multiple reputable suppliers across regions.

• Monitor geopolitical and logistical factors: Supply chains for APIs are susceptible to regional disruptions; proactive contingency planning is essential.

• Engage in Strategic Partnerships: Long-term collaborations with established suppliers can ensure continuous supply, favorable pricing, and facilitated regulatory pathways.

• Stay Informed on Market Dynamics: Keep abreast of regulatory changes, capacity expansions, and new entrants to optimize procurement strategies.

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FAQs

1. Are there alternatives to iopamidol API for contrast imaging?
Yes. Alternative iodinated contrast agents like iohexol, ioversol, and meglumine iothalamate exist, each with different pharmacokinetics and safety profiles. However, switching APIs requires extensive regulatory approval and clinical validation.

2. What are the key factors influencing the cost of iopamidol API?
Raw material costs, manufacturing complexity, regulatory compliance expenses, regional labor and energy costs, and supply chain logistics primarily influence API pricing.

3. How do regulatory approvals impact API sourcing decisions?
Regulatory approvals ensure product safety and efficacy; suppliers with recognized GMP certifications streamline registration processes and reduce market entry barriers.

4. Can smaller or emerging API manufacturers reliably supply iopamidol?
Potentially, but due diligence is critical. Assess their GMP compliance, quality control systems, and regulatory track records before engagement.

5. How is the supply chain for iopamidol API expected to evolve?
Expect increased diversification with regional manufacturing hubs, higher adoption of quality standards, and potential supply chain resilience improvements driven by regulatory tightening and technological innovations.

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References

[1] European Medicines Agency. Iopamidol Summary of Product Characteristics.
[2] Alibaba and Chinese API manufacturer profiles.
[3] Bracco Group official website and product documentation.
[4] Jiangsu Hengrui Medicine Co., Ltd. corporate disclosures and GMP certification records.
[5] Industry reports on contrast agent API market dynamics, 2022-2023.