Bulk Pharmaceutical API Sources for ISOVUE-200

Bulk Pharmaceutical API Sources for ISOVUE-200

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-848-224
Amadis Chemical		A834067
AKos Consulting & Solutions		AKOS015891034
AbaChemScene		CS-2917
MedChemexpress MCE		HY-B0684

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

Last updated: July 28, 2025

Introduction

Isovue-200, internationally recognized as iopamidol, is a widely used contrast agent in diagnostic imaging, particularly for computed tomography (CT) scans. As an injectable radiographic contrast medium, the active pharmaceutical ingredient (API)—iopamidol—is crucial for ensuring efficacy, safety, and quality in formulation. Securing reliable bulk API sources is vital for pharmaceutical manufacturers aiming to maintain supply chain integrity, comply with regulatory standards, and meet global demand.

This report delineates key API sourcing options for iopamidol (ISOVUE-200), analyzing global manufacturers, importers, and suppliers specializing in this high-value pharmaceutical raw material. It emphasizes criteria such as regulatory compliance, quality assurance, manufacturing capacity, and sourcing reliability, providing a strategic guide for stakeholders in procurement and manufacturing.

Overview of Iopamidol (ISOVUE-200 API)

Iopamidol is a non-ionic, water-soluble, iodine-based contrast medium used in X-ray imaging. Its molecular structure involves a tri-iodinated benzene ring linked via amide groups to a substituted propanolamine backbone, conferring high radiopacity.

The production of iopamidol APIs necessitates complex synthetic routes, rigorous purification processes, and compliance with Good Manufacturing Practices (GMP). Leading producers supply bulk API primarily to certified pharmaceutical entities worldwide.

Global API Manufacturers for Iopamidol

1. Bracco Imaging S.p.A.

• Overview: Bracco, headquartered in Italy, is a recognized leader in contrast media manufacturing, with extensive experience supplying both APIs and finished formulations.
• API Capabilities: Bracco produces high-purity iopamidol API at GMP-compliant facilities.
• Regulatory Status: APIs sourced from Bracco are often pre-approved or approved by major regulatory bodies like the FDA, EMA, and others.
• Supply Chain: Bracco maintains a robust global distribution network, ensuring supply stability.

2. Guerbet Group

• Overview: Headquartered in France, Guerbet specializes in contrast agents, imaging, and interventional radiology products.
• API Capability: Guerbet manufactures and supplies iopamidol bulk API through its in-house facilities, emphasizing product quality and compliance.
• Strategic Positioning: The company is actively expanding its API manufacturing capacity, aligning with increasing global demand.

3. Liebel-Flarsheim (Now part of Medtronic)

• Note: While primarily focused on medical device manufacturing, Liebel-Flarsheim historically collaborated in contrast media formulations; API supply may involve external contractors or licensing agreements.

4. China-based API Manufacturers

• Overview: Numerous Chinese pharmaceutical API producers have established capabilities for radiocontrast agents, often at competitive prices.
• Key Players:
  • North China Pharmaceutical Group (NCPC): Offers high-quality APIs with GMP certification.
  • Jiangsu Hengrui Medicine Co., Ltd.: Known for complex synthetic APIs, including iodine compounds.
• Regulatory Challenges: Import and approval processes into regulated markets may be lengthier; compliance with cGMP and international standards is critical.

5. Indian Pharmaceutical API Suppliers

• Overview: India’s API manufacturing sector is robust, with several firms engaged in synthesizing iodine-based contrast agents.
• Key Players:
  • Biochem Pharmaceutical Industries Ltd
  • Shilpa Medicare Ltd
  • Aurigene Discovery Technologies
• Market Position: These firms often export to multinational companies under strict regulatory oversight and possess requisite certifications.

6. Contract Manufacturing and Sourcing Platforms

• Several Contract Development and Manufacturing Organizations (CDMOs) facilitate bulk API sourcing for pharmaceutical companies, including those specialized in iodine radiocontrast agents.

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Key Criteria for Selecting API Suppliers

Regulatory Compliance

Manufacturers must ensure APIs are produced in facilities holding GMP certifications aligned with regional regulatory agencies (FDA, EMA, PMDA). The API must meet pharmacopeial standards such as USP, EP, or JP.

Quality Assurance

Analytical data verifying purity (>99%), absence of residual solvents, endotoxins, and heavy metals are essential. Certificates of Analysis (CoA), stability data, and batch consistency bolster confidence in supply quality.

Manufacturing Capacity and Reliability

Suppliers should demonstrate sufficient production capacity to meet demand fluctuations. Long-term supply agreements mitigate risks of shortages.

Pricing and Supply Terms

Competitive pricing, flexible MOQ (Minimum Order Quantities), lead times, and logistics support are vital factors influencing procurement decisions.

Regulatory & Export Licenses

Suppliers must possess necessary export licenses, Good Distribution Practices (GDP) certifications, and compliance with international trade regulations.

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Emerging Trends and Considerations

Global Supply Chain Diversification

Given geopolitical uncertainties and the COVID-19 pandemic’s impact, diversifying API sources ensures supply resilience. Relying solely on a single supplier or region exposes manufacturers to substantial risks.

Quality Standard Harmonization

Increasing international regulatory harmonization underscores the importance of sourcing from suppliers compliant with global standards, reducing approval hurdles in key markets.

Technological Advances

Innovations in synthetic methodologies and purification techniques are enhancing the quality and purity of iopamidol APIs, influencing sourcing choices towards technologically advanced manufacturers.

Environmental and Sustainability Factors

Manufacturers prioritizing environmentally sustainable processes and waste management are increasingly favored, aligning with global ESG (Environmental, Social, Governance) standards.

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Conclusion

Securing a reliable bulk API source for ISOVUE-200 (iopamidol) warrants diligent evaluation of manufacturer certifications, production capacities, and regulatory compliance. Established suppliers such as Bracco and Guerbet dominate the high-quality API supply landscape, supported by their international regulatory acceptance. Chinese and Indian API producers offer cost-effective alternatives, but often require meticulous qualification and validation processes.

A diversified supply chain model, emphasizing quality, compliance, and strategic partnership, is essential for safeguarding continuity in the production of iopamidol-based contrast media. As demand surges in diagnostic imaging, transparent engagement with reputable API manufacturers mitigates risk and fosters sustained operational success.

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Key Takeaways

• Global leaders like Bracco and Guerbet dominate the high-quality API supply market for iopamidol, supported by stringent regulatory compliance.
• Diversification of suppliers, including Chinese and Indian manufacturers, can optimize costs but necessitates thorough qualification processes.
• Regulatory alignment and GMP compliance are non-negotiable criteria for API sourcing, impacting approval timelines and market access.
• Supply chain resilience hinges on capacity verification, long-term agreements, and proactive monitoring of geopolitical and logistical factors.
• Innovation and sustainability are increasingly influencing API manufacturing, with suppliers adopting advanced, eco-friendly processes.

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FAQs

1. What are the primary considerations when sourcing iopamidol API?
Ensuring GMP compliance, high purity standards (>99%), regulatory approval status, reliable manufacturing capacity, and robust quality assurance processes are essential to ensure safety, efficacy, and supply continuity.

2. Are there regional restrictions on importing iopamidol API?
Yes, import regulations vary; each country may require specific licenses, certifications, and adherence to local pharmacopeial standards. Regulatory due diligence is critical before procurement.

3. Can domestic API manufacturing replace international suppliers?
While domestic production may reduce logistical complexities, the quality and regulatory approval status of domestic APIs must match international standards to ensure consistent therapeutic outcomes and compliance.

4. How does geopolitical instability impact API sourcing?
Geopolitical factors can disrupt supply chains due to trade restrictions, licensing issues, or export bans. Diversifying suppliers and regions mitigates such risks.

5. What emerging trends could influence future API sourcing for contrast agents?
Advances in synthetic chemistry, sustainability-focused manufacturing, and stricter regulatory standards will influence supplier selection, emphasizing innovation, environmental responsibility, and compliance.

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References

1. United States Pharmacopeia. USP Monograph for Iopamidol.
2. European Pharmacopoeia. Monograph on Iopamidol.
3. Bracco Group official website and product dossier.
4. Guerbet Group corporate information.
5. Industry reports on iodine contrast media manufacturing trends.