Bulk Pharmaceutical API Sources for ISOVUE-M 300

Bulk Pharmaceutical API Sources for ISOVUE-M 300

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
Key Organics/BIONET		KS-1421

Bulk Active Pharmaceutical Ingredient (API) Sources for: ISOVUE-M 300

Last updated: August 4, 2025

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Introduction

Isovue-M 300, with the generic name iopamidol, is a non-ionic, water-soluble contrast agent predominantly used in radiology procedures such as computed tomography (CT) scans and angiography. Its efficacy depends on the high purity and quality of the active pharmaceutical ingredient (API), iopamidol. As demand surges in medical imaging, securing reliable bulk API sources becomes vital for pharmaceutical companies, contract manufacturing organizations (CMOs), and healthcare providers. This comprehensive analysis explores the key global API suppliers for iopamidol, their market positioning, quality standards, and strategic considerations for procurement.

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Overview of Iopamidol API Market

The API market for radiocontrast agents like iopamidol is characterized by a limited number of specialized manufacturers, given the rigorous regulatory requirements, complex synthesis processes, and stringent quality assurance standards. The primary producers are often integrated within larger pharmaceutical conglomerates or niche specialty chemical manufacturers with proven expertise in contrast media APIs. Key regions include Europe, North America, and Asia-Pacific, each hosting significant API manufacturing capabilities.

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Major API Suppliers for Isovue-M 300 (Iopamidol)

1. Bracco Imaging S.p.A.

   Bracco is the originator of iopamidol and the proprietary brand Isovue-M 300. The company owns extensive manufacturing facilities across Italy and maintains strict compliance with Good Manufacturing Practices (GMP). Bracco's API manufacturing is vertically integrated, ensuring control over quality, supply chain, and regulatory adherence. As the patent holder, Bracco primarily supplies its own branded APIs and formulations but also offers bulk APIs for licensed manufacturing.

2. Henkel AG & Co. KGaA

   Henkel's pharmaceutical division specializes in active ingredients for contrast media. The company produces high-purity APIs, including iopamidol, utilizing advanced synthesis routes that meet pharmacopeial standards. Henkel's global presence ensures supply stability and compliance with international regulatory frameworks, including EMA and FDA standards. Their APIs serve both branded and generic contrast agents.

3. Jiangsu Hengrui Medicine Co., Ltd. (China)

   As a leading Chinese pharmaceutical manufacturer, Jiangsu Hengrui has expanded its API portfolio to include contrast media agents such as iopamidol. The company invests heavily in quality control and GMP compliance, aiming to meet international export standards. Their strategic focus on the Asia-Pacific market and increasing approval in Western markets makes them an important regional API supplier.

4. Fujifilm Toyama Chemical Co., Ltd.

   A Japanese company with advanced chemical synthesis capabilities, Fujifilm produces high-quality APIs for imaging agents. Their manufacturing process emphasizes purity, stability, and batch-to-batch consistency. They serve both domestic Japanese and international markets with GMP-compliant APIs.

5. EgiPharm (Egypt)

   EgiPharm has developed expertise in the manufacturing of contrast media APIs, including iopamidol. The company has established a GMP-certified facility, attempting to serve global markets with competitive pricing. While less prominent than European or North American suppliers, EgiPharm is emerging as an alternative source, especially for regional distributors.

6. Yankuang Group (China)

   This industrial conglomerate has diversified into specialty chemicals, including contrast media APIs. Their API manufacturing facilities aim to meet international quality standards, and they are increasingly exporting to markets requiring cost-effective options.

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Supply Chain and Quality Considerations

Securing a reliable API source for ISOVUE-M 300 involves evaluating several factors:

• Regulatory Compliance: Suppliers must comply with GMP, ISO standards, and be certified by relevant authorities such as the FDA, EMA, or China FDA.
• Quality Control: High purity levels (typically ≥99%), batch consistency, and rigorous impurity profiling are critical. Certificates of analysis (CoA) and stability data are essential documentation.
• Regulatory Documentation: Proper registration dossiers, validation reports, and compliance with pharmacopoeial standards (e.g., USP, Ph. Eur.) facilitate seamless approval processes.
• Supply Stability: Consideration of production capacity, lead times, and contingency options is vital, especially given the critical role of contrast agents in diagnostic procedures.
• Pricing and Contracts: Competitive pricing, flexible MOQ (minimum order quantity), and long-term agreements support cost management and supply assurance.

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Emerging Trends and Strategic Implications

• Local Manufacturing Initiatives: Countries like China and India are investing in manufacturing capabilities, which could diversify supply chains and reduce dependence on Western suppliers.

• Regulatory Accelerations: As global agencies streamline approval processes, suppliers who align early with regulatory requirements may gain competitive advantages.

• Partnership and Licensing Agreements: Collaborations between originators like Bracco and generic manufacturers facilitate API licensing, increasing market access.

• Technological Innovations: Advances in synthetic chemistry may lead to more efficient, cost-effective API production methods, expanding supplier options.

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Conclusion

The procurement landscape for iopamidol API, specifically for ISOVUE-M 300, features a limited but strategically significant set of global suppliers. Established producers such as Bracco, Henkel, and Fujifilm ensure high-quality, GMP-compliant APIs tailored to regulatory standards across markets. Emerging players from China and Egypt present additional options, often with competitive pricing but varying levels of regulatory maturity.

Business professionals must weigh factors such as regulatory alignment, quality standards, supply stability, and cost when selecting an API partner. Long-term partnerships, comprehensive quality audits, and robust supply agreements can mitigate risks and support consistent production of contrast media formulations.

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Key Takeaways

• Limited but Quality-Driven Market: The iopamidol API market is concentrated among a handful of reputable manufacturers with stringent quality frameworks.
• Originator Control: Bracco remains the primary source for the proprietary ISOVUE-M 300 API, emphasizing the importance of direct partnerships or licensed manufacturing arrangements.
• Emerging Regional Suppliers: China and Egypt are becoming significant suppliers, offering competitive pricing but requiring careful quality and regulatory assessment.
• Regulatory Alignment: Compliance with GMP and pharmacopoeial standards remains non-negotiable for API sourcing, influencing approval timelines and market access.
• Strategic Sourcing: Building resilient supply chains through diversified suppliers, long-term contracts, and quality audits enhances reliability and cost efficiency.

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FAQs

1. Can I procure iopamidol API directly from the patent holder for manufacturing?
   Yes. Companies like Bracco often license their APIs to qualified manufacturers or contract production, subject to regulatory approvals and supply agreements.

2. What are the key regulatory certifications needed for iopamidol API suppliers?
   Suppliers should possess GMP certification from authorities such as the FDA, EMA, or equivalent, along with ISO certifications, and adhere to pharmacopoeial standards like USP or Ph. Eur.

3. Are there quality differences between Western and Asian manufacturers of iopamidol API?
   While high-quality standards are globally mandated, differences may exist in manufacturing practices, documentation, and regulatory track records. Due diligence and audits are recommended when sourcing from emerging markets.

4. What are the main factors influencing the price of iopamidol API?
   Factors include raw material costs, production complexity, regulatory compliance, batch size, and supplier location. Cost-effective suppliers often offer competitive pricing but must meet quality standards.

5. Is sole sourcing of iopamidol API risky?
   Yes. Dependence on a single supplier can lead to supply disruptions. Diversification and establishing multiple qualified sources are prudent strategies.

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References

[1] Bracco Imaging S.p.A., "Iopamidol API Technical Data," 2022.
[2] European Medicines Agency, "Guidelines on the manufacture of contrast media APIs," 2021.
[3] Pharmaceutical Technology, "Global Contrast Media API Market Outlook," 2022.
[4] Jiangsu Hengrui Medicine Co., Ltd., "Product Portfolio and Manufacturing Standards," 2022.
[5] FDA, "GMP Compliance for Pharmaceutical Ingredients," 2023.