Bulk Pharmaceutical API Sources for IOPAMIDOL-300

Bulk Pharmaceutical API Sources for IOPAMIDOL-300

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		65492
MolPort		MolPort-003-848-224
ISpharm		I01-8407
ABI Chem		AC1L23CM
ABI Chem		AC1Q4PBP
ChemMol		49424537
Amadis Chemical		A834067

Bulk Active Pharmaceutical Ingredient (API) Sources for Iopamidol-300: A Comprehensive Industry Overview

Last updated: July 28, 2025

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Introduction

Iopamidol-300, a non-ionic iodine-based contrast agent, plays a critical role in diagnostic radiology, particularly in computed tomography (CT) imaging. Its bulk API sourcing forms the backbone of global supply chains, influencing clinical availability, cost, and regulatory compliance. As the demand for high-quality contrast media escalates, understanding the landscape of API manufacturing sources for Iopamidol-300 becomes vital for pharmaceutical companies, healthcare providers, and supply chain managers.

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Manufacturing Overview of Iopamidol-300 API

Iopamidol-300 is synthesized through intricate chemical processes involving multistep organic reactions, purification, and strict quality control. The API’s complexity, including the iodine-rich structure and specific stereochemistry, necessitates high manufacturing standards, typically aligned with Good Manufacturing Practices (GMP).

The production landscape features both major pharmaceutical manufacturers and regional API producers. These sources differ in terms of volume capacity, compliance, and technology, which impacts global supply chain resilience.

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Key API Manufacturing Countries and Leading Suppliers

1. United States

The U.S. hosts several leading API manufacturers, known for adherence to stringent regulatory standards enforced by the FDA. Major players include:

• GE HealthCare (formerly part of GE Healthcare)
• BASF Healthcare Solutions
• Alkeus Pharmaceuticals

While some of these companies focus primarily on finished drug products, they maintain in-house or contracted API manufacturing capabilities. For instance, GE Healthcare, beyond its imaging systems, has engaged in API sourcing strategies to ensure consistent supply.

2. Europe

European manufacturers are prominent, leveraging advanced chemical synthesis and purification technologies:

• Fresenius Kabi (Germany): Known for high-quality APIs, including contrast agents.
• Bracco Imaging (Italy): Noted for integrating API production within its broader pharmaceutical operations.

European suppliers often supply both domestically and internationally, benefitting from rigorous GMP standards and regulatory compliance frameworks.

3. China

China's pharmaceutical sector has rapidly expanded, offering large-scale API manufacturing at competitive prices:

• Shanghai Haoyuan Chemexpress Co. Ltd
• Jiangsu Hengrui Medicine Co. Ltd
• Zhejiang Medicine Co.

Chinese producers are significant in the global API supply chain for iodine-based contrast media. They often provide both bulk APIs and intermediates, supported by extensive government incentives and growing R&D investments.

4. India

India is a notable hub for generic API manufacturing, including iodine derivatives:

• Divi's Laboratories
• Aurobindo Pharma
• Biocon

These firms have invested in compliant production facilities, often exporting APIs globally, including Iopamidol-300, to meet increasing demand for affordable imaging agents.

5. Other Regions

Manufacturers in Japan, South Korea, and Israel also contribute to the supply ecosystem, emphasizing technological innovation and high regulatory standards. Companies like FUJIFILM and Samsung Biologics play roles in advanced API manufacturing, though their focus varies.

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Sourcing Challenges and Industry Trends

Regulatory Compliance

API manufacturers must navigate complex regulatory landscapes, especially given the iodine content and potential toxicity. Certificates of GMP compliance, DMF (Drug Master Files), and regulatory approvals such as FDA and EMA filings influence supplier viability.

Supply Chain Disruptions

Global disruptions—stemming from geopolitical tensions, pandemic-related logistical issues, or raw material shortages—have impacted API availability. Dependence on a limited number of regional sources, especially in China and India, heightens vulnerability.

Technological Innovation and Quality Assurance

Manufacturers employing advanced purification methods, such as chromatography and high-performance liquid chromatography (HPLC), ensure product purity and consistency. Continuous process improvements address concerns related to heavy metal impurities and residual solvents.

Sustainability and Regulatory Pressures

Environmental regulations increasingly mandate sustainable manufacturing practices, prompting API producers to adopt greener technologies, reducing waste, and minimizing toxic emissions.

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Key Considerations for API Procurement

• Quality and Compliance: Verify GMP certification, quality assurance protocols, and regulatory approvals.
• Supply Reliability: Establish relationships with multiple suppliers across regions to mitigate risks.
• Pricing Dynamics: Balance cost considerations with quality assurance, especially amid fluctuating raw material costs.
• Intellectual Property and Regulatory Filings: Confirm supplier capabilities to meet regulatory documentation requirements suitable for different markets.

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Future Outlook

The API supply chain for Iopamidol-300 is poised for ongoing evolution driven by technological advances, regulatory standards, and geopolitical factors. The increasing demand for diagnostic imaging and expanding healthcare infrastructure globally suggest sustained growth. Diversification of sourcing strategies and investment into regional manufacturing capacities will be critical to ensure supply stability.

Emerging production technologies, such as continuous-flow synthesis and biotechnological methods, could further refine API manufacturing, offering potential enhancements in purity, cost-efficiency, and environmental sustainability.

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Key Takeaways

• The global API landscape for Iopamidol-300 is diverse, with significant manufacturing presence in the U.S., Europe, China, and India.
• Ensuring high-quality, GMP-compliant sources remains paramount for regulatory approval and patient safety.
• Supply chain resilience requires diversifying suppliers and geographically spreading procurement.
• Technological advancements and regulatory pressures favor manufacturers adopting greener, more efficient synthesis processes.
• Strategic partnerships with reputable API producers are essential for pharmaceutical companies aiming to secure a stable supply of Iopamidol-300.

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FAQs

1. What are the primary regions manufacturing Iopamidol-300 API?
Major manufacturing regions include North America (U.S.), Europe (Germany, Italy), China, and India, each with prominent API producers equipped to supply high-quality iodine contrast agents.

2. How does geographic sourcing impact API supply stability for Iopamidol-300?
Geographic sourcing influences supply stability based on regional manufacturing capacity, regulatory environment, and geopolitical factors. Diversification reduces risks of disruptions caused by regional issues.

3. What quality assurance measures should buyers verify before sourcing Iopamidol-300 API?
Buyers should verify GMP certification, DMF filings, impurity profiles, and adherence to regional regulatory standards such as FDA and EMA.

4. Are there technological innovations shaping Iopamidol-300 API manufacturing?
Yes. Continuous-flow synthesis, greener purification techniques, and automation are enhancing purity, reducing costs, and minimizing environmental impact.

5. What future trends should stakeholders monitor regarding API sourcing for contrast agents?
Stakeholders should watch advancements in sustainable manufacturing, regional capacity expansion, diversified supply chains, and regulatory adaptations influencing API availability.

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References

[1] U.S. Food and Drug Administration (FDA). Drug Master Files.
[2] European Medicines Agency (EMA). Guidelines on API manufacturing standards.
[3] Industry reports from IQVIA and PharmaIQ on contrast media manufacturing.
[4] Company disclosures and public filings of major API-producing firms.
[5] Market analysis reports from IQVIA, EvaluatePharma, and GlobalData.

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Note: The landscape continues to evolve; stakeholders should maintain ongoing engagement with suppliers and regulatory updates for optimal sourcing strategies.