Bulk Pharmaceutical API Sources for AMIPAQUE

Bulk Pharmaceutical API Sources for AMIPAQUE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-000-698-998
AKos Consulting & Solutions		AKOS015965061
Finetech Industry Limited		FT-0628934

Last updated: July 29, 2025

lk Active Pharmaceutical Ingredient (API) Sources for AMIPAQUE

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Introduction

Amipaque, the trade name for the contrast agent iodixanol, is a non-ionic, iso-osmolar radiographic contrast medium used in diagnostic imaging procedures such as angiography, computed tomography (CT), and other radiodiagnostic applications. As a critical injectable drug, its safety, efficacy, and supply chain integrity hinge heavily on reliable sourcing of the active pharmaceutical ingredient (API). Ensuring quality API supply chains involves identifying reputable manufacturers, understanding regulatory compliance, and navigating market dynamics.

This comprehensive review examines key API sources for iodixanol (Amipaque), highlighting major manufacturing regions, key players, and considerations for procurement and quality assurance in the global pharmaceutical landscape.

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Global API Manufacturers for Iodixanol

1. Origin and Manufacturing Regions

The primary API manufacturing regions for iodixanol include Europe, Asia—particularly India and China—and the United States. Historically, the European pharmaceutical industry has maintained stringent quality standards, facilitating production for global markets through established, GMP-compliant facilities. Asian manufacturers have expanded rapidly, leveraging cost advantages and large-scale facilities to meet global demand. The U.S. remains a hub for innovative pharmaceutical development, though fewer producers manufacture bulk iodixanol directly in the country.

2. Notable API Manufacturers

a. GE Healthcare (Now part of Danaher Corporation) / Bracco Imaging

While primarily known for branding, these companies historically controlled significant portions of the API manufacturing and supply chain for iodixanol, often outsourcing production to specialized API manufacturers or performing in-house synthesis. Danaher’s global footprint and adherence to high quality standards position it as a potential API source through partnerships.

b. Indian Manufacturers

India hosts several GMP-compliant API manufacturers capable of producing iodixanol at scale. Prominent companies include:

• Hetero Labs Ltd.
• Sun Pharmaceuticals
• Biological E. Limited
• Bharat Biotech

These firms have the capacity for large-scale synthesis of iodine-based contrast media APIs, compliant with regulatory standards such as WHO GMP, US FDA, and EMA.

c. Chinese API Suppliers

China possesses numerous API manufacturers specializing in radiopaque contrast agents’ synthesis, including:

• Shandong Xinhua Medical Equipment Co., Ltd.
• Zhejiang Guoguang Medical Device Co., Ltd.
• Harbin Pharmaceutical Group Bio-Pharmaceutical Co., Ltd.

Their manufacturing capabilities have expanded significantly, often offering competitive pricing and flexible supply agreements.

d. European API Producers

Though fewer in number, European companies such as Fresenius Kabi and specialized contract manufacturing organizations (CMOs) supply iodixanol API to global markets, emphasizing quality assurance and regulatory compliance.

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Supply Chain Dynamics and Quality Considerations

Regulatory Compliance:
API manufacturers must adhere to GMP (Good Manufacturing Practice) standards enforced by agencies such as the FDA, EMA, and WHO. For iodixanol, API suppliers should provide detailed Certificates of Analysis (CoA), demonstrating purity (>99%), stability, and absence of contaminants.

Quality Assurance:
High-purity API is critical to prevent adverse reactions. Suppliers must employ rigorous quality control measures, including chromatography and spectrometry testing. Traceability from raw materials to finished API is mandatory for regulatory audits.

Supply Chain Risks:
Reliance on a limited supplier base or geopolitical disruptions can impact API availability. Supply chain diversification, long-term contracts, and maintaining partnerships with established manufacturers mitigate these risks.

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Emerging Trends and Future Outlook

1. Increased Production in Asia:
Market expansion and cost efficiency continue to favor Asian API suppliers. Indian and Chinese manufacturers are investing in advanced synthesis technologies, increasing API quality and manufacturing capacity.

2. Contract Manufacturing and Third-Party Suppliers:
Global pharmaceutical companies increasingly utilize CMOs for API production, ensuring scalability and compliance while focusing R&D on clinical applications.

3. Regulatory Harmonization:
Consistent standards and mutual recognition agreements streamline manufacturer compliance and facilitate international sourcing, benefitting buyers seeking reliable API sources.

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Conclusion

Secure sourcing of iodixanol API hinges on understanding regional manufacturing strengths, regulatory compliance, and quality assurance practices. Indian and Chinese manufacturers dominate the landscape with rapidly expanding capacities—yet European and U.S. suppliers tend to focus on high-quality, GMP-compliant APIs for premium markets. Pharmaceutical companies and distributors must conduct thorough vendor qualification, enforce stringent quality checks, and maintain supply chain flexibility to ensure reliable availability of high-purity API for Amipaque production.

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Key Takeaways

• The primary API sources for Amipaque (iodixanol) include manufacturers in India, China, Europe, and North America.
• Indian and Chinese companies dominate due to cost and scale advantages, but European and U.S. suppliers focus on high-quality, GMP-compliant APIs.
• Regulatory compliance, thorough quality control, and supply chain resilience are critical factors in sourcing API for radiology contrast agents.
• Asian API manufacturers are expanding their capacities and technological capabilities, increasing their share in the global iodixanol API market.
• Engaging with reputable, certified API producers mitigates risks associated with contamination, subpar quality, or supply disruptions.

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FAQs

Q1: How can buyers verify the quality of iodixanol API from Asian manufacturers?
A: Buyers should review Certificates of Analysis, conduct GMP audits, and obtain samples for independent laboratory testing to confirm purity and compliance with pharmacopeial standards.

Q2: What regulatory considerations should be prioritized when sourcing API globally?
A: Ensuring API suppliers hold valid GMP certifications from recognized authorities (FDA, EMA, WHO), and that the manufacturing facilities are regularly inspected, is vital for regulatory compliance and product approval.

Q3: Are there supply chain risks associated with sourcing iodixanol API from China or India?
A: Yes. Risks include geopolitical issues, transportation delays, and quality variability. Diversifying suppliers and establishing long-term, transparent partnerships helps mitigate these risks.

Q4: What trends are shaping the future of API sourcing for contrast agents like Amipaque?
A: Growing capacities in Asia, technological advancements, regulatory harmonization, and increased focus on quality assurance are shaping the future of API sourcing for contrast media.

Q5: How does supply chain diversification impact the procurement of iodixanol API?
A: Diversification reduces dependency on single sources, minimizes risk of shortages, and helps maintain consistent supply of high-quality API for manufacturing Amipaque.

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Sources:
[1] “Global API Market for Contrast Media,” Pharmaceutical Technology, 2022.
[2] “Regulatory Standards for Radiographic Contrast Agents,” EMA Guidelines, 2023.
[3] “Indian Pharmaceutical Industry Overview,” Pharmexec, 2022.
[4] “Asian API Manufacturing Capabilities,” International Trade Administration Report, 2023.
[5] “Quality Assurance in API Production,” WHO Guidelines, 2021.