Bulk Pharmaceutical API Sources for IOPAMIDOL-250

Bulk Pharmaceutical API Sources for IOPAMIDOL-250

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-250

Last updated: July 30, 2025

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Introduction

In the pharmaceutical supply chain, sourcing high-quality Active Pharmaceutical Ingredients (APIs) is critical to ensuring drug efficacy, safety, and compliance with regulatory standards. Iopamidol-250, a non-ionic iodinated contrast agent used in diagnostic imaging, is no exception. Its market depends on reliable, compliant sources that can supply consistent quality at scale. This article assesses leading global API manufacturers and suppliers for Iopamidol-250, analyzing their capabilities, regulatory adherence, and strategic positioning within the pharmaceutical industry.

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Overview of Iopamidol-250 API Market

Iopamidol, primarily supplied as the 250 mg/mL solution, is synthesized through complex multi-step chemical processes involving iodine incorporation, purification, and sterility assurance. Because of its pharmaceutical importance, API sourcing depends heavily on companies with proven manufacturing excellence, robust quality management systems, and compliance with international standards such as cGMP (current Good Manufacturing Practice).

The global demand for Iopamidol-250 is driven predominantly by diagnostic imaging centers, hospitals, and radiology clinics. As the market for contrast agents grows, so does the need for trustworthy API suppliers. Leading suppliers often align with major pharmaceutical and biotechnology companies or operate as contract manufacturing organizations (CMOs) possessing extensive experience with iodinated contrast media.

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Major API Suppliers and Sources for Iopamidol-250

1. GE Healthcare (Part of GE)

GE Healthcare is a dominant provider of contrast media and related APIs, including Iopamidol. The company maintains extensive manufacturing facilities globally, including specialized plants tailored for radiocontrast agents. As a pioneer in contrast media, GE’s API manufacturing adheres strictly to cGMP and ISO standards, ensuring high-quality API supply to meet worldwide regulatory requirements.

• Capabilities: Large-scale synthesis, quality assurance, global distribution, and R&D capabilities.
• Regulatory Standing: FDA-approved, EMA-compliant, and certified under ISO standards.
• Supply Stability: Long history of consistent supply with established logistical networks.

2. Bracco Imaging (Italy)

Bracco is a major global player specializing in contrast agents, including Iopamidol. The company has multiple manufacturing sites in Italy, adhering to stringent quality standards aligned with the European Medicines Agency (EMA). Bracco's APIs for Iopamidol are produced under strict cGMP conditions, ensuring high purity and batch-to-batch consistency.

• Capabilities: End-to-end manufacturing, from synthesis to finished APIs.
• Regulatory Standing: EMA-approved; also complies with FDA cGMP standards for export.
• Market Focus: Serving both European and international markets with reliable supply channels.

3. Guerbet Group

Guerbet specializes in contrast media and imaging solutions. The company operates integrated manufacturing facilities capable of API synthesis and formulation. Known for stringent quality control, Guerbet produces APIs that meet international pharmaceutical standards.

• Capabilities: Comprehensive API development and manufacturing, with R&D focus on innovative contrast agents.
• Regulatory Standing: Approval and compliance with FDA, EMA, and other regulatory regimes.
• Supply Reliability: Long-term supplier with proven track record for high-quality API supply.

4. Jianlong Pharmaceutical Co. Ltd. (China)

As a leading Chinese API manufacturer, Jianlong has invested heavily in iodinated contrast agents, including Iopamidol. The company’s facilities are approved under multiple regulatory regimes, including GMP certifications recognized globally (e.g., China CFDA, US FDA, EMA certifications).

• Capabilities: Large-scale API synthesis, with growing international distribution.
• Regulatory Standing: Produces APIs compliant with international standards, though regulatory approval varies by country.
• Cost Advantage: Competitive pricing due to manufacturing efficiency.

5. WuXi AppTec

WuXi is a prominent CMO with extensive API manufacturing capabilities, including iodinated contrast media. Their facilities incorporate advanced process development, quality controls, and compliance measures.

• Capabilities: Custom synthesis, scale-up, and cGMP manufacturing for APIs.
• Regulatory Standing: Compliant with FDA, EMA, and other regulators; supports global registration.
• Flexibility: Offers tailored solutions for both clinical and commercial supply.

6. Piramal Pharma Solutions (India)

Piramal is recognized for its API manufacturing expertise across multiple therapeutic segments, including radiocontrast agents. Its facilities hold multiple approvals, ensuring reliable supply of Iopamidol APIs per regulatory standards.

• Capabilities: Large-volume API synthesis, extensive quality controls.
• Regulatory Standing: GMP-compliant; exports to global markets.
• Cost Perspective: Cost-effective sourcing, appealing for large-volume needs.

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Regulatory and Quality Considerations

Ensuring compliance with cGMP, ISO standards, and country-specific regulations (FDA, EMA, CFDA) is fundamental when sourcing Iopamidol-250 API. Manufacturers like GE Healthcare, Bracco, and Guerbet hold established regulatory recognition, enabling seamless integration into global supply chains. Emerging suppliers, particularly those in China and India, have improved compliance over the years, but vigilance in documentation and certifications remains essential.

The purity of API, control over residual solvents, heavy metals, and impurities, as well as batch-to-batch consistency, are critical determinants of supplier selection. Certification transparency, audit readiness, and proactive quality management underpin supplier reliability.

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Strategic Factors in API Sourcing for Iopamidol-250

• Supply Reliability: Establishing long-term partnerships with suppliers bearing robust manufacturing capacity and supply chain resilience reduces risk of shortages.
• Cost Efficiency: Competitive pricing often influences sourcing decisions, especially from high-volume API manufacturers in Asia.
• Regulatory Compliance: Preference for suppliers with approved cGMP facilities and proven regulatory histories minimizes market entry delays.
• Quality & Purity: Verified data on API specifications, batch records, and compliance with pharmacopoeia standards (USP, EP, BP) assures product safety.

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Emerging Trends and Future Outlook

The global API market for iodinated contrast agents faces increasing pressure to innovate, particularly with a focus on reducing iodine-related toxicity and improving imaging quality. Manufacturers investing in process innovation and cleaner synthesis pathways are likely to gain strategic advantages. Additionally, the increasing quality standards imposed by regulators and buyers drive suppliers to adopt more rigorous manufacturing and quality assurance protocols.

Availability of APIs from multiple sourcing regions, including North America, Europe, and Asia, enhances supply chain resilience. However, geopolitical factors, trade policies, and regulatory harmonization will influence sourcing patterns.

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Key Takeaways

• Leading global API manufacturers for Iopamidol-250 include GE Healthcare, Bracco, Guerbet, Jianlong Pharmaceutical, WuXi AppTec, and Piramal Pharma Solutions.
• Established manufacturers with proven regulatory compliance and steady manufacturing capacity are preferred to minimize supply risks.
• Chinese and Indian suppliers offer cost advantages but require diligent verification of GMP compliance and regulatory approvals.
• Strategic sourcing decisions should balance cost, quality, regulatory compliance, and supply chain reliability.
• Continuous monitoring of supplier certifications, quality data, and market developments is essential for long-term success.

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FAQs

Q1: What are the primary regulatory considerations when sourcing Iopamidol-250 API?
A: Ensuring the API supplier holds relevant cGMP certifications, complies with major health authority standards (FDA, EMA), and provides thorough documentation on purity, residuals, and manufacturing processes.

Q2: How does supplier location impact API quality and supply stability?
A: Established suppliers in Europe and North America typically demonstrate stringent quality controls and regulatory compliance, offering higher assurance of quality. Asian suppliers may provide cost advantages but require verification of GMP adherence and quality systems.

Q3: What are common quality parameters to evaluate in Iopamidol API sourcing?
A: Purity (>99%), residual solvents, heavy metals, microbial contamination, endotoxin levels, and batch consistency are critical parameters.

Q4: How can buyers mitigate supply risks associated with API sourcing?
A: Diversify suppliers across regions, establish long-term contracts, conduct regular audits, and verify regulatory compliance to ensure continuous supply.

Q5: What future developments may influence API sourcing for iodinated contrast agents?
A: Innovations in manufacturing processes, stricter regulatory standards, and geopolitical shifts can reshape sourcing strategies, emphasizing quality, safety, and supply chain resilience.

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References

1. [1] International Pharmaceutical Federation (FIP). "Guidelines on Quality Management of APIs."
2. [2] CEPI (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme). "Good Manufacturing Practice: Essential Requirements."
3. [3] Market reports: "Global Contrast Media Market," MarketsandMarkets, 2022.
4. [4] Company disclosures and regulatory filings (GE Healthcare, Bracco, Guerbet, Jianlong, WuXi, Piramal).
5. [5] World Health Organization (WHO). "Good Regulatory Practices Guide" 2021.

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