Bulk Pharmaceutical API Sources for OPTIRAY 240

Bulk Pharmaceutical API Sources for OPTIRAY 240

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-536
Molport		MolPort-005-938-391
Amadis Chemical		A842365

Bulk Active Pharmaceutical Ingredient (API) Sources for: OPTIRAY 240

Last updated: August 5, 2025

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Introduction

Optiray 240, a proprietary radiocontrast agent, primarily contains iohexol—a nonionic, water-soluble iodine compound used extensively in medical imaging. Ensuring a reliable, high-quality supply chain of the active pharmaceutical ingredient (API)—iohexol—is critical for pharmaceutical manufacturers, distributors, and healthcare providers. This article examines key global suppliers of iohexol API, regulatory considerations, sourcing strategies, and market dynamics integral for stakeholders involved with Optiray 240.

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Understanding Iohexol: The Core API in Optiray 240

Iohexol is a third-generation, nonionic, low-osmolar contrast medium. It facilitates enhanced visualization of vascular structures, organs, and tissues during diagnostic imaging procedures like computed tomography (CT) scans. The API’s chemical properties demand stringent manufacturing standards, including purity levels exceeding 99% and adherence to pharmacopeial specifications (USP, EP, JP). The stability and safety profile directly depend on API quality, influencing Optiray 240's performance and regulatory compliance.

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Major Global API Suppliers for Iohexol

Multiple entities globally produce and supply high-grade iohexol API, predominantly targeting the pharmaceutical and radiology markets. The list of reputable sources underscores both regional diversification and technological competitiveness.

1. NEUROGEN Pharma GmbH (Germany)

Based in Germany, NEUROGEN Pharma is recognized for its specialized synthesis and supply of iohexol API. Their manufacturing aligns with European Good Manufacturing Practices (GMP), ensuring product consistency, high purity levels, and compliance with strict regulatory standards. They serve as a direct supplier for many European pharmaceutical companies developing contrast agents like Optiray 240.

• Market positioning: Premium API supplier with a focus on quality and regulatory conformity.

2. GE Healthcare (United States/Global)

While GE Healthcare is primarily known for finished contrast media products, they also produce iohexol API for internal use and licensing to third-party manufacturers. Their vertically integrated manufacturing processes and substantial R&D investment enable consistent API quality and scalability. Licensing agreements with regional manufacturers extend GE’s influence into markets like Asia and Latin America.

• Market positioning: Industry leader with robust API manufacturing capabilities and global reach.

3. Shanghai Detai Pharmaceutical Co., Ltd. (China)

A notable Chinese manufacturer, Shanghai Detai Pharmaceutical, produces GMP-compliant iohexol API. The company's facilities are certified according to Chinese pharmacopeial standards, with increasing efforts to meet international GMP requirements (e.g., EMA, FDA). Cost competitiveness and strategic location make them an attractive source for bulk API procurement, especially for Asian markets.

• Market positioning: Cost-effective supplier with expanding international compliance.

4. Zhejiang Haizheng Pharmaceutical Co., Ltd. (China)

Specialized in contrast media APIs, Zhejiang Haizheng offers high-quality iohexol API compliant with CE, FDA, and other regulatory standards. Their focus on quality control and extensive experience in radiocontrast agents secure them a prominent position in the API supply chain.

• Market positioning: Reliable supplier targeting regulatory markets worldwide.

5. Mylan/NATCO Pharmaceutical (India)

Mylan's predecessor, NATCO, has long-standing expertise in contrast media manufacturing, including iohexol API. Their facilities are GMP-certified, and they serve both domestic and international markets with competitive pricing and consistent quality.

• Market positioning: Cost-efficient regional supplier with global export capabilities.

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Emerging and Regional API Sources

Particularly in response to the growing demand for contrast agents, several emerging players are gaining traction:

• CordenPharma (Germany & US): Offers specialty intermediates and APIs, including iohexol, leveraging advanced synthesis technologies.
• Sichuan Tongsheng Pharmaceutical (China): Focused on regional markets with expanding quality certifications.
• A.S.I.C. (Italy): Smaller scale but recognized for high purity APIs tailored toward niche formulations.

Regulatory Considerations and Certification Standards

Sourcing iohexol API necessitates compliance with global pharmaceutical regulations. Key certifications include:

• GMP (Good Manufacturing Practices): Essential for ensuring batch-to-batch consistency and safety.
• EO (European Pharmacopoeia), USP, JP specifications: Confirm API meets specified purity, residual solvents, and impurity profiles.
• Accreditations: ISO, GLP, and specific regional certifications influence supplier credibility.

Market access and acceptance largely hinge on these credentials, especially for licensed formulations like Optiray 240.

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Strategic Sourcing Approaches

The choice of API source for Optiray 240 hinges on multiple factors:

• Quality assurance: Prioritize suppliers with proven regulatory compliance and rigorous QC protocols.
• Cost considerations: Engage with emerging markets (China, India) for competitive pricing, balanced with quality assurance.
• Supply chain reliability: Evaluate suppliers’ manufacturing capacity, geopolitical stability, and logistics capabilities.
• Regulatory alignment: Prefer suppliers with established certifications matching target markets’ regulatory needs.

Establishing long-term partnerships, often through licensing agreements, is advised to mitigate supply disruptions.

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Market Dynamics and Future Outlook

The global iohexol API market is expected to grow alongside increasing demand for diagnostic imaging procedures. Key trends include:

• Technological innovation: Advanced synthesis methods improve API purity and reduce impurities.
• Regulatory harmonization: Efforts by agencies like EMA and FDA streamline approval processes, incentivizing higher quality standards among Chinese and Indian suppliers.
• Geographical diversification: Companies seek regional API sources to mitigate risks associated with supply chain disruptions.

Intensifying competition and regulatory scrutiny will likely improve API quality and reduce procurement costs over time.

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Key Takeaways

• Diverse sourcing options exist worldwide, with leading providers in Europe, North America, and Asia.
• Regulatory compliance (GMP, pharmacopeial standards) is non-negotiable for API procurement.
• Chinese and Indian manufacturers offer cost advantages but require thorough vetting of quality certifications.
• Long-term partnerships with reputable API suppliers mitigate risks and ensure supply continuity.
• Market trends favor technological advancement and regional diversification, enhancing supply chain resilience.

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Frequently Asked Questions

1. What are the main challenges in sourcing iohexol API for Optiray 240?
Ensuring consistent quality, regulatory compliance, and reliable supply are key challenges. Variability in manufacturing practices and geopolitical factors can impact procurement stability.

2. How does regulatory approval affect API sourcing for Optiray 240?
Manufacturers must verify that API suppliers meet regulatory standards (GMP, pharmacopeial specifications). Non-compliance can delay product approvals and market entry.

3. Can emerging suppliers from China and India reliably provide high-quality iohexol API?
Yes, many have achieved GMP certification and international quality standards. Nonetheless, rigorous qualification and validation processes are essential before procurement.

4. What role does API purity play in the safety and efficacy of Optiray 240?
High API purity (>99%) reduces impurities that can cause adverse reactions, ensuring safety and optimal contrast performance crucial for diagnostic accuracy.

5. How might geopolitical factors influence API sourcing strategies?
Tariffs, trade policies, and regional stability can impact costs and supply chains. Diversification and establishing local manufacturing partnerships help mitigate risks.

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References

[1] Scientific literature on iohexol synthesis and quality standards, European Pharmacopoeia.
[2] Market reports on radiocontrast agent API suppliers, PharmSource and IQVIA.
[3] Regulatory guidelines from EMA, FDA, and other authorities concerning contrast media manufacturing.
[4] Industry insights on global API manufacturing capabilities and compliance trends.
[5] Company disclosures and product datasheets from key API suppliers.

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Note: Stakeholders should perform due diligence and validation activities before establishing new supply relationships, aligning sourcing decisions with quality, regulatory, and strategic objectives.