Bulk Pharmaceutical API Sources for CONRAY

Bulk Pharmaceutical API Sources for CONRAY

Vendor	Vendor Homepage	Vendor Sku	API Url
LGC Standards		DRE-C14349000
Alfa Chemistry		13087-53-1
MuseChem		M132822
BOC Sciences		13087-53-1
THE BioTek		bt-271808

Bulk Active Pharmaceutical Ingredient (API) Sources for Conray

Last updated: July 28, 2025

Introduction

Conray, a reputed radiopaque contrast agent, primarily contains Iodized Oil, offering diagnostic imaging utility, especially in angiography, myelography, and lymphography. Its efficacy hinges on the high purity and consistent quality of its Active Pharmaceutical Ingredient (API). As the pharmaceutical industry emphasizes supply chain robustness, identifying reliable bulk API sources for Conray's key ingredient is paramount. This analysis explores the global landscape of API manufacturers and suppliers capable of providing high-grade Iodized Oil suitable for pharmaceutical use, focusing on quality standards, regulatory compliance, and supply capabilities.

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Overview of API Requirements for Conray

Conray's API, Iodized Oil, must meet rigorous pharmacopeial standards, including United States Pharmacopeia (USP), European Pharmacopoeia (EP), or other applicable pharmacopoeial monographs. Critical parameters include:

• Purity: Typically > 99% iodine content with minimal contaminants
• Particle Size: Suitable for injection and imaging procedures
• Stability: Chemically stable over shelf life
• Sterility: Suitable for parenteral administration when required

Manufacturers and suppliers must adhere to Good Manufacturing Practices (GMP), ensure quality validation, and possess robust quality control labs.

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Major API Manufacturing Regions and Key Players

1. Asia-Pacific

a. China

China hosts several large-scale chemical and pharmaceutical manufacturers capable of producing iodine-based compounds. Notable firms include:

• Zhejiang Huahai Pharmaceutical Co., Ltd.
• Shandong Xinhua Pharmaceutical Company

While primarily focused on other iodine derivatives, some Chinese firms possess the technical expertise and facilities for high-purity Iodized Oil production, often exporting to global markets under strict quality controls. Chinese API firms generally adhere to international GMP standards, although regulatory recognition varies.

b. India

India is a significant pharmaceutical manufacturing hub, with firms producing APIs for domestics and exports.

• Biochem Pharmaceutical Industries Ltd.
• Gujarat Fluorochemicals Ltd.

These companies have capabilities for iodine chemistry and are compliant with regulatory standards like WHO-GMP, facilitating supply of high-quality APIs, including Iodized Oil. Nonetheless, capacity for large-volume, high-purity API production specifically for radiological contrast agents may still be limited.

2. Europe

Europe maintains stringent regulatory oversight and hosts reputed API manufacturers.

• BASF SE (Germany)
• Fresenius SE & Co. KGaA (Germany)

BASF produces pharmaceutical-grade iodine compounds, including iodine solutions and derivatives. Their extensive experience, adherence to GMP, and global certification make them dependable sources.

• Merck KGaA (Germany)
• Evonik Industries (Germany)

These firms are involved in iodine chemistry and can supply high-purity iodine compounds suitable as API precursors for Iodized Oil.

3. North America

North American manufacturers are known for rigorous quality standards.

• BASF Corporation (U.S.)
• Iogen Corporation (Canada)

While primarily focused on chemical intermediates, some suppliers provide iodine derivatives for pharmaceutical use, subject to strict regulatory approvals.

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Specialist API Suppliers for Iodized Oil

Few companies specialize exclusively in Iodized Oil API; most are integrated producers of iodine derivatives used across multiple applications.

Notable Companies

• Zhejiang Huahai Pharmaceutical Co., Ltd. (China): possesses a broad portfolio of iodine compounds, including APIs suitable for imaging agents.
• Viatris (USA): offers various pharmaceutical-grade iodine products, potentially adaptable for diagnostic formulations.
• Alfa Aesar (a Thermo Fisher Scientific brand): supplies iodine chemicals with pharmaceutical-grade quality.

Third-Party API Brokers

Certain brokers and trading companies facilitate procurement from various manufacturers, ensuring supply chain flexibility but requiring thorough qualification due diligence.

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Quality and Regulatory Considerations

• GMP Compliance: Only API suppliers with valid GMP certification can meet the stringent quality needed for injectable contrast agents.
• Regulatory Approvals: Suppliers must have documentation for regulatory submissions (e.g., DEA registration, FDA approval, EMA batch certifications).
• Documentation: Certificates of Analysis (CoA), stability data, and purity profiles are essential for validation and regulatory review.

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Supply Chain and Logistics Dynamics

Availability of Iodized Oil API depends on global iodine supply, geopolitical stability, and manufacturing capacity. Key considerations include:

• Lead Time: Suppliers with established API manufacturing lines can provide faster delivery.
• Scale: Large-scale capacity ensures consistent supply to meet global demand.
• Cost: While quality is paramount, pricing competitiveness influences supplier selection.

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Emerging Trends & Future Outlook

• Development of Synthetic Alternatives: Ongoing research aims to develop alternative compounds with comparable imaging qualities, potentially impacting future API sourcing strategies.
• Localization of API Production: Strategic shifts toward regional API manufacturing hubs aim to reduce lead times and supply risks.
• Regulatory Harmonization: Efforts by bodies like ICH promote unified standards for API approval, easing cross-border procurement.

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Conclusion

The procurement of bulk API for Conray hinges on accessing high-quality, GMP-compliant Iodized Oil or its precursors. Reputable manufacturers from Europe, North America, and China emerge as primary sources given their capabilities and regulatory adherence. Thorough vendor qualification, quality validation, and supply chain management underpin reliable sourcing strategies. As global demand for radiological contrast agents persists, fostering collaborations with established API producers will enhance supply security and regulatory compliance.

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Key Takeaways

• Prioritize GMP-certified suppliers: Ensure API quality aligns with pharmacopeial standards for safety and efficacy.
• Evaluate regional supplier capabilities: European and North American manufacturers typically offer higher assurance, though Chinese and Indian producers can be competitive if compliance is verified.
• Secure comprehensive documentation: Certificates of Analysis, stability data, and regulatory approvals are critical for validation and registration.
• Consider supply chain stability: Larger manufacturers with scalable capacity mitigate risks, especially amid global supply disruptions.
• Stay informed on industry developments: Advances in synthetic chemistry and regional manufacturing hubs influence future sourcing options.

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FAQs

1. Can Iodized Oil API be sourced from multiple suppliers for Conray?
Yes, diversifying sources enhances supply security. It is crucial, however, to verify each supplier’s GMP compliance and conduct thorough quality assessments.

2. What regulatory standards must API suppliers for Conray meet?
Suppliers must adhere to pharmacopeial standards (USP, EP), comply with GMP regulations, and provide relevant certifications for regulatory submissions across target markets.

3. Are Chinese API manufacturers suitable for pharmaceutical-grade Iodized Oil?
Some Chinese firms possess GMP certification and can supply quality API, but extensive qualification and verification processes are recommended before procurement.

4. How does API purity impact Conray’s effectiveness?
High purity ensures optimal contrast performance, reduces side effects, and aligns with safety regulations. Impurities can compromise image quality or cause adverse reactions.

5. What trends could influence future API sourcing for radiological contrast agents?
Development of synthetic alternatives, regional manufacturing initiatives, and harmonization of global standards are key trends shaping future supply dynamics.

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References

1. USP Monograph for Iodinated Oil, USP-NF.
2. European Pharmacopoeia 10th Edition, Iodinated Oil specifications.
3. Industry reports on global iodine and iodine-based API manufacturing capabilities.
4. Company's official websites and regulatory filings.