Bulk Pharmaceutical API Sources for ISOVUE-300

Bulk Pharmaceutical API Sources for ISOVUE-300

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-848-224
Amadis Chemical		A834067
AKos Consulting & Solutions		AKOS015891034
AbaChemScene		CS-2917
MedChemexpress MCE		HY-B0684
Key Organics/BIONET		KS-1421
BOC Sciences		60166-93-0

Bulk Active Pharmaceutical Ingredient (API) Sources for ISOVUE-300

Last updated: July 29, 2025

Introduction

ISOVUE-300 (iohexol) is a nonionic, low-osmolar contrast agent widely used in diagnostic imaging, particularly during angiography, computed tomography (CT), and myelography. As a contrast agent, it enhances the visibility of blood vessels, tissues, and hollow organs. Its pharmaceutical efficacy hinges on the quality and purity of its active pharmaceutical ingredient (API)—iohexol. Securing reliable, high-quality API sources is critical for manufacturers to ensure consistent product quality, regulatory compliance, and supply chain stability.

This article examines the global landscape of bulk API sources for ISOVUE-300, emphasizing key manufacturers, geographic distribution, quality considerations, and supply chain dynamics.

Global API Manufacturing Landscape for Iohexol

Major API Manufacturers

The production of iohexol involves complex chemical synthesis processes, demanding stringent quality controls and advanced manufacturing capabilities. Several pharmaceutical and chemical companies are notable for producing the API used in ISOVUE-300:

• Bayer Healthcare (Germany)
  Bayer was the original developer of iohexol and remains a significant supplier at the API level. Their expertise in contrast media positions them as a trusted source for manufacturers worldwide, ensuring high-grade API conforming to regulatory standards such as USP, EP, and JP (Japanese Pharmacopoeia).

• Jiangsu Hengrui Medicine Co., Ltd. (China)
  This leading Chinese pharmaceutical company has expanded its portfolio into contrast media APIs, including iohexol. The company invests heavily in manufacturing infrastructure aligned with international standards, making it a competitive source for Asia-based and global markets.

• Dong-A ST Co., Ltd. (South Korea)
  Dong-A ST manufactures a range of contrast agents and APIs, including iohexol. Their facilities operate under strict quality controls, with a focus on serving the Asian market and exporting to other regions.

• Liuhe Pharmaceutical (China)
  Known for producing contrast media compounds, Liuhe Pharmaceutical has developed capabilities in API manufacturing, including iohexol, with a focus on meeting international quality benchmarks.

• United States Pharmacopeia (USP) Monographs
  Some US-based API manufacturers produce iohexol under strict regulatory oversight, primarily for domestic and export markets.

Emerging and Specialty API Suppliers

The API market for iohexol also includes smaller, specialized producers capable of meeting specific regulatory or supply chain demands. These companies often serve niche markets, customized formulations, or contract manufacturing needs.

• APIs from Indian Manufacturers
  Indian pharmaceutical companies like Granules India and Aurobindo Pharma have invested in contrast media APIs, including iohexol. Their cost-effective production and growing scale make them potential sources, especially for markets emphasizing affordability.

• European Contract Manufacturing Organizations (CMOs)
  Several CMOs in Europe specialize in high-potency APIs and may serve as secondary sources for iohexol, especially for formulations requiring specific excipient compatibility.

Quality and Regulatory Considerations

Manufacturers seeking API sources for ISOVUE-300 must emphasize quality attributes like high purity (>99%), low endotoxin levels, and compliance with Good Manufacturing Practices (GMP). Regulatory approvals and certifications, such as US FDA, EMA, or China NMPA, serve as critical indicators of API quality and reliability.

ISO Certification, batch-to-batch consistency, and comprehensive analytical data (HPLC, GC, residual solvents, heavy metals) are essential for market acceptance. Many manufacturers also pursue strategies for API validation, including stability studies and impurity profiling, to ensure compliance with pharmacopoeial standards.

Supply Chain Dynamics and Risks

The API market for iohexol is characterized by moderate supply chain risks, influenced by geopolitical factors, production capacity constraints, and global demand fluctuations. Suppliers in Germany, China, and South Korea dominate, but recent geopolitical tensions and trade policies pose potential disruptions.

Consolidating multiple supply sources, including secondary suppliers, helps mitigate risks. Transparency in supply chain contracts and establishing long-term partnerships are strategic priorities for generic and innovator companies alike.

Key Considerations for Buyers

• Regulatory Compliance: Verify supplier certifications, including GMP compliance and pharmacopoeial adherence.

• Quality Assurance: Request detailed analytical reports, certificates of analysis (COA), and stability data.

• Supply Reliability: Assess production capacity, delivery timelines, and contingency plans amid geopolitical or logistical challenges.

• Cost and Lead Time: Balance quality with cost-effectiveness while considering lead times, especially when sourcing from emerging markets.

Conclusion

The selection of bulk API sources for ISOVUE-300 (iohexol) is pivotal for manufacturers aiming to ensure high-quality contrast media products. Leading suppliers, primarily in Europe, China, South Korea, and India, offer a spectrum of options influenced by quality, regulatory status, and supply stability. Strategic sourcing—incorporating multiple suppliers, rigorous quality assessments, and adherence to GMP standards—remains essential for maintaining seamless production and regulatory compliance.

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Key Takeaways

• Bayer Healthcare remains the original and a trusted primary API supplier for iohexol, especially for high-value, regulated markets.
• Chinese and South Korean manufacturers, such as Jiangsu Hengrui and Dong-A ST, are expanding their API production capabilities, offering cost-effective alternatives.
• Quality assurance, regulatory compliance, and supply chain resilience are critical considerations when sourcing iohexol API.
• Diversifying sources and establishing long-term relationships mitigate risks related to geopolitical tensions and capacity constraints.
• Buyers should rigorously evaluate suppliers' certifications, analytical data, and manufacturing practices to ensure product integrity.

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FAQs

1. Is Bayer Healthcare still the primary manufacturer of iohexol API?
Yes, Bayer remains a prominent producer of iohexol API, owing to its historical development and extensive experience in contrast media. Its products are widely used in regulated markets, ensuring high standards of quality.

2. Are Chinese and Korean API manufacturers compliant with international standards?
Many Chinese and Korean manufacturers have invested heavily in GMP certification and adhere to international pharmacopoeial standards, making their APIs suitable for global markets. Due diligence and certification verification are recommended.

3. How does the cost of API from emerging markets compare to established suppliers?
APIs from China, India, and South Korea generally offer cost advantages due to lower manufacturing costs. However, buyers must ensure that quality and regulatory compliance are not compromised.

4. What are the risks associated with sourcing iohexol API from multiple suppliers?
Risks include inconsistent quality, supply disruptions, or regulatory discrepancies. Proper qualification, audits, and quality agreements mitigate these risks.

5. How can manufacturers ensure consistent API quality across batches?
Implement robust quality control measures, request comprehensive analytical and stability data, and establish supplier qualification programs to monitor batch consistency and regulatory compliance.

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References

[1] Bayer AG, "Contrast Media," Bayer Pharmaceuticals, 2022.
[2] Jiangsu Hengrui Medicine Co., Ltd., "API Production and Quality," Official Website.
[3] European Medicines Agency (EMA), "Guidelines on API Quality," 2021.
[4] US Pharmacopeia, "Iohexol Monograph," USP 45, 2021.
[5] World Health Organization, "Guide to Good Manufacturing Practices," 2020.