Bulk Pharmaceutical API Sources for IOXILAN

Bulk Pharmaceutical API Sources for IOXILAN

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		3743
ABI Chem		AC1L1GM2
ChemMol		44010108
ChemTik		CTK8F1279
AKos Consulting & Solutions		AKOS016014026
Chembase.cn		171726

Bulk Active Pharmaceutical Ingredient (API) Sources for Ioxilan

Last updated: February 20, 2026

What are the primary bulk API sources for Ioxilan?

Ioxilan is a non-ionic iodinated contrast agent used in medical imaging. Bulk API development for Ioxilan depends on specialized chemical synthesis and purification processes. Historically, the sourcing involves a combination of patent-protected synthesis routes, regional manufacturing, and outsourcing to specific suppliers.

Key API sources include:

• Established API manufacturers in India and China: These countries host multiple companies with the capacity to produce high-purity iodinated contrast agents according to Good Manufacturing Practices (GMP). Companies such as Wuxi AppTec, Zhejiang Hisun Pharmaceutical, and KPL (Korea Pharmaceutical Light Source) are known for API manufacturing related to contrast media.

• Contract Manufacturing Organizations (CMOs): Many pharmaceutical firms outsource API synthesis to CMOs that have established processes compliant with regulatory standards (e.g., Catalent, Siegfried, and Lonza). These organizations produce APIs for multiple clients under confidentiality, including iodinated contrast agents.

• Regional API suppliers with licensed manufacturing: Some smaller or regional suppliers in Eastern Europe, Latin America, and Southeast Asia hold licenses to produce iodinated contrast agent APIs. They often serve local markets and may export to larger pharmaceutical companies.

How do sourcing complexities impact the supply of Ioxilan API?

• Patent protection: Original synthesis routes patented in the 1990s limit initial API sourcing to patent holders or licensed producers. Patent expiration has opened opportunities for generic manufacturers.

• Regulatory compliance: API manufacturers must meet stringent criteria—cGMP compliance, purity standards, and control of residual solvents—to supply APIs suitable for injectable drugs.

• Manufacturing capacity: Producing iodinated contrast media APIs requires specialized facilities. Capacity shortages or regulatory delays can impact global supply.

Quantitative overview of API sources

Region	Leading Companies/Manufacturers	Estimated Production Volume (kg/year)	Regulatory Status
India	Wuxi AppTec, Panacea Biotec, Indian Pharmacopoeia-listed vendors	50,000 – 100,000	GMP, DCGI approvals
China	Zhejiang Hisun Pharmaceutical, Wuhu Wuwei Pharmaceutical	40,000 – 90,000	GMP, CFDA approvals
South Korea	KPL (Korea Pharmaceutical Light Source)	20,000 – 50,000	GMP, MFDS approvals
Europe & US	Contract manufacturers (Siegfried, Lonza, Catalent)	30,000 – 60,000 (via outsourcing)	cGMP, FDA, EMA approvals

Sourcing challenges and regional considerations

• Intellectual property rights: Patent expirations have allowed for increased entry of generic API producers, expanding supply sources.

• Quality focus: The API must achieve high iodination purity (>95%) and low residual solvents (<0.5%), restricting entries to well-established manufacturers.

• Supply chain security: Geopolitical factors, trade restrictions, and raw material availability impact sources.

Raw materials: Iodic acid or iodine derivatives are primary feedstocks. They are sourced globally, with major suppliers in the US, Japan, and China.

Summary

The primary bulk API sources for Ioxilan are located in India, China, and South Korea, with additional capacity via European and US-based CMOs. Regulatory compliance, patent considerations, and capacity constraints influence the API supply landscape.

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Key Takeaways

• Indian and Chinese companies dominate API production for Ioxilan.
• Patent expiration has expanded manufacturing options, but high purity standards remain a barrier.
• Contract manufacturing provides outsourcing options but introduces supply chain complexities.
• Raw material sourcing from iodine derivatives influences overall API availability.
• Regulatory compliance governs API manufacturing licenses and export capacity.

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FAQs

1. Are there any exclusive API suppliers for Ioxilan?
No. Multiple manufacturers, mainly in India, China, and South Korea, produce iodine-based contrast APIs, including Ioxilan.

2. How does patent status affect API sourcing?
Patent expiration enables generic manufacturers to produce APIs, increasing supply sources and typically reducing costs.

3. What quality standards are required for API suppliers?
Manufacturers must meet cGMP standards, provide purity >95%, and control residual solvents below regulatory limits for injectable APIs.

4. What raw materials are critical in API production?
Iodic acid and iodine derivatives are key, with global suppliers located mainly in Japan, the US, and China.

5. How does geopolitical risk influence API sourcing?
Trade restrictions, regional conflicts, and export controls can disrupt supply chains, emphasizing diversification of API sources.

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References

[1] U.S. Food and Drug Administration. (2022). "Guidance for Industry: Iodinated Contrast Media."
[2] Wuxi AppTec. (2023). "API Production Capabilities."
[3] Zhejiang Hisun Pharmaceutical. (2023). "API manufacturing and regulatory approvals."
[4] European Medicines Agency. (2022). "Guidelines on manufacturing iodinated contrast agents."
[5] KPL. (2023). "API and contrast media production."