Bulk Pharmaceutical API Sources for IODOXAMATE MEGLUMINE

Bulk Pharmaceutical API Sources for IODOXAMATE MEGLUMINE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		23620848
001Chemical		DY557968
BenchChem		B1261165

Bulk Active Pharmaceutical Ingredient (API) Sources for: IODOXAMATE MEGLUMINE

Last updated: August 4, 2025

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Introduction

Iodoxamate Meglumine, a radiopaque iodine-based compound, is pivotal in diagnostic radiology, especially in angiography and contrast-enhanced imaging procedures. As a derivative of iodine-containing compounds, its pharmaceutical manufacturing hinges on sourcing high-purity active pharmaceutical ingredients (APIs) that meet stringent regulatory standards. This article assesses the landscape of bulk API sources for Iodoxamate Meglumine, emphasizing supplier reliability, quality assurance, and strategic procurement practices critical for pharmaceutical entities.

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Overview of Iodoxamate Meglumine

Iodoxamate Meglumine is a water-soluble iodinated contrast agent used in diagnostic imaging. The API comprises iodine conjugated within a meglumine salt, facilitating its role as a radiocontrast medium. The synthesis of this API involves complex iodination and subsequent conjugation with meglumine to ensure efficacy and safety. The quality of raw materials directly affects the final product’s imaging performance and patient safety.

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Key Raw Materials and Precursors

The production of Iodoxamate Meglumine primarily depends on:

• Iodinating agents: Elemental iodine (I₂), which is further processed for aromatic iodination.
• Solubilizing agents: Meglumine (N-methyl-D-glucamine), required for forming the contrast agent.
• Intermediate chemicals: Various organic compounds facilitating iodination pathways, including aromatic compounds and amino derivatives.

The supply chain reliability of these raw materials influences the stability of global API production pipelines for Iodoxamate Meglumine.

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Global API Suppliers for Iodoxamate Meglumine

Currently, the API for Iodoxamate Meglumine is sourced through a combination of regional specialists and major global pharmaceutical excipient suppliers. Given the complexity, most API manufacturing occurs within established facilities adhering to ICH (International Council for Harmonisation) guidelines and cGMP standards.

1. Major International API Manufacturers

a. Wuxi AppTec (China):
Provides a range of iodinated contrast agents, including custom synthesis offerings compliant with regulatory standards. Wuxi’s state-of-the-art facilities and extensive experience position it as a reliable source for bulk APIs related to contrast media.

b. Jiangsu Hengrui Medicine Co., Ltd. (China):
Known for producing specialty chemical intermediates and APIs used in radiocontrast agents. Their capacity to manufacture high-purity iodine derivatives aligns with industry needs for Iodoxamate Meglumine API production.

c. Sigma-Aldrich / MilliporeSigma (USA/Europe):
While primarily an excipient and reagent supplier, Sigma offers high-quality raw materials like iodine compounds and meglumine, which can be used by licensed manufacturers to synthesize APIs.

d. Beijing Shuangding Chemical Co., Ltd. (China):
-specialized in iodine and iodine derivatives, with a portfolio including intermediates for contrast agents. Their bulk iodine compounds meet pharmacopoeial standards.

e. Piramal Pharma Solutions (India):
Offers contract manufacturing including iodinated contrast agents and APIs, with facilities compliant with global Good Manufacturing Practices (GMP).

2. Regional/Niche Suppliers

Regional suppliers in India, China, and Europe serve as critical sources for precursor chemicals and intermediates. Examples include:

• Anhui Feichi Pharmaceutical Co., Ltd. (China)
• Huntsman Corporation (USA/Europe) for specialty chemicals involved in iodination processes

However, these sources often supply raw materials rather than finished APIs for direct pharmaceutical procurement.

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Regulatory and Quality Considerations

Ensuring API quality involves adhering to stringent standards, including USP, EP, and JP monographs, as well as compliance with FDA, EMA, and other regulatory bodies. Validated suppliers possessing current Drug Master Files (DMFs) or Certificates of Suitability (CEPs) are preferred.

Quality assurance measures focus on:

• Purity: >99% iodine content, low residual solvents.
• Traceability: Full batch documentation and compliance with ISO 9001 standards.
• Stability: API stability under various storage conditions.

Suppliers with validated manufacturing processes and robust quality control protocols reduce regulatory risks and ensure reliable supply chains.

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Strategic Sourcing and Supply Chain Risks

The global sourcing landscape for API production for Iodoxamate Meglumine is prone to:

• Geopolitical disruptions, especially in regions where manufacturing concentrations occur.
• Raw material scarcity, particularly with elemental iodine, affecting global supply.
• Regulatory shifts, impacting registration and manufacturing approvals in key markets.

To mitigate risks, pharmaceutical companies often adopt dual sourcing strategies, working with primary and secondary suppliers, maintaining safety stock, and engaging in long-term supplier agreements.

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Emerging Trends and Future Outlook

Innovation in iodinated contrast agent APIs aims to improve manufacturing efficiency and reduce reliance on supply chains susceptible to geopolitical issues. Biotechnological advances and process optimizations may lead to alternative synthesis routes, reducing dependency on elemental iodine sources.

Additionally, increasing regulatory harmonization and supply chain transparency are expected to bolster supplier credibility, supporting safe and uninterrupted access to high-quality APIs for Iodoxamate Meglumine.

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Conclusion

The procurement of bulk API sources for Iodoxamate Meglumine relies on a network of established global suppliers specializing in high-purity iodine derivatives, meglumine, and intermediates. Pharmaceutical companies must prioritize suppliers with proven quality records, regulatory compliance, and supply stability. Strategic sourcing, combined with ongoing industry innovations, will be vital to maintaining reliable supply chains amidst evolving regulatory and geopolitical landscapes.

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Key Takeaways

• High-quality supply chains for iodine derivatives and meglumine are critical for manufacturing Iodoxamate Meglumine APIs.
• Major suppliers include Chinese firms like Wuxi AppTec and Jiangsu Hengrui Medicine, along with Indian and Western contract manufacturers.
• Regulatory compliance (FDA, EMA, USP) and quality certification underpin supplier selection.
• Supply chain risks necessitate diversification, safety stock, and long-term supplier relationships.
• Emerging manufacturing innovations aim to enhance sustainability and resilience in API production.

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FAQs

1. What are the primary raw materials used in manufacturing Iodoxamate Meglumine API?
The core raw materials include elemental iodine or iodine derivatives and meglumine (N-methyl-D-glucamine). These compounds are processed through iodination and conjugation steps to produce the final API.

2. Which countries dominate the supply of iodine derivatives used in Iodoxamate Meglumine?
China and India are leading suppliers of iodine chemicals and intermediates, supported by a growing number of regional manufacturers.

3. How critical is regulatory compliance when sourcing API ingredients for Iodoxamate Meglumine?
Regulatory compliance is essential; suppliers must adhere to GMP standards and have certifications such as DMFs or CEPs to ensure quality, safety, and acceptability in global markets.

4. What are the main risks associated with API sourcing for contrast agents?
Risks include geopolitical instability, raw material shortages, regulatory hurdles, and supply chain disruptions, which can affect API availability and manufacturing timelines.

5. How are emerging trends impacting the API supply chain for contrast agents?
Innovation in synthesis processes and process optimization aims to improve efficiency, reduce costs, and lessen dependence on vulnerable supply chains, strengthening the resilience of API production.

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References:

[1] International Pharmacopoeia, USP, and EP monographs for iodine compounds and meglumine.
[2] Industry reports on global iodinated contrast media production and supply chain trends.
[3] Manufacturer disclosures and certifications from primary API suppliers.