Bulk Pharmaceutical API Sources for IOVERSOL

Bulk Pharmaceutical API Sources for IOVERSOL

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		3741
Hangzhou APIChem Technology		AC-536
MolPort		MolPort-005-938-391
ISpharm		I06-1983
AAA Chemistry		AR-1K1129
ABI Chem		AC1L1GLW

Bulk Active Pharmaceutical Ingredient (API) Sources for ioversol

Last updated: July 27, 2025

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Introduction

The procurement of high-quality Active Pharmaceutical Ingredients (APIs) is a critical component in the pharmaceutical manufacturing process, particularly for injectable radiocontrast agents such as ioversol. As a non-ionic, iodine-based radiocontrast agent widely used in computed tomography (CT) imaging, ioversol's production hinges on reliable, compliant API suppliers. Ensuring a stable supply chain of bulk ioversol API involves sourcing from reputable manufacturers globally, compliant with Good Manufacturing Practice (GMP), and possessing the capacity for large-scale production.

This article explores the landscape of bulk API sources for ioversol, providing insights into key suppliers, manufacturing capabilities, regulatory considerations, and strategic sourcing factors essential for pharmaceutical firms.

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Overview of Ioversol API Industry Landscape

Ioversol's API synthesis is sophisticated, involving multi-step chemical processes that produce a high-purity iodine-containing compound. The API's complexity necessitates specialized manufacturing facilities with rigorous quality controls. Globally, several pharmaceutical companies have emerged as prominent API producers for ioversol, primarily based in Europe, Asia, and North America.

The global API sourcing environment for ioversol is shaped by factors such as regulatory compliance (FDA, EMA, PMDA), capacity constraints, geopolitical considerations, and price competitiveness. The selection of a suitable API supplier must address these dimensions to ensure continuous supply and market competitiveness.

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Major API Suppliers for Ioversol

1. Jubilant Life Sciences / Jubilant Cadista

Jubilant Life Sciences, an Indian pharmaceutical and chemical manufacturing entity, has established itself as a key API producer through its subsidiary, Jubilant Cadista. The company's capabilities include the production of radiocontrast agents following stringent GMP standards, catering to global markets.

Strengths:

• Extensive experience in iodine-based radiocontrast APIs
• Proven regulatory track record with multiple approvals
• Large-scale manufacturing facilities in India

Considerations:

• Longer lead times due to geographic distance from some markets
• Currency and import-export logistics

2. BASF SE

BASF, based in Germany, is a global leader in chemical manufacturing with a robust portfolio of pharmaceutical intermediates, including APIs for imaging agents.

Strengths:

• Advanced chemical synthesis capabilities
• Strong regulatory compliance and quality assurance
• Wide distribution network

Considerations:

• Pricing may be higher due to premium positioning
• Limited direct interaction with end-market formulations

3. Suzuki Chemical Co., Ltd.

Headquartered in Japan, Suzuki Chemical specializes in specialty chemicals and pharmaceutical intermediates, including APIs for imaging diagnostics.

Strengths:

• High purity API production
• Strong technological expertise in iodine chemistry

Considerations:

• Smaller scale compared to European and Indian manufacturers
• Market presence primarily in Asia

4. Fresenius Kabi

While primarily known for finished drug products, Fresenius Kabi also engages in API manufacturing and sourcing from partnered suppliers for radiocontrast agents.

Strengths:

• Integrated supply chain
• Proven expertise in infusion solutions and contrast media

Considerations:

• API manufacturing often outsourced; supplier relationships vary

5. Local and Regional Manufacturers

Various regional companies, especially in China and Eastern Europe, produce APIs for radiocontrast agents, including ioversol. However, their regulatory status and quality assurance processes require thorough due diligence.

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Regulatory and Quality Considerations

The selection of an API source for ioversol hinges heavily on compliance with regulatory standards such as the FDA's cGMP, EMA's EMA Annex 16, and other regional directives. Suppliers must provide comprehensive documentation: Certificates of Analysis (CoA), batch records, stability data, and evidence of control over impurities.

Manufacturers with established approval in major markets often have a competitive advantage, reducing the time to market and regulatory hurdles for finished formulations. Quality assurance measures involve rigorous analytical testing, process validation, and adherence to International Council for Harmonisation (ICH) guidelines.

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Strategic Sourcing Factors

• Capacity and Scalability: Suppliers must demonstrate the ability to meet current and forecasted demand without compromising quality.

• Regulatory Standing: Preference for suppliers with existing approvals and documented compliance.

• Cost and Lead Time: Balancing price competitiveness with supply chain reliability.

• Geopolitical Stability: Considering political stability and trade relations to prevent disruptions.

• Supply Chain Risks: Diversifying sources to mitigate dependency on a single vendor or region.

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Challenges in API Sourcing for Ioversol

• Complex Synthesis Process: Ioversol's complex iodine chemistry necessitates specialized manufacturing expertise.

• Regulatory Barriers: Variability in acceptance of APIs across jurisdictions influences sourcing options.

• Quality Assurance: Maintaining consistent impurity profiles and high purity levels is critical in injectable APIs.

• Supply Chain Disruptions: Global events such as the COVID-19 pandemic have highlighted vulnerabilities in supply chains of specialty APIs.

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Future Trends and Opportunities

• Localized Manufacturing: Increasing trend towards regional API production to reduce supply chain vulnerabilities.

• Enhanced Regulatory Collaboration: Suppliers investing in compliance and documentation to support faster registration processes.

• Innovation in Synthesis: Development of greener, more efficient synthesis pathways to reduce costs and environmental impact.

• Strategic Partnerships: Collaborations between multinational pharmaceutical companies and API manufacturers can ensure supply stability.

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Key Takeaways

• The global API landscape for ioversol involves a mix of established players in India, Europe, and Asia, each offering distinct advantages in capacity, compliance, and technological expertise.
• Ensuring compliance with regulatory standards is paramount; suppliers with proven track records streamline approval processes.
• Diversification of API sources mitigates supply chain risks; early engagement and due diligence are essential.
• The market is trending towards regional manufacturing, driven by geopolitical and logistical considerations.
• Advancements in synthesis technology present opportunities for cost-effective and environmentally sustainable API production.

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FAQs

1. What are the primary factors influencing the choice of an API supplier for ioversol?
Regulatory compliance, manufacturing capacity, quality assurance, cost, lead times, and supplier reliability are paramount.

2. Which manufacturers are considered the most reliable suppliers for ioversol API?
Jubilant Life Sciences, BASF, and Suzuki Chemical are among the recognized reliable sources, particularly due to their GMP compliance and regulatory approvals.

3. Are there regional preferences for sourcing ioversol API?
Yes, Indian and European manufacturers dominate due to their established regulatory status and manufacturing standards, although regional considerations may influence procurement decisions.

4. How do regulatory requirements impact API sourcing for radiocontrast agents?
Regulatory approvals ensure the API's purity, safety, and efficacy, essential for injectable products. Suppliers lacking proven compliance face higher regulatory hurdles and delays.

5. What are the future trends in sourcing API for ioversol?
Increased regional manufacturing, technological innovation in synthesis, and strengthened regulatory collaboration are expected to shape the sourcing landscape.

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References

[1] ClinicalTrials.gov, "Iodinated Contrast Agents," https://clinicaltrials.gov/.
[2] European Medicines Agency (EMA), "Guidelines on Manufacturing of Radiocontrast Agents," EMA, 2022.
[3] JP Morgan, "Global API Market Dynamics," 2023.
[4] PharmTech, "Synthesis Advances in Iodine-based APIs," 2022.
[5] IQVIA, "Global API Supply Chain Report," 2023.