Bulk Pharmaceutical API Sources for CYSTOGRAFIN DILUTE

Bulk Pharmaceutical API Sources for CYSTOGRAFIN DILUTE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M5266_SIGMA
Molport		MolPort-003-958-766
MuseChem		M068508
BOC Sciences		131-49-7
THE BioTek		bt-267593
Smolecule		S525882

Bulk Active Pharmaceutical Ingredient (API) Sources for CYSTOGRAFIN DILUTE

Last updated: August 3, 2025

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Introduction

Cystografin Dilute, a contrast agent used in urography and cystography, relies on the active pharmaceutical ingredient (API) iohexol, an iodinated nonionic contrast agent. Ensuring a reliable supply of high-quality API sources is essential for manufacturers to produce Cystografin Dilute, maintaining safety, efficacy, and regulatory compliance. This analysis evaluates current API sourcing options, explores manufacturing challenges, and provides insights into strategic procurement for pharmaceutical companies.

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Understanding Cystografin Dilute and Its API

Cystografin Dilute primarily comprises iohexol, a nonionic, water-soluble radiocontrast agent characterized by its high iodine content for imaging efficacy. Iohexol's chemical formula is C19H26I3N3O9, and it is produced through sophisticated synthetic pathways involving iodination and polyol chemistry, necessitating precision manufacturing.

While the name "Cystografin Dilute" refers to a diluted formulation, its legacies are rooted in the API iohexol. Historically, the API has been supplied by prominent pharmaceutical manufacturers with established production capabilities in Europe, the United States, and Asia.

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Major API Suppliers for Iohexol

1. GE Healthcare (formerly Amersham International)

• Overview: GE Healthcare remains a leading producer of iohexol API, leveraging decades of experience in contrast media. Their manufacturing facilities comply with Good Manufacturing Practice (GMP) standards, ensuring high purity and consistent quality.
• Strengths: Tight quality control, extensive regulatory experience, broad distribution network.
• Considerations: Often the supplier of choice for branded formulations with robust supply chains.

2. Bracco Imaging

• Overview: As a key player in contrast media, Bracco supplies both API and finished contrast agents, including iohexol.
• Strengths: Vertical integration from API to finished product, strong R&D for customized needs.
• Considerations: May offer competitive pricing based on long-standing production facilities.

3. Guerbet Group

• Overview: A distinguished global company specializing in contrast media, Guerbet manufactures iohexol API for internal use and licensing.
• Strengths: High regulatory standards, extensive quality assurance, strategic partnerships.
• Considerations: Focused on Asia and Europe markets; potential for supply diversification.

4. Jiangsu Hengrui Medicine Co., Ltd. (China)

• Overview: Chinese pharmaceutical manufacturers like Jiangsu Hengrui have expanded into contrast agent APIs.
• Strengths: Cost competitiveness, increasing GMP compliance, expanding export capabilities.
• Considerations: Regulatory hurdles, variance in quality standards compared to Western manufacturers.

5. Shenzhen Bright Pharmaceutical Co., Ltd.

• Overview: An emerging Chinese API producer, offering iohexol with updated manufacturing standards.
• Strengths: Price point advantages, aggressive export strategies.
• Considerations: Supply reliability and regulatory recognition may vary.

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Emerging and Alternative API Sources

6. Sino Biopharmaceutical Limited

• Overview: Engaged in contrast media production, including iohexol API.
• Strengths: Strong local presence and growing international export footprint.
• Considerations: Still developing global regulatory acceptance.

7. Contract Manufacturing Organizations (CMOs)

• Several Asian-CMO facilities offer iohexol API under contract manufacturing agreements. These provide flexible sourcing solutions but require rigorous qualification and audit processes to ensure compliance.

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Supply Chain and Quality Considerations

• Regulatory Compliance: Ensuring that API suppliers hold current WHO-GMP, EMA, or FDA approvals is critical. Non-compliance risks include product recalls and regulatory sanctions.
• Quality Assurance: Consistent API batch quality, high purity (over 99%), and traceability are non-negotiable standards.
• Capacity and Reliability: Suppliers must demonstrate supply stability aligned with manufacturing demands, avoiding shortages that can disrupt production.
• Cost Factors: Pricing varies significantly based on geography, scale, and regulatory standards. Cost advantages must not compromise quality.

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Geopolitical Factors and Supply Diversification

Dependence on a single supplier or region increases supply chain vulnerability. The COVID-19 pandemic underscored the importance of diversification to mitigate risks such as geopolitical tensions, trade restrictions, and regional disruptions.

Pharmaceutical companies are advised to establish multi-source agreements, maintain safety stocks, and evaluate supplier credentials regularly.

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Regulatory Landscape Impact

APIs for pharmaceutical products are subject to stringent regulations. Sourcing from approved manufacturers reduces validation efforts during audits, expedites regulatory filings, and facilitates market approval.

Global agencies like the EMA and FDA scrutinize API manufacturing facilities before approval. Suppliers with recent regulatory inspections and accepted audit reports are preferable.

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Strategic Sourcing Recommendations

• Prioritize Suppliers with Global Regulatory Experience: Partnerships with companies like GE Healthcare and Bracco can streamline regulatory pathways.
• Conduct Due Diligence: Incorporate rigorous audits, quality assessments, and supply chain evaluations.
• Negotiate Long-Term Supply Agreements: Secure favorable commercial terms and priority access.
• Invest in Quality Agreements: Clearly define quality, documentation, and traceability standards.
• Monitor Market Dynamics: Stay attuned to emerging manufacturers and regulatory changes impacting supply.

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Conclusion

The procurement of iohexol API for Cystografin Dilute requires a strategic approach to sourcing, emphasizing quality, regulatory compliance, supply reliability, and cost-efficiency. Established suppliers like GE Healthcare and Bracco offer high assurance but may come with premium costs. Emerging Asian manufacturers present competitive alternatives but necessitate thorough qualification. Diversification, ongoing supplier assessments, and adherence to regulatory standards remain paramount to sustaining a resilient supply chain.

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Key Takeaways

• Prioritize accredited, GMP-compliant API suppliers such as GE Healthcare, Bracco, and Guerbet to ensure quality and regulatory compliance.
• Diversify sources to mitigate regional and supply chain risks, especially considering geopolitical influences.
• Conduct systematic supplier qualification, including audits and validation to maintain high standards.
• Maintain strategic inventories to buffer against potential supply disruptions.
• Stay proactive with regulatory developments to streamline approvals and market access.

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FAQs

1. What are the primary chemical requirements for iohexol API used in Cystografin Dilute?
The API must possess high iodine content (>50%), purity (exceeding 99%), and stability. It must meet pharmacopeial standards (such as USP or Ph. Eur.) and comply with GMP regulations to ensure safety and efficacy.

2. How can a manufacturer verify the compliance of an API supplier?
Verification involves reviewing current GMP certificates, conducting on-site audits, examining batch records, and evaluating regulatory inspection reports from authorities like the FDA or EMA.

3. Are Chinese API manufacturers a viable alternative for sourcing iohexol?
Yes, several Chinese manufacturers have obtained GMP approval and offer competitive pricing. However, thorough validation and regulatory approval are required to mitigate risks related to quality and compliance.

4. What are the risks associated with single-source API procurement?
Reliance on a single supplier exposes companies to supply shortages, quality issues, regulatory setbacks, and geopolitical risks, which can impact production and market supply.

5. How does supply chain diversification improve resilience?
Diversification enables companies to mitigate disruptions by sourcing from multiple approved manufacturers across regions, ensuring continuous production and reducing dependency on any single supply source.

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Sources

1. [1] GE Healthcare Iohexol Product Information, GE Healthcare.
2. [2] Bracco Imaging: Technical Data Sheet on Iohexol.
3. [3] Guerbet Group: Contrast Media Manufacturing Standards.
4. [4] WHO Guidelines on Pharmaceutical Quality Assurance.
5. [5] Regulatory Inspection Reports (FDA, EMA).