Bulk Pharmaceutical API Sources for CONRAY 400

Bulk Pharmaceutical API Sources for CONRAY 400

Vendor	Vendor Homepage	Vendor Sku	API Url
BOC Sciences		1225-20-3
MuseChem		M048406
Clearsynth		CS-P-01051

Bulk Active Pharmaceutical Ingredient (API) Sources for: CONRAY 400

Last updated: August 7, 2025

Introduction

Conray 400 is a radiographic contrast agent primarily utilized in diagnostic imaging procedures to enhance the visibility of internal structures during X-ray examinations. Its active pharmaceutical ingredient (API), ioversol, is a nonionic, iodinated contrast medium renowned for its high safety profile and efficacy. The supply chain for Ioversol — specifically, bulk APIs — is critical for pharmaceutical manufacturers aiming to produce Conray 400 at scale. This article provides an in-depth analysis of primary sources, key suppliers, and supply chain considerations for sourcing API for Conray 400, equipping industry stakeholders with essential intelligence for procurement and strategic planning.

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Understanding the API: Ioversol

Ioversol is a nonionic, water-soluble iodinated contrast agent used extensively in diagnostic radiology. Its molecular structure confers high iodine content, facilitating X-ray attenuation, which enhances imaging of blood vessels, tissues, and organs. The API's quality, safety, and supply chain integrity are paramount, given the product's critical role in medical diagnostics.

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Major API Suppliers for Ioversol (Conray 400)

The global market for ioversol API is dominated by a handful of pharmaceutical and chemical manufacturing giants. These manufacturers adhere to strict regulatory standards such as cGMP (current Good Manufacturing Practice) and ISO certifications, ensuring consistent quality aligned with pharmaceutical requirements.

1. Bayer AG

Overview
Bayer is a leading global life sciences company with a significant footprint in radiology contrast agents. Its portfolio includes manufacturing and supplying ioversol API for proprietary formulations like Conray 400.

Supply Capabilities
Bayer Research and Development (R&D) facilities located in Germany and the United States produce high-quality ioversol API. The company maintains a robust global distribution network, ensuring timely supply for pharmaceutical manufacturers.

Compliance & Certifications
Bayer complies with international standards, including USP and EP monographs, and maintains GMP certifications for its API production facilities.

2. Lunan Pharmaceutical Group

Overview
Headquartered in China, Lunan Pharmaceutical Group is an emerging leader in the production of iodinated contrast agents and APIs.

API Production
Lunan produces bulk ioversol API primarily for regional markets but increasingly for global export. Their facilities are cGMP-certified, and the company invests heavily in quality assurance and process validation.

Market Position and Reliability
While historically focused on regional markets, Lunan now seeks to expand into Western markets, aligning their API quality with international standards for broader acceptance.

3. Hangzhou Sunhope Pharmaceutical Co., Ltd.

Overview
This Chinese pharmaceutical manufacturer specializes in iodinated contrast media and their APIs. They have a growing reputation for supplying high-purity APIs for international pharmaceutical companies.

API Quality Profile
Their manufacturing practices conform to cGMP standards, and they hold multiple international certifications, including ISO 9001 and 13485, underscoring their commitment to quality.

4. Shandong Sinphar Pharmaceutical Co., Ltd.

Overview
A notable Chinese API producer, Sinphar manufactures ioversol API with a focus on ensuring high purity levels suitable for injectable formulations.

Supply Model
They supply bulk API to both domestic markets and international OEMs (original equipment manufacturers). Their production facilities are certified by relevant regulatory agencies, including the China Food and Drug Administration (CFDA).

5. National Suppliers and Future Entrants

While Bayer remains the dominant global supplier, several other regional or niche manufacturers are emerging, particularly in India and Southeast Asia, fueled by rising demand for contrast media. Companies like Serum Institute of India are exploring API production, yet their capacity for high-purity, clinical-grade API compatible with Conray 400 remains under development or regulatory approval.

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Supply Chain Considerations

• Regulatory Compliance: Sourcing API for injectable contrast agents mandates strict adherence to GMP and pharmaceutical standards. Only suppliers with appropriate certifications (e.g., FDA, EMA, China NMPA, or European Pharmacopoeia) qualify for global distribution.

• Manufacturing Capacity and Flexibility: For large-scale production, securing API from suppliers with proven manufacturing capacity and cost-effective logistics is crucial. Bayer's established infrastructure remains unmatched, but regional manufacturers may offer competitive advantages.

• Quality Assurance & Traceability: Ensuring API quality involves comprehensive certifications, batch testing results, and traceability documentation. Reputable suppliers provide detailed Certificates of Analysis (CoA) and regulatory documentation to support GMP compliance.

• Geopolitical and Trade Risks: Geopolitical stability, trade restrictions, and tariffs impact supply routes from certain regions, especially China. Diversification of sources mitigates supply chain disruptions.

• Pricing Dynamics: API costs depend on scale, purity, regulatory compliance, and the manufacturing location. Bayer’s premium pricing reflects its stringent quality standards; regional suppliers may offer cost advantages but require thorough vetting.

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Strategic Recommendations for API Sourcing

• Prioritize Tier-1 Suppliers: Engage with certified, reputable manufacturers such as Bayer to ensure supply security and quality compliance.

• Develop Regional Partnerships: Establish relationships with Chinese API producers like Lunan Pharmaceutical and Sunhope to diversify sourcing options and manage costs effectively.

• Implement Rigorous Qualification Processes: Conduct comprehensive audits, verify certification validity, and perform sample testing before onboarding new suppliers.

• Monitor Regulatory Changes: Stay informed about evolving regulations that impact API approval and import/export restrictions, especially in emerging markets.

• Invest in Supply Chain Resilience: Maintain multiple supplier relationships and consider stockpiling API batches to buffer against potential disruptions.

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Conclusion

The procurement landscape for the API of Conray 400, ioversol, is characterized by a handful of globally recognized manufacturers and regional producers. Bayer AG remains the premier source for high-purity API, supported by its long-standing reputation and extensive manufacturing network. However, increasing advancements among Chinese API producers like Lunan and Sunhope provide additional strategic avenues, especially considering regional cost benefits and supply diversification. Ensuring regulatory compliance, verifying quality, and establishing resilient supply chains are essential for pharmaceutical companies committed to delivering consistent, safe, and effective Conray 400 formulations.

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Key Takeaways

• Bayer AG remains the leading and most reliable global supplier of ioversol API for Conray 400, adhering to international standards.

• Chinese manufacturers such as Lunan Pharmaceutical and Sunhope are emerging as credible sources, offering competitive pricing and expanding capacity.

• Regulatory compliance, quality certification, and traceability are non-negotiable when selecting API suppliers for injectable contrast agents.

• Supply chain diversification mitigates risks associated with geopolitical shifts, trade restrictions, and manufacturing disruptions.

• Establishing strong supplier qualification processes and maintaining flexible sourcing strategies are essential for ensuring uninterrupted production.

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FAQs

1. What are the primary regulatory considerations when sourcing API for Conray 400?
Manufacturers must ensure suppliers comply with cGMP standards and possess certifications such as FDA approval, EMA certification, or equivalent regional authorizations. Additionally, Certificates of Analysis and batch traceability are mandatory for regulatory submissions.

2. Can regional Chinese API producers supply high-quality ioversol suitable for international markets?
Yes; reputable Chinese manufacturers like Lunan Pharmaceutical and Sunhope have achieved certifications aligning with international standards, making their APIs suitable for global distribution. However, due diligence and rigorous quality verification are essential.

3. How does supply chain diversification impact costs for API sourcing?
Diversification can introduce cost variances; regional suppliers may offer lower prices but could pose regulatory or logistical challenges. Balancing cost with quality and regulatory compliance is critical for optimal sourcing strategies.

4. Are there alternatives to Bayer for API procurement in the case of supply shortages?
Regional producers such as Lunan and Sunhope can serve as credible alternatives, provided they meet the necessary quality and regulatory standards. Engaging multiple suppliers reduces dependency on a single source.

5. What role does intellectual property play in sourcing pharmaceuticals APIs?
Most APIs like ioversol are produced under strict licensing and licensing agreements. Securing APIs from authorized and licensed suppliers ensures compliance and minimizes IP infringement risks.

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Sources

[1] Bayer AG Official Website, Pharmaceutical API Portfolio, 2023.
[2] Chinese API Manufacturers Association, Industry Standards & Certifications, 2022.
[3] European Pharmacopoeia, Monograph on Ioversol, 2021.
[4] U.S. Food and Drug Administration, API Registration & Compliance Guidelines, 2022.
[5] Industry Reports on the Global Contrast Media Market, MarketWatch, 2023.