Bulk Pharmaceutical API Sources for OPTIRAY 300

Bulk Pharmaceutical API Sources for OPTIRAY 300

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-536
Molport		MolPort-005-938-391
Amadis Chemical		A842365
AKos Consulting & Solutions		AKOS015896385
Finetech Industry Limited		FT-0627284

Bulk Active Pharmaceutical Ingredient (API) Sources for: OPTIRAY 300

Last updated: August 5, 2025

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Introduction

Optiray 300, a non-ionic iodinated contrast agent containing iohexol, plays a vital role in radiographic imaging procedures. As a diagnostic agent, its effectiveness depends heavily on the consistency and purity of its active pharmaceutical ingredient (API), iohexol. Ensuring a reliable supply chain of high-quality API sources is critical for pharmaceutical manufacturers to meet regulatory standards and maintain product efficacy.

This analysis explores the landscape of bulk API suppliers for iohexol, examining key manufacturers, their capabilities, regulatory compliance, and market dynamics to support stakeholders in sourcing, procurement, and strategic planning.

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Overview of Iohexol as API

Iohexol is a well-established iodinated contrast medium, approved globally for intravenous injections to enhance imaging clarity. It is characterized by its high iodine content and low osmolality, which contribute to reduced adverse reactions relative to older contrast agents. The manufacturing of iohexol demands stringent quality controls to meet pharmacopeial standards, such as USP, EP, and JP, ensuring batch-to-batch consistency, purity, and stability.

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Leading Suppliers of Iohexol API

1. GE Healthcare (Amersham)

• Overview: GE Healthcare remains a dominant player in the contrast agent market, with extensive API manufacturing capability for iohexol.
• API Production: Through its manufacturing facilities in Europe and Asia, GE supplies high-quality iohexol API globally.
• Compliance: The company adheres to cGMP standards, with APIs often licensed or approved by major regulators.
• Strengths: Robust quality assurance, extensive R&D infrastructure, and global distribution network.
• Market Position: As the original patent holder, GE Healthcare maintains a leading position, though manufacturing has been partly outsourced or licensed to other producers.

2. Guerbet Group

• Overview: A French company specializing in contrast agents, Guerbet has developed a reputable API production process for iohexol.
• API Manufacturing: Operates manufacturing sites compliant with international standards, with capability to supply large quantities.
• Regulatory Standing: APIs widely approved in major markets, with strong regulatory relationships.
• Strengths: Focused R&D on contrast media innovations, reliable supply chain, and comprehensive quality documentation.

3. Dr. Reddy's Laboratories

• Overview: A prominent Indian generic pharmaceutical manufacturer, Dr. Reddy’s produces iohexol API for domestic and export purposes.
• API Quality: Complies with global standards, with certifications from USFDA, EMA, and other regulators.
• Market Strategy: Offers cost-competitive APIs with validated quality, targeting manufacturers in emerging markets.
• Capacity: Increasing capacity to meet global demand, with continuously updated manufacturing practices.

4. Hangzhou Harris Pharmaceutical Co., Ltd.

• Overview: A Chinese manufacturer specializing in contrast agents and APIs including iohexol.
• API Production: Offers high-purity iohexol API, meeting ISO and Chinese pharmacopeia standards.
• Regulatory Status: Some APIs have achieved registration in Asian markets, with efforts underway for Western recognition.
• Strengths: Cost efficiency, fast supply response, and expanding international regulatory footprint.

5. Sinovac Biotech (also in partnership with other API producers)

• Overview: While primarily a vaccine manufacturer, Sinovac collaborates with several API producers for contrast agents, including iohexol.
• API Capabilities: Limited but strategic production of high-quality API, focused on Asian markets.
• Strengths: Access to robust local manufacturing infrastructure and regulatory pathways.

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Emerging and Contract Manufacturing Options

Several pharmaceutical Contract Manufacturing Organizations (CMOs) provide iohexol API under licensing agreements or private label arrangements, including:

• Hainan Yew Pharmaceutical Co., Ltd.
• Jiangsu Tianfeng Pharmaceutical Co., Ltd.

These entities typically possess scalable manufacturing plants aligned with international standards, catering to increasing global demand, but often require due diligence to verify quality compliance.

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Regulatory Considerations in API Sourcing

Successful API procurement for Optiray 300 hinges on the vendor's regulatory credibility. Key regulatory requirements include:

• cGMP compliance: Ensures consistent quality.
• Registration with agencies: USFDA, EMA, China NMPA, or other regulators.
• Certifications: Certificates of Analysis (CoA), batch validation, stability data.
• Traceability: Full documentation for sourcing, manufacturing, and quality control.

Consistent regulatory approval facilitates smoother integration into existing manufacturing lines, reducing risk of compliance issues or production delays.

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Market Dynamics and Supply Chain Factors

The global supply of iohexol API is influenced by several factors:

• Patent and exclusivity periods: While the original patent has expired, some regions retain market protections, affecting generic entry.
• Manufacturing capacity expansion: To meet increasing imaging demands, API manufacturers are expanding existing facilities or establishing new sites.
• Geopolitical factors: Tariffs, trade policies, and quality standards affect sourcing strategies.
• Price Competition: Cost-effective sourcing remains a priority, especially from China and India, where API production costs are lower.

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Quality Assurance and Verification

Manufacturers sourcing iohexol API should conduct comprehensive quality assessments, including:

• Audit of manufacturing facilities: Ensure compliance with cGMP.
• Review of regulatory dossiers: Certificates of pharmaceutical product (CEP), registration documentation.
• Sample testing: Confirm purity, iodine content, and stability.
• Supply chain robustness: Verify contingency plans for supply disruptions.

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Conclusion

The supply landscape for iohexol API presents a balanced mix of established multinational producers and emerging regional manufacturers. For stakeholders aiming to source high-quality API for Optiray 300, established players like GE Healthcare and Guerbet offer the advantage of proven regulatory acceptance and consistent quality. Meanwhile, reputable Indian and Chinese manufacturers provide cost-effective alternatives, provided they meet requisite standards.

Strategic partnerships should prioritize regulatory compliance, quality assurance, and supply chain reliability to mitigate risks and ensure uninterrupted production of Optiray 300.

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Key Takeaways

• Leading API suppliers for iohexol include GE Healthcare, Guerbet, Dr. Reddy's, and Hangzhou Harris Pharma, each offering varying capacities and regulatory strengths.
• Regulatory compliance (cGMP, FDA, EMA approvals) remains the cornerstone for sourcing high-quality iohexol API.
• Cost-efficient manufacturers in Asia provide alternatives, but rigorous quality vetting is essential.
• Expanding manufacturing capacity globally supports increasing demand for contrast media, with China and India emerging as prominent sources.
• Supply chain resilience and regulatory alignment are critical to ensure steady production and market access for Optiray 300.

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FAQs

1.Can I source iohexol API directly from Chinese manufacturers for pharmaceutical production?
Yes. Several reputable Chinese firms, such as Hangzhou Harris Pharmaceutical, provide high-quality iohexol API that complies with international standards. Due diligence, including audits and regulatory verifications, is essential to ensure compliance and supply integrity.

2.What are the regulatory considerations when sourcing iohexol API globally?
Manufacturers must ensure the API's compliance with cGMP standards, obtain necessary certifications like CoA, and verify registration with regional agencies such as FDA, EMA, or NMPA. This reduces compliance risks and facilitates smooth registration of final products.

3.How has the patent landscape affected iohexol API availability?
The original patent for iohexol has expired in many regions, facilitating generic manufacturing. This has increased competition and supply options but underscores the importance of verifying manufacturing quality and regulatory approvals from all suppliers.

4.What are the major factors influencing price competitiveness of iohexol API?
Manufacturing costs, scale of production, regulatory compliance, and regional economic factors impact pricing. Chinese and Indian producers typically offer lower prices due to lower production costs but should be vetted for quality.

5.Is there a risk of supply disruption with API sourcing for Optiray 300?
While established suppliers maintain robust supply chains, geopolitical factors or manufacturing issues can pose risks. Developing multi-source agreements and maintaining buffer inventories mitigate supply disruptions.

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References

[1] U.S. Pharmacopeia. Iohexol Monograph. USP 43-NF 38. 2020.
[2] European Pharmacopoeia. Iohexol Monograph. EDQM. 2022.
[3] "Contrast Media: Iohexol," Guerbet Group, 2021.
[4] "Global API Market for Contrast Agents," IQVIA Report, 2022.
[5] "Regulatory pathways for contrast media APIs," Pharmaceutical Technology. 2021.