Bulk Pharmaceutical API Sources for OPTIRAY 350

Bulk Pharmaceutical API Sources for OPTIRAY 350

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 350

Last updated: August 5, 2025

Introduction

Optiray 350, a diagnostic contrast agent used in medical imaging procedures such as computed tomography (CT) scans, contains iohexol as its active pharmaceutical ingredient (API). The integrity, safety, and compliance of the API supply chain directly impact the consistent quality and efficacy of the final pharmaceutical product. As the demand for contrast agents like Optiray 350 rises globally, identifying reliable, high-volume sources of its API—iohexol—is critical for manufacturers, distributors, and healthcare providers.

This article comprehensively explores the primary bulk sources of iohexol, focusing specifically on those capable of supplying the quantities necessary for manufacturing Optiray 350. It covers key manufacturers, their capacities, compliance standards, and strategic considerations for sourcing.

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Understanding Iohexol as the API in Optiray 350

Iohexol belongs to the class of non-ionic, water-soluble contrast media. Its molecular formula is C19H26I3N3O9, and it is characterized by high iodine content, which enables effective radiopacity. The API’s purity, sterility, and consistent quality are crucial for patient safety and imaging performance.

The global market for iohexol is dominated by a few large pharmaceutical manufacturers with extensive API production capabilities. The following sections examine these key sources.

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Major Bulk Sources of Iohexol for Optiray 350

1. GE Healthcare (GE Healthcare Life Sciences)

Overview:
GE Healthcare is a dominant player in the contrast media market, with established API manufacturing facilities that produce iohexol at high volumes for global distribution.

API Production Capacity & Compliance:
GE Healthcare’s manufacturing facilities include cGMP-certified plants that meet stringent regulatory standards such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other international bodies. The company invests heavily in quality assurance, ensuring batch-to-batch consistency, high purity, and sterile processes suitable for injectables.

Strategic Importance:
As the originator of many contrast agents, GE Healthcare maintains control of its supply chain, which enables consistent availability of iohexol APIs for both proprietary and third-party formulations like Optiray 350. Their global distribution channels facilitate efficient supply to markets worldwide.

2. Guerbet

Overview:
Guerbet is a French pharmaceutical company specializing in contrast agents with a robust API production segment offering high-grade iohexol for global markets.

API Production Capacity & Compliance:
Guerbet’s facilities are certified under Good Manufacturing Practice (GMP) standards, ensuring the API’s safety and purity. The company emphasizes quality control, with ongoing investments in refining manufacturing processes to meet evolving regulatory demands.

Supply Reliability:
Guerbet’s strategic focus on API quality and scalable production capacity make them a dependable source for bulk iohexol, especially for manufacturers seeking integrated supply options for diagnostic imaging agents.

3. Bracco Imaging

Overview:
An Italian multinational known for diagnostic imaging solutions, Bracco produces its own API, including iohexol, for use in its contrast media portfolio.

API Production Capacity & Compliance:
Bracco's API manufacturing facilities operate under strict GMP guidelines and hold various certifications, including FDA approval for their API manufacturing processes. Their vertically integrated operations ensure tight control over API quality and supply stability.

Market Position:
Bracco’s extensive R&D and manufacturing infrastructure allow for large-scale production of iohexol APIs, making them a prominent source for bulk supplies, particularly for European and North American markets.

4. Zydus Cadila

Overview:
Indian pharmaceutical giant Zydus Cadila has expanded its API manufacturing capabilities, including for iohexol. The company aims to meet growing global demand by scaling up production.

API Production Capacity & Compliance:
Zydus maintains GMP-certified manufacturing units with capacity to produce high-quality iohexol at scale. The company has gained international certifications, including approval from the US FDA and EMA, underscoring its commitment to quality.

Strategic Consideration:
Zydus’s competitive pricing and increasing regulatory approvals position it as an attractive sourcing partner for OEMs and generic manufacturers of contrast agents like Optiray 350.

5. Other Notable API Manufacturers

While the aforementioned companies constitute the primary bulk sources, other regional manufacturers in countries such as China and South Korea are emerging as potential suppliers. These entities often offer competitive pricing but require rigorous quality validation to meet international standards. Suppliers like Lee's Pharmaceutical and CJ CheilJedang have reported capacities for iohexol production, albeit with varying certification profiles.

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Criteria for Selecting an API Supplier

Potential buyers should evaluate key factors when sourcing iohexol for Optiray 350:

• Regulatory Compliance: Suppliers must hold recent GMP certifications and approvals for the markets where the final product will be distributed.
• Production Capacity: Adequate scale to meet current and future demand, with flexibility for volume fluctuations.
• Quality Assurance: High purity levels, consistent batch quality, and validated sterilization processes.
• Supply Chain Reliability: Proven track record of on-time deliveries and contingency plans.
• Cost Efficiency: Competitive pricing, considering long-term contractual agreements to ensure price stability.

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Global Supply Chain Dynamics and Risks

The concentrated nature of iohexol production sources implies inherent risks, including supply disruptions due to regulatory issues, manufacturing delays, or geopolitical factors. Recent trends toward regional diversification and establishing multiple supply lines mitigate risks for pharmaceutical companies. Ensuring proper validation and quality control when engaging with new suppliers is critical.

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Strategic Recommendations

• Develop Multi-supplier Relationships: Diversify sources across established manufacturers to reduce dependency.
• Focus on Regulatory Compliance: Prioritize suppliers with proven GMP certification and robust quality management systems.
• Conduct Due Diligence: Perform rigorous audits and quality assessments before onboarding new vendors.
• Engage in Long-term Contracts: Secure capacity through strategic agreements to prevent shortages.

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Conclusion

The supply of iohexol API for the production of Optiray 350 primarily hinges on a handful of global manufacturers—GE Healthcare, Guerbet, Bracco, and Zydus Cadila—each offering distinct advantages in capacity, compliance, and geographic coverage. Navigating this landscape requires careful assessment of regulatory status, quality assurance, and supply reliability to ensure uninterrupted production of high-caliber contrast agents.

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Key Takeaways

• The primary bulk sources for iohexol API include GE Healthcare, Guerbet, Bracco, and Zydus Cadila, each with extensive manufacturing capacity and regulatory approvals.
• Ensuring API sourcing from GMP-certified suppliers minimizes regulatory and quality risks.
• Diversifying supply sources reduces dependence on single vendors and mitigates potential supply chain disruptions.
• Long-term strategic procurement agreements enhance supply stability and cost management.
• Continuous monitoring of regional manufacturing capacity developments is vital to anticipate supply chain shifts.

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FAQs

1. What are the main regulatory considerations when sourcing iohexol API for Optiray 350?
API suppliers must hold GMP certifications from relevant authorities such as the FDA or EMA, ensuring quality, safety, and regulatory compliance for global markets.

2. How does the supply chain stability impact the production of Optiray 350?
Supply chain stability is critical to maintain consistent manufacturing schedules, prevent shortages, and ensure timely delivery of high-quality contrast agents.

3. Are there regional differences in iohexol API quality standards?
Yes; while GMP standards are internationally recognized, variations exist based on regional regulations. Verification through audits and certifications ensures compliance regardless of origin.

4. Can regional manufacturers supply iohexol at scale comparable to global players?
Emerging regional manufacturers are increasing capacities, but global players generally offer more extensive, proven production pipelines suitable for large-volume needs.

5. What are potential risks associated with sourcing iohexol from multiple suppliers?
Risks include variability in quality, delays during validation, and logistical complexities; rigorous vetting and quality assurance are essential to mitigating these risks.

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References

[1] "Iohexol," U.S. Food & Drug Administration, FDA, 2022.
[2] "Contrast Agents Market Overview," GlobalData Healthcare Reports, 2023.
[3] "GMP Certification Standards," International Conference on Harmonisation (ICH), 2021.
[4] "Pharmaceutical API Manufacturing in India," Indian Pharmaceutical Alliance, 2022.