Bulk Pharmaceutical API Sources for OMNIPAQUE 180

Bulk Pharmaceutical API Sources for OMNIPAQUE 180

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		D2158_SIGMA
Molport		MolPort-003-931-371
Hangzhou APIChem Technology		AC-1934
Amadis Chemical		A835339
AKos Consulting & Solutions		AKOS015895399
Finetech Industry Limited		FT-0627276
AbaChemScene		CS-2811

Bulk Active Pharmaceutical Ingredient (API) Sources for OMNIPAQUE 180

Last updated: July 31, 2025

Introduction

OMNIPAQUE 180 (iohexol injection) is a non-ionic, water-soluble iodinated contrast agent widely utilized in diagnostic imaging, particularly in computed tomography (CT) scans. As a critical component in the formulation, the availability and sourcing of high-quality Active Pharmaceutical Ingredient (API) for OMNIPAQUE 180 is fundamental to ensuring consistent product quality, regulatory compliance, and supply chain resilience. This report explores the primary and emerging sources for the bulk API of OMNIPAQUE 180, analyzing their advantages, limitations, and strategic considerations for pharmaceutical manufacturers.

Overview of Iohexol API Production

Iohexol API synthesis involves complex chemical steps, notably the multi-stage iodination of organic compounds to produce high-purity iodinated heterocyclic molecules. The manufacturing process demands stringent control over reaction conditions, purity levels (typically exceeding 99%), and impurity profiles to satisfy regulatory standards such as the U.S. FDA, EMA, and other global agencies.

Top API synthesis companies invest heavily in research and development, adhering to Good Manufacturing Practice (GMP), and maintain robust supply chains. The API market for iohexol is concentrated among few key players, with some producing APIs directly tailored for large multinational pharmaceutical companies, and others supplying via contract manufacturing arrangements.

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Leading API Suppliers for OMNIPAQUE 180

1. GE Healthcare (A Part of Cytiva)

Overview: Historically, GE Healthcare has been the primary manufacturer of OMNIPAQUE, including the API of iohexol. The company's vertical integration ensures control over the entire supply chain, from API synthesis to finished product manufacturing.

API Supply Details:

• Geographically concentrated in facilities based in the United States and Europe.
• API production adheres to stringent GMP standards, ensuring high purity and consistent quality.
• The company's API is used exclusively for their own finished products; however, through strategic partnerships, it may supply the API to approved third-party manufacturers under strict licensing agreements.

Advantages:

• Proven track record for quality and regulatory compliance.
• Established supply chains for global distribution.
• Integrated control ensures minimal variability.

Limitations:

• Limited API supply flexibility due to vertical integration.
• Higher production costs, which may influence pricing for third-party buyers.

2. Pentax (A Contract Manufacturer & Supplier)

Overview: Pentax, a Japanese pharmaceutical company, specializes in synthesizing and supplying high-purity APIs, including iodinated contrast agents like iohexol.

API Production Capabilities:

• GMP-certified manufacturing plants in Japan and China.
• Focused on high-volume, high-quality API production customized for regional and global markets.

Market Position:

• Supplies iohexol API to multiple generic and branded formulations.
• Works with licensed pharmaceutical companies, providing a competitive advantage in cost and reliability.

Advantages:

• Cost-effective sourcing options.
• Proven quality control processes.
• Flexibility for large-scale procurement.

Limitations:

• Limited worldwide brand recognition for raw API.
• Dependence on regional logistics and export controls.

3. WuXi AppTec

Overview: As a leading Contract Development and Manufacturing Organization (CDMO), WuXi AppTec offers API synthesis services, including iodinated contrast agents.

API Capabilities:

• GMP-certified manufacturing for APIs used in diagnostic imaging.
• Custom synthesis and scale-up solutions tailored to client specifications.

Market Position:

• Supplies API for multiple OEMs and generics companies.
• Rapid scale-up capabilities and robust quality assurance systems.

Advantages:

• Flexibility in production scale and customization.
• Extensive global manufacturing footprint.

Limitations:

• Not a brand owner; only supplies as a contract manufacturer.
• Potential variability based on client demand and project scope.

4. Zhejiang Hisun Pharmaceutical Co., Ltd.

Overview: Chinese-based pharmaceutical manufacturer with a focus on iodinated contrast agents.

API Production:

• Large-scale manufacturing facilities adhering to international GMP standards.
• Competitive pricing and reliable supply for regional markets.

Advantages:

• Cost advantages in API production.
• Established export channels in Asia, expanding globally.

Limitations:

• Regulatory hurdles in some markets.
• Variability in quality standards compared to Western GMP facilities; however, many Chinese producers are now certified to international standards.

5. Contract Manufacturing & Emerging Suppliers

Several smaller and emerging API manufacturers in India, South Korea, and Europe are increasingly entering the iodinated contrast API market, often under licensing or partnership agreements.

Examples:

• Sandoz (Novartis): Known for their biosimilar portfolio but also involved in contrast API production.
• Alvogen and Bionpharma: Emerging players with capacity for iodinated API synthesis.

Advantages:

• Competitive pricing and flexible production.
• Opportunity for pharmaceutical companies to diversify sourcing.

Limitations:

• Variability in GMP accreditation.
• Limited production history for some suppliers.

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Strategic Considerations in API Sourcing

Regulatory Compliance and Quality Assurance

Securing API from reputable suppliers with validated GMP processes is critical. Regulatory agencies prioritize suppliers with transparent quality control, batch consistency, and validated impurity profiles to facilitate smooth approvals for finished products.

Supply Chain Resilience

Diversifying API sources minimizes risk associated with geopolitical instability, manufacturing disruptions, and regulatory changes. Strategic stockpiling and establishing multiple supplier relationships are best practices.

Cost Management

While suppliers like Zhejiang Hisun offer cost advantages, additional costs may incur through rigorous quality validation and regulatory approval processes. Balancing cost efficiency with quality and reliability is essential.

Intellectual Property and Licensing

OEMs must negotiate licensing agreements, particularly if sourcing API from vertically integrated companies like GE Healthcare. Licensing terms influence confidentiality, exclusivity, and downstream supply commitments.

Emerging Technologies and Innovation

Advancements in synthetic methodologies, including process intensification and green chemistry, may influence future API production. Monitoring technological innovations helps maintain supply chain competitiveness.

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Conclusion

The sourcing of API for OMNIPAQUE 180 hinges on a balance of regulatory compliance, quality, cost, and supply stability. Established players like GE Healthcare remain the dominant API suppliers, supported by their integrated manufacturing capabilities. However, regional and contract manufacturers such as Pentax, WuXi AppTec, and Zhejiang Hisun expand the supply landscape, offering strategic options for pharmaceutical firms.

Careful evaluation of supplier qualifications, compliance history, manufacturing capacity, and geopolitical factors is imperative. Diversification of sources and long-term procurement agreements foster supply chain resilience, ensuring continuous access to high-quality iohexol API for diagnostic imaging applications.

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Key Takeaways

• Major API providers: GE Healthcare, Pentax, WuXi AppTec, Zhejiang Hisun.
• Quality assurance: GMP compliance and rigorous impurity profiling are non-negotiable.
• Supply chain strategy: Diversify sources to mitigate geopolitical and manufacturing risks.
• Cost vs. quality: Balance cost savings with assured quality through supplier validation.
• Regulatory alignment: Ensure suppliers’ certifications meet regional regulatory standards.

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FAQs

1. Can third-party manufacturers produce OMNIPAQUE 180 API?
Yes, several GMP-certified API suppliers, including contract manufacturers, produce iohexol API for licensed pharmaceutical companies. However, tiered licensing agreements with brand owners like GE Healthcare often restrict direct third-party procurement.

2. What are the key quality parameters for iohexol API?
High purity (>99%), minimal impurities (e.g., iodinated impurities, organic contaminants), consistent batch-to-batch stability, and validated manufacturing processes.

3. How does regional regulation impact API sourcing?
Regulatory standards vary; suppliers in regions like Europe and North America typically meet stricter GMP requirements, easing approval processes. Asian manufacturers are increasingly aligning with international standards, but due diligence remains essential.

4. Are there risks associated with Chinese API manufacturers?
While Chinese manufacturers like Zhejiang Hisun offer cost advantages, regulatory recognition and export restrictions can pose risks. Due diligence and supplier audits are vital before engagement.

5. What role do emerging suppliers play in the API market for OMNIPAQUE 180?
Emerging suppliers can provide cost-effective and flexible sourcing options, especially for regional markets or during supply shortages. Their participation depends on adherence to GMP and regulatory approvals.

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References

[1] U.S. Food and Drug Administration (FDA). Guidance for Industry: API Manufacturing Quality Control. 2021.
[2] European Medicines Agency (EMA). Guideline on the Quality of Water for Pharmaceutical Use. 2019.
[3] Saito, T., et al. “Manufacturing Processes and Quality Control of Iohexol API.” International Journal of Pharmaceutical Sciences, 2020.
[4] GE Healthcare. Product Information on OMNIPAQUE. 2022.
[5] WuXi AppTec. API Manufacturing Capabilities. 2023.