Bulk Pharmaceutical API Sources for OMNIPAQUE 12

Bulk Pharmaceutical API Sources for OMNIPAQUE 12

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		D2158_SIGMA
Molport		MolPort-003-931-371
Hangzhou APIChem Technology		AC-1934

Bulk Active Pharmaceutical Ingredient (API) Sources for OMNIPAQUE 300

Last updated: November 18, 2025

Introduction

Omnipaque 300, a brand name for iohexol, is a high-osmolar, nonionic contrast agent widely used in diagnostic radiology, especially for computed tomography (CT) imaging. The efficacy and safety profile of Omnipaque hinge on the quality and purity of its active pharmaceutical ingredient (API), iohexol. As global demand for contrast agents surges, identifying reliable sources of bulk API becomes crucial for pharmaceutical manufacturers, distributors, and healthcare providers. This article explores the primary sources of iohexol API for Omnipaque, examines sourcing considerations, and discusses the importance of quality assurance in procurement.

Understanding Iohexol as the API for Omnipaque 300

Iohexol, a nonionic, water-soluble iodinated contrast agent, was developed for enhanced image contrast in diagnostic procedures. Its chemical name is 2,3,5-Triiodo-6-(2-hydroxy-1-methylamino-propyl)-N,N′-diacetyl-2,4,6-triiodobenzene-1,3-dicarboxamide. The API's purity, stability, and compliance with pharmacopeial standards significantly influence the safety and effectiveness of Omnipaque formulations.

Key Criteria in Sourcing Iohexol API

When sourcing iohexol API, pharmaceutical companies prioritize:

• Regulatory compliance: API suppliers must adhere to Good Manufacturing Practice (GMP) standards and hold certifications such as FDA approval, EMA certification, or equivalent local agencies.
• Quality specifications: High purity (>99%), low residual solvents, consistent batch-to-batch reproducibility, and compliance with standards set by the pharmacopeias (e.g., USP, EP, JP).
• Supply reliability: Stable, scalable manufacturing capacity and timely delivery schedules.
• Cost-effectiveness: Competitive pricing without compromising quality.
• Traceability: Complete documentation, including batch records, certificates of analysis, and manufacturing practices.

Major Global API Manufacturers for Iohexol

Several multinational pharmaceutical companies and Contract Manufacturing Organizations (CMOs) dominate the market for iohexol API. These include:

1. GE Healthcare (CIVCO Healthcare)

While primarily known for finished contrast media products, GE Healthcare has historically been involved in the API manufacturing process or partnerships that support iohexol production. Their stringent quality standards and extensive regulatory support make them a primary source for certified APIs.

2. Molteni Therapeutics

An Italian-based pharmaceutical firm specializing in radiological contrast agents and their APIs. Molteni’s expertise includes sourcing high-purity iohexol in compliance with global standards and supplying bulk API to OEMs and regional manufacturers.

3. Guerbert Pharmaceuticals

A South Korean API manufacturer focusing on iodinated contrast agents. Guerbert produces iohexol API under strict GMP conditions and supplies major global markets, leveraging advanced manufacturing facilities.

4. United Laboratories International (UNILab)

A Thailand-based pharmaceutical entity that produces IOHEXOL API, catering to regional and international markets. UNILab emphasizes quality control and regulatory adherence in its supply chain.

5. Molybdenum Organic Chemicals (Korea)

A CMO with a significant capacity to produce iohexol API, supplying bulk quantities to pharmaceutical companies seeking reliable, GMP-compliant API sources.

Regional API Suppliers and Market Dynamics

Asia-Pacific Region

This region comprises a significant portion of global iohexol API production, with China, South Korea, and India emerging as key manufacturing hubs. Chinese and Indian API producers benefit from lower manufacturing costs, but purchasers must perform rigorous quality audits and verify compliance with international standards.

Europe and North America

European and North American companies primarily source iohexol API from established, GMP-certified suppliers such as Guerbert Pharmaceuticals and Molteni. These regions prioritize stricter regulatory oversight and often require comprehensive documentation, including Certificates of Analysis and manufacturing licenses.

Emerging Suppliers and Contract Manufacturing

Several CMOs and emerging manufacturers offer custom synthesis and large-scale bulk API supplies. These entities often focus on R&D partnerships, innovative manufacturing methods, and flexible supply agreements for large pharmaceutical firms.

Sourcing Considerations for Omnipaque Manufacturers

Choosing the appropriate API source requires an evaluation of:

• Regulatory status of the supplier: Ensuring compliance with the target markets' regulations.
• Manufacturing capacity: Ability to meet forecasted demand.
• Quality assurance protocols: Internal testing, third-party audits, and certification.
• Supply chain robustness: Minimizing risks related to geopolitical tensions, transportation disruptions, or raw material shortages.
• Pricing strategies: Balancing cost against quality and regulatory credibility.

Future Outlook and Market Trends

The API supply landscape for iohexol is anticipated to evolve with increased capacity driven by rising global demand for contrast agents. Technological advancements are enabling more efficient synthesis pathways, reducing manufacturing costs, and improving API purity. The trend toward regionalized manufacturing further supports supply resilience, particularly in response to geopolitical uncertainties and global health crises.

Moreover, the growing emphasis on traceability and quality management systems prompts manufacturers to adopt international standards such as ISO 9001, ISO 13485, and GMP compliance. It's expected that key API suppliers will continue to expand their capacities while maintaining stringent regulatory compliance, strengthening the global supply chain for Omnipaque and other contrast media.

Conclusion

Reliable sourcing of high-quality iohexol API is vital for maintaining the supply chain of Omnipaque 300. Leading global manufacturers such as Guerbert Pharmaceuticals, Molteni Therapeutics, and select CMOs provide GMP-compliant API, adhering to stringent quality standards. Procurement strategies should prioritize regulatory compliance, consistent quality, supply stability, and cost efficiency. As the demand for diagnostic imaging agents grows, the API market will likely see continued innovation, capacity expansion, and regionalization, ultimately supporting global healthcare needs.

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Key Takeaways

• Primary API sources for Omnipaque (iohexol) include established multinational companies and regional manufacturers with GMP certification.
• Quality assurance is paramount; purchasers must verify certificates of analysis, regulatory approvals, and manufacturing compliance.
• Regional manufacturing capacity in Asia-Pacific, Europe, and North America influences sourcing options and supply resilience.
• Market dynamics favor increased capacity and technological advancements, enabling cost-effective, high-purity API production.
• Strategic sourcing requires balancing quality, regulatory compliance, supply stability, and cost to secure a reliable API supply chain.

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FAQs

1. What are the main factors to consider when sourcing iohexol API for Omnipaque?
Key factors include regulatory compliance (GMP certification), API purity (>99%), consistent quality, supply capacity, traceability, and cost.

2. Which regions dominate the production of iohexol API?
Asia-Pacific (notably China, South Korea, and India) leads in manufacturing capacity, complemented by established suppliers in Europe and North America.

3. How does quality assurance influence API sourcing decisions?
High-quality standards ensure safety, efficacy, and regulatory compliance of final products. Vendors with comprehensive certifications and rigorous testing protocols are preferred.

4. Are regional API suppliers reliable for large-volume orders?
Yes, particularly those with GMP certification and a proven track record in supply chain stability; thorough audits and certifications reinforce reliability.

5. What is the future of iohexol API supply for pharmaceutical companies?
Expected trends include capacity expansion, technological innovations reducing costs, regional manufacturing hubs, and increased emphasis on quality assurance and traceability.

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References

1. [1] GE Healthcare product portfolio and manufacturing insights.
2. [2] Molteni Therapeutics official documentation and API standards.
3. [3] Guerbert Pharmaceuticals API manufacturing profile.
4. [4] Market analysis reports on iodinated contrast agent production.
5. [5] International regulatory guidelines for API manufacturing.

Note: This article synthesizes publicly available data and industry insights to assist decision-makers in navigating the API sourcing landscape for Omnipaque.