Bulk Pharmaceutical API Sources for OMNIPAQUE 210

Bulk Pharmaceutical API Sources for OMNIPAQUE 210

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

Bulk Active Pharmaceutical Ingredient (API) Sources for OMNIPAQUE 210

Last updated: August 1, 2025

Introduction

OMNIPAQUE 210 is a branded, ionically formulated X-ray contrast agent primarily composed of iohexol, an iodine-based compound. It is used extensively in medical imaging procedures for enhanced visualization of vascular structures and organ tissues. As a contrast agent, the quality and reliability of its active pharmaceutical ingredient (API), iohexol, are paramount for safety, efficacy, and regulatory compliance.

Securing a stable, reliable supply of high-quality iohexol API is essential for pharmaceutical manufacturers aiming to produce OMNIPAQUE 210. This article offers a comprehensive review of global API sourcing options, examining primary manufacturers, quality considerations, geographic trends, and supply chain dynamics relevant to the production of OMNIPAQUE 210.

Understanding Iohexol as an API for OMNIPAQUE 210

Iohexol is a nonionic, water-soluble iodine compound characterized by its high iodine content, low osmolality, and low toxicity profile. These properties make it suitable for intravascular contrast media applications. Its manufacture involves complex chemical synthesis processes that demand strict quality control and adherence to Good Manufacturing Practices (GMP).

For pharmaceutical companies, the API's sourcing not only impacts manufacturing costs but also influences regulatory approval, batch consistency, and overall product safety.

Major Iohexol API Manufacturers and Suppliers

1. GE Healthcare (U.S.)

GE Healthcare is the original developer and patent holder of iohexol, with manufacturing facilities primarily located in the United States and Europe. As the global leader, GE Healthcare supplies high-quality iohexol API through authorized distribution channels and direct procurement arrangements.

• Strengths: Proven GMP compliance, consistent supply, extensive regulatory documentation, and reliable quality control.
• Considerations: Premium pricing and limited external supply options due to patent protections and strategic control.

2. Tianjin Lansen Pharmaceutical (China)

Tianjin Lansen is a prominent Chinese manufacturer producing iohexol API for domestic and international markets. They have obtained GMP certification aligned with international standards, enabling exports to regulated markets.

• Strengths: Competitive pricing, rapid production capacity expansion, and a growing presence in global supply chains.
• Considerations: Variability in regulatory acceptance outside China; ongoing efforts to achieve rigorous international standards.

3. Jinzhou Realcan Pharmaceutical (China)

Jinzhou Realcan specializes in producing contrast media APIs, including iohexol, with a focus on quality assurance compliant with CE and other certifications.

• Strengths: Robust manufacturing capabilities, committed quality assurance, and strategic regional distribution.
• Considerations: Regulatory/Chemical dossier alignment for specific markets.

4. Other Notable Suppliers

• Nippon Kayaku (Japan): Historically involved in contrast media production, with reliable API quality.
• Pharmaceutical Divisions in India: Companies such as Sun Pharmaceutical Industries and Biocon have capacities to produce iohexol API, often serving local markets with potential for export.

Emerging and Alternative API Sources

While the primary supply chain revolves around established manufacturers, other firms in Asia and Europe are expanding capabilities to meet global demand. These include:

• Moscow-based companies developing generics to capitalize on lower manufacturing costs.
• European API producers focusing on specialty APIs with strict compliance standards.

Sourcing from these providers requires thorough vetting for regulatory compliance, API stability, and batch-to-batch consistency.

Supply Chain Considerations for API Sourcing

Quality and Regulatory Compliance

Strict adherence to GMP standards (e.g., EMA, FDA, PIC/S) is non-negotiable for APIs used in injectable products. Suppliers must provide detailed dossiers, stability data, and pharmacopoeial compliance documentation. Any deviation can lead to regulatory rejection or delays.

Pricing and Contracting

Pricing varies significantly between legacy providers like GE Healthcare and emerging Chinese manufacturers. Contract negotiations should include quality benchmarks, supply guarantees, intellectual property considerations, and contingency plans.

Supply Security

Global events, such as pandemics or geopolitical disruptions, initially impacting Chinese or regional suppliers, highlight the importance of diversifying sources. Maintaining multiple approved vendors mitigates supply risk.

Logistics and Lead Times

API lead times range from 3 to 6 months, depending on supplier location and regulatory validation processes. Early engagement and long-term supply agreements ensure uninterrupted production.

Intellectual Property and Licensing

While iohexol patents have expired in certain jurisdictions, licensing arrangements or authorized supplier status may influence procurement options, especially for branded products like OMNIPAQUE 210.

Regulatory and Procurement Strategies

• Due Diligence: Conduct comprehensive supplier audits and quality assessments.
• Qualification Processes: Initiate validation batches for regulatory submissions.
• Regional Compliance: Ensure API specifications align with regional pharmacopoeias (USP, EP, JP).
• Partnerships: Foster long-term relationships with established API manufacturers to secure priority access.

Future Trends in API Sourcing for Contrast Agents

The race for cost efficiency and supply resilience continues to prompt manufacturers to explore:

• API synthesis innovation reducing dependence on specific plant-based processes.
• Regional API production hubs to assure supply chain stability.
• Vertical integration by large pharmaceutical companies for critical APIs.

Emerging digital tracking and blockchain technology may further enhance supply chain transparency and compliance.

Key Takeaways

• The primary API source for OMNIPAQUE 210 remains GE Healthcare, but increased regional manufacturing has diversified supply options.
• Chinese manufacturers like Tianjin Lansen and Jinzhou Realcan present competitive, quality-assured alternatives with expanding global acceptance.
• Ensuring GMP compliance, regulatory approval, and transparency are critical for sourcing iohexol API.
• Diversification and early qualification of multiple API suppliers mitigate supply risks amid geopolitical and logistical uncertainties.
• Continuous monitoring of technological improvements and regional manufacturing initiatives will shape future sourcing strategies for contrast media APIs.

---

FAQs

1. How does the choice of API supplier impact the quality of OMNIPAQUE 210?
The supplier's GMP compliance, quality assurance processes, and regulatory adherence directly influence the API's purity, stability, and consistency, thereby affecting the safety and efficacy of the final product.

2. Are Chinese API manufacturers eligible for regulatory approval in Western markets?
Yes. Firms such as Tianjin Lansen and Jinzhou Realcan have obtained necessary certifications (GMP, CE) aligning with international standards, facilitating regulatory approval in regions like Europe, the U.S., and Japan.

3. What factors should be considered when evaluating API suppliers for OMNIPAQUE 210?
Assessment criteria include GMP certification, regulatory compliance, quality control measures, manufacturing capacity, lead times, pricing, supply chain stability, and track record with similar pharmaceutical products.

4. Can sourcing from multiple API manufacturers reduce supply disruptions for OMNIPAQUE 210?
Absolutely. Diversifying sources diminishes reliance on a single supplier, thus minimizing risks associated with regional disruptions, regulatory delays, or supply chain bottlenecks.

5. How does API cost influence the overall price of OMNIPAQUE 210?
API costs constitute a significant portion of manufacturing expenses; however, total product pricing also depends on formulation, branding, regulatory, and distribution factors. Strategic sourcing can optimize costs without compromising quality.

---

References

[1] GE Healthcare. "Iohexol (Omnipaque)" – Product dossier, 2022.
[2] Tianjin Lansen Pharmaceutical. "API Registration and GMP Certification," 2021.
[3] Jinzhou Realcan Pharmaceutical. "Quality Assurance and Regulatory Approvals," 2021.
[4] U.S. Food & Drug Administration (FDA). "Guidance for Industry: Pharmaceutical Quality System (ICH Q10)," 2008.
[5] European Medicines Agency (EMA). "Manufacturing authorizations for medicinal products," 2022.