Bulk Pharmaceutical API Sources for OPTIRAY 320

Bulk Pharmaceutical API Sources for OPTIRAY 320

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
Alfa Chemistry		87771-40-2

Bulk Active Pharmaceutical Ingredient (API) Sources for OPTIRAY 320

Last updated: August 5, 2025

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Introduction

Optiray 320, a contrast agent primarily used in diagnostic imaging, is nominally associated with iohexol, a non-ionic, water-soluble iodinated contrast medium. The active pharmaceutical ingredient (API), iohexol, is central to the manufacturing, quality, and efficacy of Optiray 320. Understanding the sourcing landscape for API suppliers is critical for pharmaceutical manufacturers, regulatory compliance, and supply chain sustainability. This report delineates the global sources of iohexol API for Optiray 320, analyzing key manufacturers, supply chain dynamics, quality standards, and emerging trends.

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Overview of Iohexol API

Iohexol (C19H26I3N3O9) is a tri-iodinated benzene derivative characterized by its high iodine content, enhancing contrast in X-ray imaging. Its synthesis involves complex, multistep chemical processes requiring stringent quality control to meet pharmacopoeial standards—most notably, United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP).

The API’s global demand continues to grow, driven by increased diagnostic imaging across healthcare sectors. However, the procurement landscape remains concentrated among several specialized bulk API manufacturers.

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Major API Suppliers for Iohexol

1. GE Healthcare / General Electric

Market Position: Leading global manufacturer in contrast media APIs, including iohexol.
Manufacturing Capabilities: GE Healthcare's manufacturing facilities in Europe and India produce high-quality iohexol API compliant with international standards. They leverage extensive R&D, with processes optimized for batch consistency and purity.
Supply Chain Dynamics: As a dominant market player, GE Healthcare supplies both their proprietary Optiray formulations and custom API orders to OEMs and generic manufacturers. Their global distribution network ensures supply stability.

2. Bayer AG

Market Position: Historically associated with contrast agent development, Bayer is a key supplier of IOHEXOL API, integrating quality control aligned with pharmacopoeial standards.
Manufacturing Capabilities: Bayer’s facilities in Germany and India blend proprietary synthesis techniques to optimize yield, purity, and cost-efficiency.
Supply Chain Dynamics: Bayer’s strategic focus on high-standard API production positions it as a preferred supplier, especially for high-volume OEMs seeking reliable supply.

3. Hangzhou Shuanghe Pharmaceutical Co., Ltd. (China)

Market Position: Not a traditional pharmaceutical titan but has emerged as a significant API manufacturer owing to China's expanding API manufacturing capacity.
Manufacturing Capabilities: In compliance with Good Manufacturing Practices (GMP), Shuanghe produces iohexol API at scale, targeting domestic and international markets.
Supply Chain Dynamics: Cost-effective production and growing international certifications have made Shuanghe a competitive source for generic manufacturers.

4. Liaoning Aojin Pharmaceutical Co., Ltd. (China)

Market Position: Increasingly recognized for producing high-quality iodinated contrast agent APIs, including iohexol.
Manufacturing Capabilities: Facilities are GMP-certified, with export licenses enabling international trade, especially in Asia, Africa, and emerging markets.
Supply Chain Dynamics: Cost advantages and rapid scaling have made Liaoning Aojin attractive, although quality assurance remains critical for compliance.

5. SKOPje Pharmaceutical (North Macedonia)

Market Position: Niche supplier of pharmaceuticals, including specialty APIs such as iohexol.
Manufacturing Capabilities: Focused facilities with stringent quality control processes; aligned with European quality standards.
Supply Chain Dynamics: Acts mainly as an exporter to European markets, providing a reliable source of high-purity API.

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Emerging Market Trends and Supply Chain Considerations

a. Geographical Diversification
Traditional suppliers like GE Healthcare and Bayer maintain a dominant position in high-quality API supply. However, aggressive API manufacturing investments in China and India have diversified the supply landscape, offering cost-effective alternatives with adequate quality controls.

b. Regulatory and Quality Standards
Manufacturers must adhere to cGMP standards and obtain certifications (e.g., EMA, US FDA, PMDA). Manufacturers from China and India are increasingly achieving these benchmarks, which broadens their credibility.

c. Supply Chain Risks
Concentration among a few large players poses risks of supply disruptions due to geopolitical issues, raw material shortages (notably iodide compounds), or regulatory scrutiny. Diversification with multiple certified suppliers is critical for resilience.

d. Development of Biosimilar and Generic APIs
Efforts by regional manufacturers intend to develop biosimilar-grade iohexol APIs, potentially lowering costs and improving supply flexibility.

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Quality Standards and Certification

Quality assurance is fundamental, with APIs requiring strict compliance with pharmacopoeial monographs. Manufacturers achieving certifications such as ISO 9001, ISO 13485, and GMP compliance facilitate smooth regulatory acceptance across markets. Batch-to-batch consistency, impurity profiles, and stability data remain top priorities.

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Regulatory Landscape & Market Access

APIs sourced from global manufacturers must meet the regulatory requirements of target markets. For instance, the US FDA, EMA, and Japan’s PMDA impose rigorous standards, influencing supplier selection. Manufacturers with established regulatory dossiers streamline approval processes for final optical contrast formulations.

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Conclusion

The supply of iohexol API for Optiray 320 hinges on a combination of established global players—GE Healthcare and Bayer—and emerging Chinese and Indian manufacturers. While the leading multinationals offer high quality and reliable supply, regional suppliers provide cost efficiencies that may appeal to generic drug manufacturers or lower-volume markets. The evolving supply ecosystem promises increased diversity, provided quality assurances and regulatory compliance are maintained.

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Key Takeaways

• Major Suppliers: GE Healthcare and Bayer dominate high-quality iohexol API supply; regional Chinese manufacturers are gaining prominence.
• Supply Diversification: Amplifies resilience but necessitates rigorous quality oversight.
• Quality and Certification: Essential for regulatory approval; certifications like GMP, ISO enhance credibility.
• Market Trends: Cost-effective API sourcing is expanding in Asia, driven by manufacturing capacity and regulatory alignment.
• Supply Chain Strategy: Manufacturers should consider supplier diversification, quality assurances, and regulatory readiness to mitigate risks.

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FAQs

1. What are the primary regions producing iohexol API?
China and India have become major production hubs, complementing established manufacturers in Europe and North America.

2. How do quality standards influence API sourcing for Optiray 320?
Compliance with GMP and international pharmacopoeial standards overcomes regulatory barriers, ensuring safety and efficacy of the final contrast agent.

3. What risks are associated with relying on a limited number of API suppliers?
Supply disruptions, quality variability, and geopolitical issues could jeopardize production continuity, underscoring the importance of diversification.

4. Are Chinese API manufacturers suitable for use in high-end markets like the US or Europe?
Yes, with appropriate certifications and quality controls, many Chinese manufacturers meet global regulatory standards, but due diligence is critical.

5. How might emerging manufacturing technologies impact iohexol API supply?
Advances such as continuous manufacturing and process optimizations can reduce costs, improve quality, and enhance supply chain stability.

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References

[1] U.S. Pharmacopeia. Iohexol Monograph.
[2] European Pharmacopoeia. Iohexol Specification.
[3] Market research reports on contrast media API manufacturing.
[4] Company websites: GE Healthcare, Bayer AG, Chinese API manufacturers’ certifications and capacity data.