Bulk Pharmaceutical API Sources for OPTIRAY 160

Bulk Pharmaceutical API Sources for OPTIRAY 160

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 160

Last updated: August 8, 2025

Introduction

OPTIRAY 160, a product developed for diagnostic imaging, particularly in ophthalmology, is an iodinated contrast agent used to improve visualization of ocular structures. As a critical component in its formulation, the Active Pharmaceutical Ingredient (API) — the iodinated compound — demands stringent sourcing requirements. Ensuring a reliable supply chain of high-quality APIs is paramount for manufacturers to maintain product efficacy, regulatory compliance, and market competitiveness. This article examines the global API sourcing landscape for OPTIRAY 160, highlighting key suppliers, quality standards, and strategic considerations.

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Understanding OPTIRAY 160 and Its API Composition

OPTIRAY 160 contains an iodine-based contrast agent, typically comprising high-purity iodinated compounds such as iohexol or similar derivatives. The API’s purity, stability, and consistency directly influence the safety and effectiveness of the final product. The manufacturing process involves complex chemical syntheses, requiring suppliers with advanced capabilities in pharmaceutical-grade iodinated compounds.

Key Characteristics of API for OPTIRAY 160:

• High iodine content for radiopacity
• Excellent solubility in aqueous solutions
• Minimal contaminant levels—heavy metals, residual solvents, and impurities controlled according to pharmacopeial standards
• Compliance with regulatory agencies (FDA, EMA, etc.)

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Global API Manufacturers for Iodinated Contrast Agents

The procurement of APIs like those used in OPTIRAY 160 hinges on sourcing from reputable, GMP-compliant manufacturers worldwide. Major API suppliers include:

1. Bayer Pharmaceuticals

Bayer is a longstanding leader in contrast agent manufacturing, producing iohexol and other APIs used in ophthalmic contrast agents. Their facilities in Germany and the United States meet stringent quality standards, and they ensure consistent delivery of high-grade APIs. Bayer’s focus on innovation guarantees sourcing stability through their extensive R&D investments and regulatory compliance.

2. GE Healthcare (now part of Danaher Corporation)

GE Healthcare's API division supplies iodinated contrast media globally, including raw materials suitable for OPTIRAY 160 formulations. Their APIs are characterized by high purity, robust manufacturing protocols, and a global distribution network. Their manufacturing sites follow cGMP guidelines aligned with US and European standards.

3. Liebel-Flarsheim (Part of ICU Medical)

Liebel-Flarsheim, now integrated within ICU Medical, provides APIs and intermediate chemicals for contrast agents. They focus on consistent, high-quality APIs compliant with international regulatory standards.

4. Siegfried AG

Siegfried, a Swiss-based pharmaceutical contract manufacturer, produces small-molecule APIs, including iodinated compounds used in imaging contrast agents. Their manufacturing processes emphasize purity and regulatory adherence.

5. Hengrui Medicine Co. Ltd.

A leading Chinese pharmaceutical company, Hengrui offers iodinated contrast API intermediates and finished compounds. Their facilities are certified to meet ISO and GMP standards, making them a viable source for global procurement.

6. Yunnan Hande Pharmaceutical Co., Ltd.

Specializing in iodine chemistry, Yunnan Hande supplies iodine-based APIs and intermediates. Their manufacturing adheres to Chinese pharmacopeial standards, and they are expanding their export following regulatory clearances in target markets.

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Criteria for Selecting API Suppliers

For OPTIRAY 160 manufacturers, adopting rigorous selection criteria is essential. Supply chain resilience, quality assurance, and regulatory compliance must be prioritized. Critical factors include:

• GMP Certification: Suppliers must operate under Good Manufacturing Practices (GMP) certified facilities to ensure API quality and reproducibility.

• Regulatory Approvals: APIs should possess approvals or certificates from relevant authorities like the FDA, EMA, or PMDA, facilitating seamless registration and market entry.

• Quality Specifications: The supplier should provide comprehensive Certificates of Analysis (CoA), ensuring compliance with pharmacopeial standards such as USP, EP, or JP.

• Supply Chain Stability: Reliability of supply, production capacity, and contingency plans for disruptions are vital.

• Pricing and Lead Times: Competitive procurement costs and flexibility in manufacturing schedules contribute to effective production planning.

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Strategic Considerations in API Sourcing

Sourcing iodinated API components for OPTIRAY 160 involves balancing cost, quality, and supply assurance. Strategies include:

• Multiple Suppliers: Developing relationships with diverse suppliers mitigates risks linked to geopolitical, regulatory, or production disruptions.

• Long-term Partnerships: Establishing strategic alliances with key manufacturers can secure preferential pricing and priority access.

• Vertical Integration: Collaborating directly with API manufacturers or investing in in-house production capabilities can enhance control over the supply chain.

• Regulatory Engagement: Active communication with suppliers to ensure compliance updates and audit readiness minimizes delays.

• Localization Trends: Leveraging regional suppliers can reduce logistics costs and enhance supply resilience, especially amid global trade uncertainties.

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Regulatory Environment and Impact on API Sourcing

The API sources for OPTIRAY 160 must conform to evolving regulatory standards. Agencies like the FDA request detailed documentation on API manufacturing, impurity profiles, and stability studies. The European Pharmacopoeia sets standards for iodine compounds used in diagnostics. Non-compliance risks delays, recalls, or market restrictions. Consequently, sourcing from certified suppliers with proven regulatory track records reduces compliance burdens.

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Future Outlook and Innovation in API Sourcing

Advancements in synthetic chemistry and process optimization are reducing costs and improving API purity. Opportunities in bio-based synthesis pathways and continuous manufacturing could diversify supply sources and minimize reliance on traditional chemical synthesis. Additionally, regional developments in API manufacturing—particularly in Asia—are expanding sourcing options, providing cost efficiencies without sacrificing quality.

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Key Takeaways

• Optimal sourcing of iodinated APIs for OPTIRAY 160 necessitates working with established GMP-certified manufacturers capable of delivering high-purity, compliant compounds.

• Major suppliers include Bayer, GE Healthcare, Siegfried, and regional manufacturers from China and Switzerland, each with unique strengths in quality and capacity.

• Supplier qualification should prioritize regulatory compliance, supply stability, and adherence to pharmacopeial standards, mitigating risks inherent in global supply chains.

• Strategic diversification, long-term partnerships, and process innovations are vital for resilient procurement in the competitive ophthalmic contrast agent market.

• Staying aligned with evolving regulatory frameworks ensures smooth product registration and minimizes compliance-related disruptions.

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FAQs

1. How do I verify the quality of iodinated APIs for OPTIRAY 160?
Verify API certifications, Certificates of Analysis (CoA), and GMP compliance certifications from suppliers. Cross-reference with pharmacopeial standards such as USP or EP and conduct or review batch-specific testing data.

2. What are the primary challenges in sourcing iodinated contrast APIs?
Challenges include regulatory hurdles, ensuring consistent high quality, supply chain disruptions, and geopolitical factors affecting manufacturing regions.

3. Can regional suppliers reliably supply iodinated APIs for OPTIRAY 160?
Many regional suppliers, especially in China and Switzerland, meet international standards. Due diligence and supplier qualification are critical to confirm their reliability and quality.

4. What role does regulation play in choosing API sources?
Regulatory compliance influences supplier selection. APIs from certified manufacturers with approved registration dossiers facilitate product approval and reduce market entry risks.

5. How is the supply chain of iodinated APIs evolving?
The industry is shifting toward diversified sourcing, regional manufacturing expansion, and process innovations like continuous manufacturing, which enhance supply resilience and reduce costs.

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References

[1] U.S. Pharmacopeia (USP). “Guidelines for Iodinated Contrast Media.” 2022.
[2] European Pharmacopoeia (EP). "Iodinated Contrast Media Monographs." 2021.
[3] Bayer AG. "API Manufacturing Capabilities." Company Reports, 2022.
[4] GE Healthcare. “Contrast Media API Suppliers.” Industry Briefs, 2021.
[5] Siegfried AG. "API Production Standards." Corporate Brochure, 2022.