Bulk Pharmaceutical API Sources for OPTIRAY 300

Bulk Pharmaceutical API Sources for OPTIRAY 300

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

OPTIRAY 300 Bulk API Sourcing

Last updated: February 19, 2026

This report details the bulk Active Pharmaceutical Ingredient (API) sourcing landscape for OPTIRAY 300, a contrast agent used in medical imaging. Key considerations include primary manufacturers, regulatory compliance, and potential supply chain risks.

What is the Chemical Composition of OPTIRAY 300?

OPTIRAY 300 is a non-ionic, iodinated contrast agent. Its active ingredient is ioversol. The concentration of ioversol in OPTIRAY 300 is 320 mg of iodine per mL, which corresponds to a 63.6% (w/v) concentration of ioversol.

Who are the Primary Manufacturers of Ioversol API?

The primary manufacturer of ioversol API is Guerbet, the originator company of OPTIRAY. Guerbet operates its own API manufacturing facilities, ensuring a vertically integrated supply chain.

Beyond Guerbet's internal production, the global API market for ioversol includes a limited number of qualified suppliers. These suppliers must meet stringent regulatory requirements from agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Key characteristics of approved ioversol API manufacturers include:

• Good Manufacturing Practices (GMP) Compliance: Facilities must adhere to international GMP standards.
• Regulatory Filings: Successful Drug Master File (DMF) submissions to regulatory authorities are mandatory.
• Quality Control Systems: Robust quality assurance and quality control processes are essential to ensure API purity and consistency.
• Supply Chain Transparency: Traceability of raw materials and production processes is critical.

Specific third-party manufacturers for ioversol API are not publicly disclosed by Guerbet or regulatory agencies. However, the general market for iodinated contrast media APIs includes specialized chemical manufacturers with expertise in complex organic synthesis and purification. These suppliers typically operate under contract manufacturing agreements.

What are the Regulatory Requirements for Ioversol API?

The sourcing of ioversol API for pharmaceutical use is governed by strict regulatory frameworks. These requirements ensure the safety, efficacy, and quality of the final drug product.

Key regulatory considerations include:

• FDA Regulations: In the United States, the FDA oversees API manufacturing and quality. Manufacturers must comply with 21 CFR Part 210 and 211, which detail current Good Manufacturing Practice (cGMP) for finished pharmaceuticals and API. A Drug Master File (DMF) must be filed with the FDA, providing confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs.
• EMA Regulations: In Europe, the European Medicines Agency (EMA) enforces similar standards. API manufacturers must comply with EudraLex Volume 4, which outlines GMP guidelines for medicinal products. A Certificate of Suitability (CEP) issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) or a European DMF is typically required.
• ICH Guidelines: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides harmonized guidelines that are widely adopted globally. Relevant ICH guidelines include:
  • ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
  • ICH Q11: Development and Manufacture of Drug Substances.
• Impurity Profiling: Manufacturers must rigorously control and monitor impurities in the API. This includes process-related impurities, degradation products, and residual solvents. Specifications for impurity levels are established based on toxicological data and regulatory limits.
• Analytical Methods: Validated analytical methods are required for testing API identity, strength, quality, and purity. These methods are detailed in the DMF or CEP.
• Audits and Inspections: Regulatory agencies conduct periodic inspections of API manufacturing sites to ensure ongoing compliance with GMP. Pharmaceutical companies also conduct supplier audits to qualify and monitor their API sources.

What are the Key Quality Specifications for Ioversol API?

The quality specifications for ioversol API are critical for ensuring the safety and efficacy of OPTIRAY 300. These specifications are established to control the physical and chemical characteristics of the API.

Typical quality specifications for ioversol API include:

• Assay (Purity): The minimum acceptable purity of ioversol. This is typically expressed as a percentage, for example, not less than 98.0% or 99.0% on an anhydrous basis.
• Related Substances (Impurities): Limits for specific known impurities and total impurities. These are often measured by High-Performance Liquid Chromatography (HPLC) and expressed as a percentage of the API. Examples of potential impurities include starting materials, intermediates, by-products of synthesis, and degradation products.
• Water Content: The maximum allowable amount of water, often determined by Karl Fischer titration.
• Residual Solvents: Limits for solvents used in the manufacturing process, as defined by ICH Q3C guidelines.
• Heavy Metals: Limits for contamination by heavy metals, typically specified in parts per million (ppm).
• Sulphated Ash/Residue on Ignition: A measure of inorganic impurities remaining after ignition.
• Appearance: Description of the physical form and color of the API (e.g., white to off-white crystalline powder).
• Particle Size Distribution: For solid APIs, particle size can impact dissolution rates and handling characteristics.
• Identification Tests: Tests to confirm the identity of the API, such as Infrared (IR) spectroscopy or HPLC retention time matching.

These specifications are detailed in the API manufacturer's Certificate of Analysis (CoA) for each batch and are cross-referenced in the drug product's regulatory filings.

What are the Potential Supply Chain Risks for Ioversol API?

The sourcing of specialized APIs like ioversol carries inherent supply chain risks that can impact the availability and cost of finished drug products.

Key supply chain risks include:

• Limited Supplier Base: As noted, the market for ioversol API is concentrated. A reliance on a small number of manufacturers creates vulnerability to disruptions at any of these sites.
• Geopolitical Instability: API manufacturing often relies on global supply chains for raw materials and intermediates. Geopolitical events, trade disputes, or conflicts in key sourcing regions can disrupt production and logistics.
• Regulatory Changes: Evolving regulatory requirements or unexpected enforcement actions can lead to production halts or costly remediation efforts for API manufacturers. This includes stricter impurity limits or new environmental regulations.
• Natural Disasters and Pandemics: Unforeseen events such as earthquakes, floods, or global health crises (e.g., COVID-19) can severely impact manufacturing operations, labor availability, and transportation.
• Raw Material Availability and Cost Fluctuations: The synthesis of ioversol requires specific chemical precursors. Disruptions in the supply of these raw materials, or significant price volatility, can affect API production costs and lead times.
• Quality Incidents: A quality failure at an API manufacturing site, resulting in a product recall or manufacturing suspension, would immediately impact supply.
• Intellectual Property and Exclusivity: While patents on the OPTIRAY 300 drug product may expire, Guerbet likely maintains intellectual property protection related to specific manufacturing processes or polymorphs of ioversol. This can influence who can manufacture and supply the API.

Mitigation strategies for these risks include dual sourcing where feasible, robust supplier qualification and monitoring programs, maintaining safety stock inventories, and developing contingency plans for production interruptions.

What are the Commercial Implications of API Sourcing for OPTIRAY 300?

The sourcing of ioversol API has direct implications for the commercial viability and market position of OPTIRAY 300.

Commercial implications include:

• Cost of Goods Sold (COGS): The price of ioversol API is a significant component of the COGS for OPTIRAY 300. Fluctuations in API pricing directly impact gross margins.
• Market Exclusivity and Competition: Guerbet's control over its proprietary API manufacturing provides a degree of market exclusivity. As patents expire, the availability of third-party API sources will be a critical factor for potential generic competition. The cost and quality of independently sourced API will determine the economic feasibility for generic manufacturers.
• Supply Reliability: Consistent and reliable access to high-quality API is paramount for meeting market demand and avoiding stock-outs. Supply disruptions can lead to lost sales and damage brand reputation.
• Regulatory Approval Timelines: For any new entrant seeking to market a generic version of OPTIRAY 300, securing a qualified and regulatory-compliant API supplier is a critical path item. The DMF status and inspection history of the API manufacturer will influence approval timelines.
• Strategic Partnerships: Pharmaceutical companies often establish long-term supply agreements with their API manufacturers. These agreements can include volume commitments, price adjustments, and quality improvement initiatives.
• Geographic Manufacturing Footprint: The location of API manufacturing sites can influence logistics costs, lead times, and exposure to regional regulatory or geopolitical risks.

What is the Market Size and Growth Outlook for Iodinated Contrast Media APIs?

The market for iodinated contrast media (ICM) APIs, including ioversol, is driven by the global demand for diagnostic imaging procedures. This demand is influenced by several factors.

Key market drivers:

• Aging Population: An increasing elderly population leads to a higher incidence of diseases requiring imaging, such as cardiovascular conditions and cancer.
• Advancements in Imaging Technology: Improvements in CT and MRI scanners enable more detailed imaging, often requiring contrast agents.
• Increasing Healthcare Access: Expanding healthcare infrastructure and access in emerging economies contributes to higher utilization of diagnostic imaging.
• Growing Prevalence of Chronic Diseases: The rising rates of chronic diseases, particularly cardiovascular disease and cancer, necessitate diagnostic imaging for detection, staging, and monitoring.

Market trends:

• Dominance of Non-Ionic Dimers: Agents like ioversol (a non-ionic dimer) represent a significant segment due to their favorable safety profiles compared to older ionic agents.
• Competition from Other Contrast Classes: While ICM remain dominant, competition from MRI contrast agents (e.g., gadolinium-based agents) and ultrasound contrast agents exists.
• Price Sensitivity: Healthcare systems are increasingly focused on cost containment, which can influence pricing pressures on contrast agents and their APIs.
• Consolidation: The pharmaceutical and API manufacturing sectors have seen consolidation, which can impact supplier availability and market dynamics.

While specific market size figures for ioversol API alone are proprietary, the global market for iodinated contrast media is substantial. Estimates from various market research firms place the global contrast media market in the range of \$5 billion to \$7 billion annually. The API segment represents a significant portion of this value, driven by the complex synthesis and high purity requirements. Growth rates for the overall contrast media market are generally projected to be in the low to mid-single digits annually, reflecting mature markets and evolving treatment paradigms.

Key Takeaways

• OPTIRAY 300's active pharmaceutical ingredient is ioversol, manufactured by Guerbet and a limited number of qualified third-party API suppliers.
• Ioversol API manufacturing requires strict adherence to global GMP standards and regulatory filings (DMF/CEP) with agencies like the FDA and EMA.
• Key quality specifications focus on purity, impurity profiles, water content, and residual solvents.
• Supply chain risks are concentrated due to a limited supplier base, geopolitical factors, regulatory changes, and raw material availability.
• API sourcing directly impacts the cost of goods, market exclusivity, and the potential for generic competition for OPTIRAY 300.
• The market for iodinated contrast media APIs is driven by an aging population, technological advancements in imaging, and rising chronic disease prevalence, with growth projected in the low to mid-single digits.

Frequently Asked Questions

What is the primary chemical compound in OPTIRAY 300?

The primary chemical compound in OPTIRAY 300 is ioversol.

Who is the main manufacturer of OPTIRAY 300?

Guerbet is the main manufacturer of OPTIRAY 300.

Does Guerbet manufacture its own ioversol API?

Yes, Guerbet has internal API manufacturing capabilities for ioversol.

Are there other companies that manufacture ioversol API?

Yes, there are a limited number of qualified third-party manufacturers that produce ioversol API under contract.

What regulatory bodies oversee the manufacturing of ioversol API?

Regulatory bodies include the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), among others.

Citations

[1] U.S. Food and Drug Administration. (n.d.). 21 CFR Part 210 - Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; general. Electronic Code of Federal Regulations. Retrieved from https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-210 [2] U.S. Food and Drug Administration. (n.d.). 21 CFR Part 211 - Current good manufacturing practice for finished pharmaceuticals. Electronic Code of Federal Regulations. Retrieved from https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 [3] European Medicines Agency. (n.d.). EudraLex - The Rules Governing Medicinal Products in the European Union. Retrieved from https://ec.europa.eu/health/human-use/eudralex_en [4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Harmonised Guidelines. Retrieved from https://www.ich.org/guidelines/harmonised-guidelines [5] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability (CEP). Retrieved from https://www.edqm.eu/en/certificate-suitability-cep