Bulk Pharmaceutical API Sources for ISOVUE-128

Bulk Pharmaceutical API Sources for ISOVUE-128

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-848-224
Amadis Chemical		A834067
AKos Consulting & Solutions		AKOS015891034
AbaChemScene		CS-2917
MedChemexpress MCE		HY-B0684
Key Organics/BIONET		KS-1421
BOC Sciences		60166-93-0

Bulk Active Pharmaceutical Ingredient (API) Sources for ISOVUE-128

Last updated: February 19, 2026

This report details current and potential bulk Active Pharmaceutical Ingredient (API) sources for ISOVUE-128. ISOVUE-128 is a non-ionic, iodinated contrast medium primarily used in medical imaging procedures. The analysis focuses on identified manufacturers, their geographic locations, and estimated production capacities where publicly available. This data supports R&D and investment decisions concerning supply chain security and market entry for ISOVUE-128.

Who Manufactures ISOVUE-128 API?

The primary manufacturer of ISOVUE-128 is Bracco Diagnostics Inc. They produce the API internally at their facilities. However, due to the specialized nature of iodinated contrast media, other contract manufacturing organizations (CMOs) or API suppliers may be involved in intermediate production or have the capability to produce similar iodinated compounds. Identification of alternative, independent API suppliers is challenging due to proprietary manufacturing processes and supply chain confidentiality.

Bracco Diagnostics Inc.

Bracco Diagnostics Inc. is the originator and primary supplier of ISOVUE-128. Their API is manufactured to their proprietary specifications.

• Primary Manufacturing Site: Bracco's main API production for ISOVUE-128 is understood to be located in their facilities. Specific details on internal API production sites are not publicly disclosed.
• Global Presence: Bracco Diagnostics Inc. is a global pharmaceutical company with operations and distribution networks worldwide.

Potential Contract Manufacturing Organizations (CMOs)

While no specific CMOs are publicly listed as direct ISOVUE-128 API suppliers, companies specializing in complex organic synthesis, particularly those with expertise in iodinated compounds and Good Manufacturing Practices (GMP) compliance, are potential candidates for contract manufacturing.

• Geographic Focus of API Manufacturing: Major regions with significant API manufacturing capabilities for complex molecules include China, India, and Europe.
  • China: Has a large volume of API production, often with competitive pricing, though GMP compliance and intellectual property concerns can be factors.
  • India: A global leader in generic API production, with a growing number of companies capable of complex synthesis and adherence to international regulatory standards.
  • Europe: Home to many established pharmaceutical ingredient manufacturers with strong regulatory track records and advanced technical capabilities, often at a higher cost.

Companies Specializing in Iodinated Contrast Media Precursors

The synthesis of iodinated contrast media involves multiple complex chemical steps. Companies that produce key iodinated intermediates or related fine chemicals could potentially be involved in the broader supply chain, even if not directly manufacturing the final ISOVUE-128 API.

• Example Intermediates: The synthesis of iodinated contrast agents typically involves building blocks like triiodobenzoic acid derivatives. Companies producing such precursors are critical to the supply chain.

What is the Production Capacity for ISOVUE-128 API?

Exact production capacities for proprietary APIs like ISOVUE-128 are confidential business information. However, inferences can be made based on market demand and the scale of Bracco Diagnostics' operations.

• Bracco's Market Share: As the originator, Bracco holds a significant share of the market for ISOVUE-128. This implies a substantial internal production capacity to meet global demand for their branded product.
• Estimated Global Demand: The global market for contrast media is substantial, measured in billions of dollars annually. ISOVUE-128 is a widely used product within this market, suggesting that its API production volume is considerable, likely in the metric ton range per year.
• Scalability: Pharmaceutical API manufacturing facilities are designed for scalability. Bracco's facilities are equipped to adjust production based on market demand fluctuations.

Factors Influencing Production Capacity

• Regulatory Compliance: API manufacturing must adhere to stringent GMP regulations. Production capacity is inherently linked to the ability to maintain these standards consistently.
• Raw Material Availability: The supply chain for specialized raw materials, particularly iodine and complex organic precursors, directly impacts production capacity.
• Process Efficiency: Advances in chemical synthesis and manufacturing technology can increase throughput and thus, effective capacity.

What are the Key Chemical Specifications and Regulatory Requirements?

The quality and purity of ISOVUE-128 API are paramount for patient safety and efficacy. Production must adhere to strict pharmacopeial standards and regulatory filings.

Chemical Specifications

ISOVUE-128 is a specific formulation of iohexol. The API, iohexol, has well-defined chemical and physical properties.

• Chemical Name: 5-[N-(2,3-Dihydroxypropyl)acetamido]-2,4,6-triiodo-N,N'-bis(2,3-dihydroxypropyl)isophthalamide
• Molecular Formula: C₂₄H₃₁I₃N₂O₁₁
• Molecular Weight: 821.25 g/mol
• Purity: High purity is required, typically >99%, with strict limits on related substances, residual solvents, and heavy metals.
• Appearance: White to off-white crystalline powder.
• Solubility: Freely soluble in water.
• Iodine Content: A critical parameter, directly correlating to the radio-opacity of the contrast agent.

Regulatory Requirements

API manufacturing for human pharmaceuticals is highly regulated by global health authorities.

• Good Manufacturing Practices (GMP): Compliance with current GMP (cGMP) is mandatory. This covers all aspects of production, including facility design, equipment validation, personnel training, quality control, and documentation.
• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies (e.g., U.S. Food and Drug Administration - FDA, European Medicines Agency - EMA). A DMF contains detailed information about the manufacturing process, facilities, and quality controls for the API. Bracco Diagnostics maintains the DMF for its proprietary iohexol API.
• Pharmacopeial Standards: The API must meet the specifications outlined in major pharmacopeias, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.).
• Impurity Profiling: Regulatory agencies require thorough identification and control of impurities, including process-related impurities and degradation products.

Where is ISOVUE-128 API Likely Sourced from for Generic Formulations?

While Bracco Diagnostics is the originator and primary supplier of ISOVUE-128 (iohexol), generic versions of iohexol-based contrast media exist. The API for these generic products can be sourced from various manufacturers that have developed their own bioequivalent or therapeutically equivalent formulations.

• Key Generic Manufacturers: Companies that produce generic iohexol contrast media are the primary consumers of third-party iohexol API.
• Geographic Concentration of Generic API Production:
  • China: Many Chinese API manufacturers produce a wide range of pharmaceutical ingredients, including complex molecules. They are a significant source for generic APIs globally. Companies would need to ensure rigorous quality control and GMP adherence.
  • India: India is a powerhouse in generic API manufacturing, with numerous companies specializing in high-quality production for export. They have a strong regulatory track record.
  • European CMOs: Some European-based CMOs with specialized expertise in iodinated chemistry and advanced manufacturing may also produce iohexol API, often catering to markets with higher quality and regulatory demands.

Due Diligence for Generic API Sourcing

When sourcing generic iohexol API, comprehensive due diligence is critical.

• GMP Certification and Audits: Manufacturers must demonstrate adherence to cGMP through regular audits by regulatory bodies (e.g., FDA, EMA) and the potential buyer.
• DMF Status: A filed and accepted DMF with relevant regulatory agencies is a strong indicator of manufacturing process control and regulatory scrutiny.
• Quality Control and Analytical Capabilities: The supplier must have robust in-house quality control laboratories capable of testing against pharmacopeial standards and custom specifications.
• Supply Chain Transparency: Understanding the origin of raw materials and the overall manufacturing process is essential for risk management.

What are the Risks Associated with ISOVUE-128 API Sourcing?

Sourcing bulk APIs, especially for complex molecules like iohexol, carries inherent risks that can impact product quality, regulatory compliance, and supply chain continuity.

Supply Chain Risks

• Geopolitical Instability: Concentration of API manufacturing in specific regions can expose supply chains to risks from trade disputes, political unrest, or natural disasters.
• Raw Material Shortages: The availability of critical raw materials, such as iodine, can fluctuate due to global demand, environmental regulations, or supply disruptions.
• Logistical Challenges: Transportation of APIs requires specialized handling and storage to maintain integrity. Delays or mishandling can render batches unusable.

Quality and Regulatory Risks

• Counterfeit APIs: The pharmaceutical industry faces the persistent threat of counterfeit APIs. Thorough vetting of suppliers is necessary to prevent such infiltration.
• GMP Non-Compliance: A supplier's failure to maintain cGMP standards can lead to product recalls, regulatory sanctions, and damage to the brand.
• Impurity Issues: Unexpected or unacceptably high levels of impurities can arise from manufacturing process deviations, leading to batch rejection or regulatory action.

Intellectual Property Risks

• Patent Infringement: For generic APIs, ensuring that the manufacturing process does not infringe on existing patents held by the originator (Bracco Diagnostics) is crucial. This requires careful legal review.
• Proprietary Process Security: CMOs must have robust systems to protect client IP and prevent the unauthorized disclosure or use of manufacturing processes.

What are the Future Trends in API Sourcing for Contrast Media?

The pharmaceutical API sourcing landscape is continually evolving, driven by regulatory changes, technological advancements, and market dynamics.

Diversification of Manufacturing Bases

• Reducing Geographic Concentration: Pharmaceutical companies are increasingly looking to diversify their API manufacturing sites to mitigate risks associated with over-reliance on single regions or suppliers. This may lead to increased interest in API production capabilities in North America and Western Europe, in addition to traditional Asian hubs.

Advanced Manufacturing Technologies

• Continuous Manufacturing: The adoption of continuous manufacturing processes for API production offers potential benefits in terms of efficiency, quality control, and reduced waste.
• Process Analytical Technology (PAT): Integration of PAT allows for real-time monitoring and control of critical process parameters, enhancing consistency and reducing the likelihood of batch failures.

Sustainability and Green Chemistry

• Environmental Impact: There is growing pressure for API manufacturing to adopt more sustainable practices, including reducing solvent use, minimizing waste generation, and improving energy efficiency.
• Life Cycle Assessment: Companies are increasingly considering the environmental footprint of their API sourcing and manufacturing processes.

Digitalization and Supply Chain Transparency

• Blockchain Technology: The application of blockchain for supply chain tracking can enhance transparency, traceability, and security, helping to combat counterfeiting and improve recall management.
• Data Analytics: Advanced analytics can be used to predict supply chain disruptions, optimize inventory levels, and improve quality control.

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Key Takeaways

• Bracco Diagnostics Inc. is the primary manufacturer of ISOVUE-128 API (iohexol).
• Independent API sourcing for generic iohexol is concentrated in China and India, with potential capabilities in Europe.
• Production capacity figures for proprietary APIs are confidential, but substantial volumes are inferred from market demand.
• Adherence to cGMP, pharmacopeial standards, and stringent impurity profiling are critical regulatory requirements for API manufacturers.
• Key sourcing risks include geopolitical instability, raw material shortages, quality control failures, and intellectual property challenges.
• Future trends favor manufacturing diversification, advanced technologies like continuous manufacturing, and increased focus on sustainability and supply chain transparency.

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Frequently Asked Questions

1. Can any pharmaceutical manufacturer produce ISOVUE-128 API? No. The synthesis of iohexol is complex and requires specialized expertise, equipment, and strict adherence to Good Manufacturing Practices (GMP) mandated by regulatory authorities. Bracco Diagnostics Inc. is the originator and primary producer. Generic manufacturers must develop their own independently validated manufacturing processes and obtain regulatory approval.

2. How is the quality of ISOVUE-128 API ensured for generic products? Quality is ensured through rigorous testing against pharmacopeial standards (e.g., USP, Ph. Eur.) and the manufacturer's own validated specifications. This includes purity assays, impurity profiling, residual solvent analysis, and verification of physical properties. Regulatory agencies conduct inspections to ensure ongoing GMP compliance.

3. What are the primary raw materials for ISOVUE-128 API synthesis? The synthesis involves complex organic chemistry. Key components include derivatives of isophthalic acid and various iodine sources. The availability and quality of these precursors are critical for API production.

4. What is the typical lead time for sourcing bulk ISOVUE-128 API from a new supplier? The lead time can vary significantly, but typically ranges from 6 to 18 months. This period accounts for supplier qualification, audits, initial sample production, analytical method validation, process validation, and regulatory filing preparations.

5. Are there any major patent expiries relevant to ISOVUE-128 API that would open up more generic sourcing options? While specific patent expiry dates are proprietary and complex to track, the market for iohexol has seen generic competition. This indicates that key formulation patents or method-of-use patents relevant to Bracco's branded ISOVUE-128 have either expired or been successfully challenged, allowing other companies to enter the market with generic versions. However, specific manufacturing process patents may still be in force.

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Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/drug-master-files/drug-master-files-dmfs [2] European Medicines Agency. (n.d.). Active substances (APIs). Retrieved from https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapy-medicinal-products/active-substances-apis [3] United States Pharmacopeia. (n.d.). About USP. Retrieved from https://www.usp.org/about-usp [4] European Directorate for the Quality of Medicines & HealthCare (EDQM). (n.d.). European Pharmacopoeia. Retrieved from https://www.edqm.eu/en/european-pharmacopoeia