Suppliers and packagers for generic pharmaceutical drug: IOHEXOL

IOHEXOL

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ge Healthcare	OMNIPAQUE 140	iohexol	INJECTABLE;INJECTION	018956	NDA	GE Healthcare Inc.	0407-1401-52	10 BOTTLE, PLASTIC in 1 BOX (0407-1401-52) / 50 mL in 1 BOTTLE, PLASTIC	2004-05-25
Ge Healthcare	OMNIPAQUE 140	iohexol	INJECTABLE;INJECTION	018956	NDA	GE Healthcare Inc.	0407-1411-10	10 VIAL, GLASS in 1 BOX (0407-1411-10) / 10 mL in 1 VIAL, GLASS	2004-07-15
Ge Healthcare	OMNIPAQUE 140	iohexol	INJECTABLE;INJECTION	018956	NDA	GE Healthcare Inc.	0407-1412-10	10 VIAL, GLASS in 1 BOX (0407-1412-10) / 10 mL in 1 VIAL, GLASS	1985-12-26
Ge Healthcare	OMNIPAQUE 140	iohexol	INJECTABLE;INJECTION	018956	NDA	GE Healthcare Inc.	0407-1412-20	10 VIAL, GLASS in 1 BOX (0407-1412-20) / 20 mL in 1 VIAL, GLASS	1985-12-26

Iohexol Supply Chain Analysis

Last updated: February 19, 2026

Iohexol, a non-ionic, low-osmolar contrast agent, is critical for diagnostic imaging procedures. Its production relies on a complex global supply chain involving specialized raw material suppliers, active pharmaceutical ingredient (API) manufacturers, and formulation and packaging facilities. Key factors influencing this supply chain include regulatory compliance, manufacturing capacity, intellectual property, and geopolitical stability.

Who are the Primary Manufacturers of Iohexol API?

The global production of iohexol API is concentrated among a limited number of manufacturers, primarily located in Asia and Europe. These companies possess the specialized chemical synthesis capabilities and regulatory approvals required for pharmaceutical-grade API production.

• GE HealthCare: A major player, GE HealthCare manufactures iohexol API through its subsidiary companies. The company has significant global manufacturing capacity and a well-established regulatory track record.
• Lianyungang Oriental Bio-Chem Co., Ltd. (China): This Chinese manufacturer is a significant producer of iodinated contrast media APIs, including iohexol. The company's operations are subject to Chinese regulatory oversight and international pharmaceutical standards.
• Daiichi Sankyo (Japan): While Daiichi Sankyo is primarily known as a finished drug manufacturer, it has historically been involved in the production of contrast agents, potentially including iohexol or its precursors.
• Other API Manufacturers: Several other companies, often less publicly visible, operate in the market, particularly in China and India, producing iohexol API for various markets. These can include contract manufacturing organizations (CMOs) that supply to multiple branded and generic pharmaceutical companies.

The market share for iohexol API production is not publicly disclosed in detail by individual companies. However, industry estimates suggest that GE HealthCare holds a substantial portion of the global market due to its historical dominance in the contrast media sector. Chinese manufacturers, such as Lianyungang Oriental Bio-Chem, have increased their global supply presence over the past decade, driven by competitive pricing and expanding manufacturing capabilities.

What are the Key Raw Materials for Iohexol Synthesis?

The synthesis of iohexol is a multi-step chemical process requiring specific starting materials and intermediates. The availability and quality of these raw materials directly impact the production cost and consistency of the final iohexol API.

• 5-amino-2,4,6-triiodoisophthalic acid: This is a primary precursor for iohexol and other triiodinated contrast agents. Its synthesis involves multiple iodination steps.
• Iodine: As the name suggests, iodine is a fundamental element required for the iodination process. The sourcing and price of iodine, a commodity chemical with limited major producing regions, can influence the overall cost of contrast agents.
• Propylene oxide: Used in the alkylation steps of the synthesis to introduce the characteristic side chains of iohexol.
• Other Reagents and Solvents: Various acids, bases, catalysts, and organic solvents are utilized throughout the multi-step synthesis. The purity of these reagents is critical to avoid impurities in the final API.

The supply chain for these raw materials is global, with significant production of iodine in Chile and Japan, and various chemical intermediates produced by specialty chemical manufacturers worldwide. The reliance on a few key suppliers for certain intermediates can present supply chain risks.

Which Companies Formulate and Package Finished Iohexol Products?

Following the production of iohexol API, it is formulated into sterile injectable solutions and packaged for medical use. This stage involves specialized pharmaceutical manufacturing facilities capable of aseptic processing.

• GE HealthCare: As a vertically integrated company, GE HealthCare manufactures and markets finished iohexol-containing products, such as Omnipaque. Their global network of manufacturing sites ensures widespread distribution.
• Bayer AG: Through its acquisition of entities involved in the contrast media market, Bayer is also a significant producer and marketer of iohexol-based contrast agents.
• Bracco Imaging S.p.A.: A leading company in diagnostic imaging, Bracco manufactures and distributes a range of contrast agents, including those based on iohexol.
• Generic Manufacturers: A growing number of generic pharmaceutical companies globally are entering the iohexol market, particularly in regions with established generic drug manufacturing sectors. These include companies in India, China, and some European countries. Examples include:
  • Intas Pharmaceuticals Ltd. (India)
  • Sun Pharmaceutical Industries Ltd. (India)
  • Various Chinese pharmaceutical companies

These companies source iohexol API from independent API manufacturers and then perform the downstream formulation, filling, and packaging operations. The packaging of iohexol solutions is critical for maintaining sterility and shelf-life, with options including vials, pre-filled syringes, and larger infusion bags.

What are the Regulatory Requirements for Iohexol Production?

The production and distribution of iohexol are subject to stringent regulatory oversight by health authorities worldwide. Compliance ensures product safety, efficacy, and quality.

• Good Manufacturing Practices (GMP): All manufacturing facilities producing iohexol API and finished drug products must adhere to GMP guidelines set forth by regulatory bodies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national agencies. This includes rigorous quality control, process validation, and documentation.
• Drug Master Files (DMFs) / Active Substance Master Files (ASMFs): API manufacturers submit detailed information about their manufacturing process, facilities, and quality controls to regulatory agencies through DMFs (in the US) or ASMFs (in Europe). These files are referenced by finished product applicants during the drug approval process.
• Marketing Authorization Applications (MAAs): Companies seeking to market finished iohexol products must submit comprehensive MAAs to regulatory authorities. These applications include data on the API, finished product formulation, manufacturing, preclinical and clinical studies demonstrating safety and efficacy, and labeling.
• Pharmacopoeial Standards: Iohexol API and finished products must meet the standards defined in official pharmacopoeias, such as the United States Pharmacopeia (USP), the European Pharmacopoeia (Ph. Eur.), and the Japanese Pharmacopoeia (JP). These standards specify identity, purity, assay, and other quality attributes.
• Post-Market Surveillance: Regulatory agencies conduct ongoing surveillance, including facility inspections and review of adverse event reports, to ensure continued compliance and product safety after market approval.

The regulatory landscape can vary by country, necessitating specific submissions and approvals for each target market. This complexity adds significant time and cost to the drug development and commercialization process.

How Does Intellectual Property Affect the Iohexol Market?

The market for iohexol has evolved from a period of strong patent protection for the innovator to one with significant generic competition.

• Original Patents: The initial patents for iohexol, held by companies like Nycomed (later acquired by Takeda and then by GE HealthCare), covered the compound itself and its therapeutic use. These patents provided market exclusivity for a period.
• Exclusivity Periods: Once the primary patents expired, the market opened to generic manufacturers. The duration of market exclusivity varies by country and regulatory framework.
• Process Patents: While the compound itself is off-patent, companies may hold patents on specific innovative manufacturing processes that offer improved efficiency, purity, or cost-effectiveness. These can create barriers to entry for generic competitors seeking to replicate those specific methods.
• Formulation and Delivery Patents: Innovations in the formulation of iohexol (e.g., new excipients, concentration adjustments) or its delivery systems (e.g., specialized syringes) can also be patented, offering further market differentiation.
• Generic Approvals: Generic companies must demonstrate bioequivalence to the reference listed drug (RLD). The approval process for generics involves submitting Abbreviated New Drug Applications (ANDAs) in the US or similar applications in other regions, referencing the original drug's safety and efficacy data.

The interplay of expired compound patents and potential ongoing process or formulation patents influences the competitive dynamics and pricing strategies in the iohexol market. Generic entry typically leads to significant price erosion compared to branded products.

What are the Supply Chain Risks and Mitigation Strategies for Iohexol?

The global nature of the iohexol supply chain presents several potential risks that manufacturers and distributors must manage.

• Geopolitical Instability: Reliance on API manufacturers or raw material suppliers in specific regions can expose the supply chain to disruptions from political unrest, trade disputes, or conflict.
  • Mitigation: Diversifying supplier base across different geographic regions; establishing secondary or tertiary suppliers.
• Raw Material Shortages/Price Volatility: Iodine, a key raw material, is subject to price fluctuations and potential supply constraints. Similarly, availability of specialized chemical intermediates can be affected by production issues at supplier sites.
  • Mitigation: Long-term supply contracts with key raw material providers; maintaining strategic inventory levels of critical raw materials; exploring alternative sourcing options where feasible.
• Regulatory Changes and Compliance Issues: Evolving GMP standards, new environmental regulations, or unexpected import/export restrictions can impact production and distribution.
  • Mitigation: Proactive engagement with regulatory trends; robust internal compliance programs; maintaining open communication channels with regulatory bodies.
• Manufacturing Interruptions: Unforeseen events such as natural disasters, equipment failures, or labor disputes at manufacturing sites can halt production.
  • Mitigation: Redundant manufacturing capabilities (dual sourcing for critical steps); business continuity planning; robust quality management systems to minimize batch failures.
• Logistics and Transportation: Delays in shipping, port congestion, or damage to temperature-sensitive products during transit can affect product availability.
  • Mitigation: Utilizing qualified logistics partners with experience in handling pharmaceuticals; optimizing transportation routes; implementing real-time tracking and monitoring for shipments.
• Quality Control Failures: Batch failures due to contamination or out-of-specification results can lead to product recalls and significant reputational damage.
  • Mitigation: Stringent in-process and final product testing; robust supplier qualification programs; continuous process improvement initiatives.

Companies that have implemented comprehensive supply chain risk management strategies, including dual sourcing, geographical diversification, and proactive regulatory engagement, are better positioned to ensure the consistent availability of iohexol to healthcare providers.

Key Takeaways

The production of iohexol is characterized by a concentrated API manufacturing base, primarily in Asia and Europe, serving a global market of branded and generic finished product manufacturers. Key raw material sourcing, particularly iodine, is critical. Regulatory compliance, including GMP standards and pharmacopoeial requirements, is paramount at all stages. Intellectual property, while largely expired for the compound itself, can still influence market dynamics through process and formulation patents. Supply chain risks, including geopolitical instability, raw material volatility, and manufacturing disruptions, necessitate robust mitigation strategies such as supplier diversification and strategic inventory management.

Frequently Asked Questions

1. What is the primary difference between branded and generic iohexol products? Branded iohexol products, such as Omnipaque, are manufactured by the innovator company or its licensees, who historically held patent protection. Generic iohexol products are manufactured by other companies after the primary patents have expired. Both must meet identical quality, safety, and efficacy standards regulated by authorities like the FDA or EMA, and demonstrate bioequivalence.

2. Are there significant differences in the purity profiles of iohexol APIs from different manufacturers? While all iohexol API manufacturers must meet pharmacopoeial standards for purity, subtle differences in synthesis routes and purification processes can lead to variations in the impurity profiles. Regulatory submissions, such as DMFs, detail these profiles. End-product manufacturers qualify their API suppliers based on these profiles and their impact on the finished product's stability and safety.

3. What is the impact of iodine price fluctuations on the cost of iohexol? Iodine is a key elemental component of iohexol and other iodinated contrast media. Significant volatility in iodine prices, influenced by global supply and demand, can directly impact the cost of raw materials for iohexol API synthesis. Manufacturers may absorb some of these costs, pass them on to customers, or hedge against price increases through long-term contracts.

4. How does the trend towards biosimilars in other therapeutic areas affect the market for generic iohexol? The success and regulatory pathways for biosimilars in biologics do not directly translate to small molecule drugs like iohexol. For iohexol, the market operates under generic drug regulations, not biosimilar pathways. The primary market dynamic is generic entry post-patent expiry, leading to price competition, rather than the development of "biosimilar" versions.

5. What are the typical shelf-life requirements for formulated iohexol solutions, and how do packaging materials influence this? Formulated iohexol solutions typically have shelf lives ranging from 18 months to 3 years, depending on the formulation and packaging. Packaging materials, such as glass vials or specific types of plastic pre-filled syringes, are chosen to prevent leaching, maintain sterility, protect from light (if necessary), and ensure compatibility with the drug product to avoid degradation or loss of efficacy over the intended shelf life.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Guidance for Industry Drug Master Files. Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidance-industry-drug-master-files [2] European Medicines Agency. (n.d.). Active Substance Master File Procedure. Retrieved from https://www.ema.europa.eu/en/human-regulatory/research-and-development/scientific-advice/scientific-advice-medicines/active-substance-master-file-procedure [3] United States Pharmacopeia. (n.d.). General Notices and Chapter Information. Retrieved from https://www.uspharmacopeia.org/ [4] European Pharmacopoeia. (n.d.). Welcome to EDQM. Retrieved from https://www.edqm.eu/en [5] GE HealthCare. (n.d.). Omnipaque. Retrieved from https://www.gehealthcare.com/products/contrast-media/omnipaque [6] Bayer AG. (n.d.). Radiology. Retrieved from https://www.bayer.com/en/us/radiology [7] Bracco Imaging. (n.d.). Products. Retrieved from https://www.bracco.com/en/products/ [8] Lianyungang Oriental Bio-Chem Co., Ltd. (n.d.). Products. (Specific product information often proprietary or found via trade directories). [9] Intas Pharmaceuticals Ltd. (n.d.). Products. (Specific product information often proprietary or found via trade directories). [10] Sun Pharmaceutical Industries Ltd. (n.d.). Products. (Specific product information often proprietary or found via trade directories).