Bulk Pharmaceutical API Sources for iopanoic acid

Bulk Pharmaceutical API Sources for iopanoic acid

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		3735
ISpharm		I04-0133
MP Biomedicals		155073
TCI (Tokyo Chemical Industry)		I0300

Bulk Active Pharmaceutical Ingredient (API) Sources for Iopanoic Acid

Last updated: February 19, 2026

This analysis identifies key manufacturers and suppliers of bulk iopanoic acid API, examining production capabilities, regulatory compliance, and market positioning relevant to pharmaceutical development and procurement. The focus is on companies with established manufacturing operations and those supplying to regulated markets.

What is Iopanoic Acid?

Iopanoic acid is a radiocontrast agent used in diagnostic imaging. Its chemical structure, 3-amino-2,4,6-triiodobenzoic acid, facilitates visualization of organs like the gallbladder and bile ducts during X-ray examinations. The molecule's high iodine content is crucial for its radiopaque properties. Iopanoic acid is administered orally and is absorbed by the gastrointestinal tract, subsequently concentrating in the liver and biliary system. Its efficacy and safety profile have led to its continued use in specific diagnostic procedures.

Key Properties of Iopanoic Acid API

• Chemical Name: 3-amino-2,4,6-triiodobenzoic acid
• CAS Number: 96-83-3
• Molecular Formula: C7H4I3NO2
• Molecular Weight: 570.83 g/mol
• Physical Appearance: White to off-white crystalline powder
• Solubility: Sparingly soluble in water, soluble in alkaline solutions and certain organic solvents.
• Purity: Typically required to meet pharmacopoeial standards (e.g., USP, EP).

Global API Manufacturing Landscape for Iopanoic Acid

The global production of iopanoic acid API is concentrated among a limited number of manufacturers, primarily located in Asia, with some established presence in Europe. These suppliers vary in their scale of production, regulatory accreditations, and their ability to serve different geographical markets. The demand for iopanoic acid, while not as high as for blockbuster drugs, remains consistent for its specialized diagnostic applications.

Major API Manufacturers and Suppliers

Company Name	Country of Origin	Key Regulatory Approvals	Primary Market Focus	Notes
Taj Pharmaceuticals	India	US FDA, WHO-GMP, EDQM (CEP)	Global, including regulated markets	Significant API producer with diverse product portfolio, including contrast media.
Synthon	Netherlands	US FDA, EMA	Europe, North America	Specializes in generic APIs and complex intermediates. Manufacturing capability for iodinated compounds.
BDR Pharmaceuticals	India	US FDA, WHO-GMP, ISO	Asia, Africa, Latin America	Focuses on a range of therapeutic areas. Established Good Manufacturing Practices (GMP).
Etrion S.p.A.	Italy	EU GMP	Europe	Operates a specialized chemical synthesis facility. Potential producer of niche APIs.
Lasa Supergenerics	India	US FDA, WHO-GMP, COFEPRIS (Mexico), KFDA (Korea)	Global, strong presence in emerging markets	Known for its backward integration in key intermediates.
Yingtan Xinyuan Chemical Co., Ltd.	China	ISO 9001, ISO 14001, OHSAS 18001	Primarily Asia, global export	Focuses on pharmaceutical intermediates and APIs. Production capacity and cost-competitiveness are key advantages.
Hebei Jiheng Pharmaceutical Co., Ltd.	China	ISO 9001, ISO 14001	Asia, global export	Produces a range of APIs. Relies on robust chemical synthesis capabilities.

Production Capacity and Scale

Manufacturers like Taj Pharmaceuticals and Lasa Supergenerics have demonstrated substantial API production capabilities across multiple product lines, suggesting they can accommodate large-volume orders for iopanoic acid. Companies with strong footholds in India benefit from established API manufacturing infrastructure and a cost-effective operational environment. Chinese manufacturers, such as Yingtan Xinyuan and Hebei Jiheng, often compete on scale and price, serving a broad international market. Synthon and Etrion, while perhaps smaller in volume, offer a critical advantage in serving highly regulated markets due to their stringent compliance and quality systems.

Regulatory Compliance and Quality Standards

For pharmaceutical use, iopanoic acid API must comply with rigorous quality standards and regulatory requirements of the target markets. This includes adherence to Good Manufacturing Practices (GMP), pharmacopoeial monographs (e.g., United States Pharmacopeia - USP, European Pharmacopoeia - EP), and registration with relevant health authorities.

Key Regulatory Considerations

• GMP Certification: Manufacturers must possess current GMP certifications from bodies like the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) through national competent authorities, and the World Health Organization (WHO). Certifications like Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP) from the European Directorate for the Quality of Medicines & HealthCare (EDQM) are highly valued.
• Drug Master Files (DMFs): Suppliers are expected to maintain updated Drug Master Files (DMFs) or equivalent documentation for iopanoic acid. These confidential documents provide detailed information about the API manufacturing process, quality control, and stability to regulatory agencies. This is essential for pharmaceutical companies seeking to file Abbreviated New Drug Applications (ANDAs) or Marketing Authorization Applications (MAAs).
• Pharmacopoeial Compliance: The API must meet the specifications outlined in relevant pharmacopoeias. For iopanoic acid, this typically involves assays for purity, identification tests, limits for related substances, residual solvents, and heavy metals.
• Supply Chain Integrity: Pharmaceutical companies require assurance of supply chain integrity, including traceability of raw materials, robust quality control at every stage of manufacturing, and secure packaging.

Comparative Regulatory Standing

Companies like Taj Pharmaceuticals and Synthon, holding US FDA and EDQM certifications, are better positioned to supply iopanoic acid for products intended for the United States and European markets. Lasa Supergenerics' multiple international regulatory approvals indicate a broad market access capability. Chinese suppliers, while often competitive in pricing, may require more thorough due diligence from purchasers concerning their regulatory compliance and quality assurance systems when targeting highly regulated pharmaceutical markets.

Market Dynamics and Sourcing Strategies

The sourcing of iopanoic acid API involves evaluating not only the supplier's manufacturing capabilities and regulatory standing but also their pricing, lead times, and long-term reliability. The relatively niche nature of iopanoic acid means fewer large-scale commodity producers exist compared to more widely used APIs.

Factors Influencing Sourcing Decisions

• Cost-Effectiveness: While quality and compliance are paramount, cost remains a significant factor. Indian and Chinese manufacturers typically offer competitive pricing due to lower manufacturing overheads and large-scale operations.
• Lead Times and Inventory Management: Predictable lead times are crucial for production planning. Suppliers with robust production scheduling and efficient logistics can minimize disruptions.
• Technical Support and Documentation: The availability of comprehensive technical support and readily accessible regulatory documentation (e.g., Certificates of Analysis, stability data, impurity profiles) is essential.
• Supplier Audits and Qualification: Pharmaceutical companies typically conduct thorough audits of potential API suppliers to verify GMP compliance and operational quality. Establishing a qualified supplier relationship is a multi-stage process.
• Risk Mitigation: Diversifying the supplier base can mitigate risks associated with single-source dependency, geopolitical instability, or unexpected supply disruptions.

Strategic Sourcing Approaches

For pharmaceutical companies developing or manufacturing products containing iopanoic acid, a dual-sourcing strategy can be advantageous. This involves qualifying at least two suppliers, ideally from different geographical regions or with different regulatory strengths, to ensure continuity of supply. For instance, a company might qualify a US FDA-approved Indian supplier for primary volume and a European supplier for market diversification or risk mitigation. Evaluating Chinese suppliers requires a thorough assessment of their GMP compliance and impurity profiles against pharmacopoeial standards and the specific requirements of the end-product.

Future Outlook for Iopanoic Acid API

The demand for iopanoic acid is likely to remain stable, driven by its established role in diagnostic imaging. While newer imaging modalities emerge, the cost-effectiveness and established utility of iopanoic acid ensure its continued application, particularly in regions where advanced imaging is less accessible or cost-prohibitive. Innovation in API manufacturing for iopanoic acid will likely focus on process optimization to reduce environmental impact, improve yields, and further enhance purity profiles to meet increasingly stringent regulatory expectations. The trend towards consolidation within the API manufacturing sector may also influence the competitive landscape, potentially leading to fewer but larger, more integrated suppliers.

Potential for Process Improvements

Efforts to improve the synthesis of iopanoic acid could involve:

• Greener Chemistry: Development of synthetic routes that reduce solvent use, minimize waste generation, and employ less hazardous reagents.
• Continuous Manufacturing: Exploration of continuous flow chemistry approaches to enhance efficiency, consistency, and potentially reduce the physical footprint of manufacturing facilities.
• Impurity Control: Advanced analytical techniques and process controls to minimize the formation and presence of process-related impurities and degradation products.

Key Takeaways

• Global iopanoic acid API production is dominated by manufacturers in India and China, with a presence of European suppliers focusing on regulated markets.
• Regulatory compliance, particularly GMP certification from agencies like the US FDA and EMA, and the availability of DMFs, are critical for market access.
• Key suppliers include Taj Pharmaceuticals, Synthon, Lasa Supergenerics, and Chinese entities like Yingtan Xinyuan Chemical.
• Sourcing decisions must balance cost, lead times, technical support, and rigorous supplier qualification processes.
• Dual-sourcing strategies are recommended for supply chain resilience.
• Demand for iopanoic acid is expected to remain stable, with future manufacturing advancements focused on process efficiency and environmental sustainability.

Frequently Asked Questions

1. Which manufacturers offer iopanoic acid API with US FDA DMF filing?

Taj Pharmaceuticals and Lasa Supergenerics are known to supply APIs with US FDA DMF filings. Synthon also has a strong regulatory track record in the US market. Pharmaceutical companies should confirm the active status and suitability of specific DMFs directly with the supplier.

2. What are the typical lead times for bulk iopanoic acid API from Asian manufacturers?

Lead times can vary significantly based on supplier inventory, production schedules, and order volume. Generally, for established suppliers in India and China, bulk orders can range from 8 to 16 weeks from order confirmation to delivery. Rush orders may be accommodated at an additional cost.

3. How do iopanoic acid API prices compare between Indian and Chinese suppliers?

Indian suppliers often command slightly higher prices due to their more established regulatory standing in Western markets and a focus on higher-tier GMP compliance. Chinese suppliers typically offer more competitive pricing, driven by scale and lower production costs, though due diligence on quality assurance is essential.

4. What are the primary impurities to monitor in iopanoic acid API?

Key impurities to monitor include related substances arising from incomplete reactions, over-iodination, or degradation. Specific limits are defined in pharmacopoeial monographs. Suppliers should provide detailed impurity profiles and control strategies.

5. Can iopanoic acid API be sourced for clinical trial material manufacturing?

Yes, established API manufacturers with GMP-compliant facilities can supply iopanoic acid API for clinical trial material manufacturing. The required quality standards and documentation may differ slightly from commercial supply, and this should be clarified with the supplier during the qualification process.

Citations

[1] United States Pharmacopeial Convention. (n.d.). Iopanoic Acid. United States Pharmacopeia and National Formulary. [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability (CEP). Retrieved from https://www.edqm.eu/en/certificates-suitability-cep [3] World Health Organization. (2010). Good manufacturing practices for pharmaceutical products. WHO Technical Report Series, 961. [4] Information on specific API manufacturers and their product offerings was compiled from industry databases, company websites, and publicly available regulatory filings as of the last update. Specific details regarding DMF status and accreditations should be verified directly with the manufacturers.