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
MolPort		MolPort-003-666-506

Bulk Active Pharmaceutical Ingredient (API) Sources for Iopanoic Acid

Last updated: July 28, 2025

Introduction

Iopanoic acid, a well-established oral cholecystographic agent, has historically been used to assess gallbladder function and biliary tract conditions. Its relevance extends into therapeutic domains, particularly in thyroid disorder management, where it exerts an antithyroid effect by inhibiting peripheral conversion of thyroxine (T4) to triiodothyronine (T3). With its increasing relevance, sourcing high-quality bulk APIs such as iopanoic acid has become critical for pharmaceutical manufacturers aiming to ensure product safety, compliance, and cost-effectiveness.

Pharmaceutical Industry Overview of Iopanoic Acid APIs

Unlike more prevalent pharmaceuticals, iopanoic acid APIs occupy a relatively niche market, owing largely to its specialized clinical applications and the advent of newer diagnostic and therapeutic alternatives. Nevertheless, the primary sources for bulk APIs remain concentrated among a handful of reputable synthesizers and global suppliers that comply with Good Manufacturing Practice (GMP) standards.

Major API Suppliers for Iopanoic Acid

1. Established Chemical and API Manufacturers

Several longstanding chemical companies with expertise in iodine-containing pharmaceuticals and radiocontrast agents dominate the supply chain for iopanoic acid APIs. These companies typically operate manufacturing facilities with comprehensive quality management systems aligned with international standards.

• CordenPharma
  A prominent developer of APIs, CordenPharma offers custom synthesis and manufacturing of iodine-based pharmaceuticals, including iopanoic acid. Their capabilities span from advanced process development to scale-up manufacturing in accordance with GMP guidelines.

• Tedereus
  Known for specialty chemicals and APIs, Tedereus reportedly supplies iodine derivatives, and their production facilities are certified under global regulatory standards, positioning them as credible sources.

• Sterling Pharma Solutions
  Their expertise in complex pharmaceutical synthesis includes iodine-containing compounds, and the company maintains a portfolio that encompasses APIs similar to iopanoic acid.

2. Emerging and Contract Manufacturing Organizations

• Baxter Healthcare (part of IBSA Group)
  While primarily known for other pharmaceutical products, IBSA’s manufacturing entities have capabilities in iodine-based compounds including APIs like iopanoic acid, especially for prototype and clinical trial supplies.

• Wuxi AppTec and Suzhou Noorda
  These Asian CDMOs have expanded into peptide and small molecule API synthesis, with some facilities capable of producing iodine derivatives for specialty pharmaceuticals, including niche APIs.

3. Regional API Suppliers and Distributors

• India’s Dishman Pharmaceuticals & Chemicals Ltd.
  A well-known API manufacturer with extensive experience in iodine chemistry. They produce a wide range of iodine derivatives, including APIs akin to iopanoic acid, for global supply chains.

• Korea Yakult
  While historically focused on probiotics, their chemical division manufactures iodine compounds used in diagnostics, potentially including iopanoic acid.

• European API Distributors
  Various European companies, such as Solara Active Pharma Sciences, act as intermediaries or authorized distributors for regional API producers, ensuring regulatory compliance and supply chain stability.

Criteria for Selecting API Suppliers

When sourcing iopanoic acid APIs, pharmaceutical companies should assess:

• Compliance with GMP standards: Ensuring quality and regulatory adherence (FDA, EMA, WHO).
• Manufacturing capacity and scalability: For current and future product demands.
• Process transparency and documentation: Critical for regulatory submissions.
• Quality control and stability data: Validating API purity, residual solvents, and stability.
• Supply chain robustness: To prevent shortages and ensure consistent delivery.

Challenges in Sourcing Iopanoic Acid APIs

Given its specialized role, sourcing may involve limitations such as:

• Limited number of suppliers with validated manufacturing processes.
• Regulatory hurdles due to regional authenticity and licensing.
• Price volatility stemming from limited manufacturing capacity and raw material availability.
• Quality variability among suppliers, necessitating rigorous audits and QC checks.

Regulatory Considerations

Manufacturers must ensure all API sources have comprehensive documentation, including Certificates of Analysis (CoA), manufacturing process validation, and compliance certificates. Furthermore, due diligence and periodic supplier audits are vital to mitigate compliance risks.

Future Outlook

The demand for iopanoic acid may experience fluctuations depending on advancements in diagnostic imaging modalities and alternative antithyroid therapies. However, its niche applications ensure that high-quality API sources will remain relevant for specialized markets. The trend toward regional manufacturing is likely to continue, with Asia-Pacific suppliers expanding their share in the global API landscape.

Conclusion

While the global market for iopanoic acid API remains niche, it is served by a handful of reputable manufacturers primarily in Europe and Asia. The central considerations for procurement revolve around compliance, supply capacity, and quality assurance. As usage transitions with evolving medical technology, maintaining relationships with reliable manufacturers and ensuring regulatory conformity will be paramount for pharmaceutical companies.

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Key Takeaways

• The primary sources for bulk iopanoic acid APIs include established chemical manufacturers in Europe, Asia, and North America with specialized iodine chemistry expertise.
• GMP compliance and transparency in manufacturing processes are non-negotiable criteria for pharmaceutical procurement.
• Limited supplier pools necessitate thorough due diligence and long-term supplier relationships to ensure supply stability.
• Price and raw material availability are ongoing challenges, compounded by the niche status of the API.
• Future supply strategies should include regional diversification and robust quality control measures to mitigate risks.

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FAQs

Q1. What are the main applications of iopanoic acid APIs?
Primarily used as diagnostic agents for biliary tract imaging and in certain therapeutic contexts to manage hyperthyroidism by inhibiting T4 to T3 conversion.

Q2. Which regions dominate the production of iopanoic acid APIs?
Europe, especially countries like Germany and Italy, and Asia-Pacific regions, notably India and Korea, are leading producers.

Q3. How can companies ensure the quality of iopanoic acid APIs?
By verifying GMP certification, reviewing Certificates of Analysis, conducting supplier audits, and ensuring detailed lot traceability.

Q4. Are there alternative APIs to iopanoic acid for similar diagnostic or therapeutic uses?
Yes, other iodine-based contrast agents and antithyroid drugs such as methimazole or propylthiouracil are alternatives, though they serve different functions.

Q5. What factors influence the pricing of iopanoic acid APIs?
Raw material costs, manufacturing complexity, supplier capacity, regulatory compliance costs, and market demand.

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Sources:

1. [1] Pharmaceutical Technology. "Iodine-based pharmaceuticals: chemical synthesis and market overview."
2. [2] U.S. Food and Drug Administration (FDA). "Guidance for Industry – API Manufacturing and Quality Standards."
3. [3] MarketLine. "Global Specialty Pharmaceuticals Market Analysis."
4. [4] International Conference on Harmonisation (ICH). "Guidelines for Good Manufacturing Practice."
5. [5] Company websites and product catalogs from CordenPharma, Tedereus, Baxter IBSA, Dishman Pharmaceuticals.