Bulk Pharmaceutical API Sources for TELEPAQUE

Bulk Pharmaceutical API Sources for TELEPAQUE

Vendor	Vendor Homepage	Vendor Sku	API Url
TCI (Tokyo Chemical Industry)		I0300
Molport		MolPort-003-666-506
Amadis Chemical		A845646
AKos Consulting & Solutions		AKOS015854598
Finetech Industry Limited		FT-0631496

Bulk Active Pharmaceutical Ingredient (API) Sources for TEPAQUE

Last updated: July 30, 2025

Introduction

TEPAQUE, known chemically as sodium iothalamate, is a radiocontrast agent primarily utilized in imaging procedures such as angiography, venography, and nephrograms. Its pharmacological role hinges on its high iodine content, which enhances X-ray imaging for diagnostic purposes. The effective production of TEPAQUE depends on sourcing high-quality sodium iothalamate, the active pharmaceutical ingredient (API). Navigating the landscape of API suppliers is pivotal for pharmaceutical manufacturers aiming to ensure consistent product quality, regulatory compliance, and cost competitiveness.

Market Overview of Sodium Iothalamate (API)

Sodium iothalamate is a complex, iodine-based contrast medium synthesized through a multistep chemical process involving electrophilic substitution, iodination, and purification stages. Its production demands stringent control over impurity profiles, residual solvents, and particle specifications. The global market for iodine-based contrast agents is dominated by a handful of specialized API manufacturers capable of delivering pharmacopoeia-compliant ingredients at scale.

Key API Suppliers for TEPAQUE

Several API manufacturers serve the demand for sodium iothalamate, often integrated within larger pharmaceutical groups or specialized chemical suppliers. These producers are distinguished by their manufacturing capabilities, regulatory track record, and geographic presence.

1. Bracco Imaging

Bracco, headquartered in Italy, is a major player in the contrast media industry. The company’s extensive R&D and manufacturing infrastructure support the production of high-purity sodium iothalamate. Bracco's API quality standards align with FDA and EMA regulations, facilitating global distribution of finished TEPAQUE products. Their capability includes tailored supply agreements, ensuring stable supply chains.

2. GE Healthcare (now part of GE HealthCare)

GE Healthcare historically developed its own contrast media formulations, sourcing sodium iothalamate from certified API suppliers. While primarily a finished product provider, GE’s collaboration with select API manufacturers ensures high-quality ingredients used in their contrast agents. Their in-house quality assurance underscores supply chain reliability for critical APIs.

3. Guerbet Group

Guerbet, based in France, manufactures medical imaging contrast media, relying on globally sourced sodium iothalamate APIs. The company maintains strict quality standards, partnering with API producers who meet pharmacopeial specifications. Guerbet emphasizes regulatory compliance and supply stability for their contrast agents, including TEPAQUE.

4. Iodine Producers and Specialty Chemical Suppliers

Several specialized chemical companies supply the iodine moiety critical for synthesizing sodium iothalamate:

• ICL (Israel Chemicals Ltd.) – One of the world's leading producers of iodine derivatives, providing raw iodine used in contrast agent synthesis.
• FMC Corporation – Offers highly purified iodine reagents utilized in pharmaceutical synthesis.
• Nippon Iodine Industry Co., Ltd. – Supplies iodine and related compounds with high purity standards.

These companies supply raw iodine or iodine derivatives to pharmaceutical manufacturers who produce sodium iothalamate API. Their role is critical in ensuring purity levels compatible with injectable pharmaceutical products.

5. Contract Manufacturing Organizations (CMOs)

There are specialized CMOs that produce sodium iothalamate API under strict contract, often catering to multiple pharmaceutical companies. These organizations invest in state-of-the-art synthesis and purification facilities to uphold regulatory standards. Examples include:

• BASF (via custom synthesis services)
• Lonza

Their offerings often include development, scale-up, and supply of sodium iothalamate APIs tailored to client specifications.

Regulatory Considerations and Quality Standards

Manufacturers sourcing sodium iothalamate API must ensure compliance with pharmacopoeial standards, such as USP, Ph. Eur., or JP, with specific attention to iodine content, residual solvents, and impurities (e.g., unreacted intermediates). GxP compliance, validation records, and capacity for batch-to-batch consistency are prerequisites for reputable suppliers.

Current Supply Chain Challenges

Recent disruptions—caused by geopolitical tensions, global supply constraints, and raw material shortages—have impacted API availability. The iodine supply chain, in particular, faces challenges related to sulfuric acid and other reagents used in iodine extraction, affecting downstream API production. Companies should evaluate supplier resilience, geographic diversification, and contingency planning.

Strategic Sourcing Considerations

For firms manufacturing TEPAQUE, prudent API sourcing involves:

• Partnering with recognized, regulatory-compliant suppliers.
• Verifying consistency through site audits and quality documentation.
• Maintaining multiple supplier relationships to mitigate supply risks.
• Monitoring global iodine market fluctuations affecting API pricing and availability.

Emerging Trends and Future Outlook

The industry is witnessing advancements in synthesis techniques, including greener protocols and process intensification, to stabilize supply and reduce costs. There is also growing interest in developing alternative contrast agents potentially requiring different APIs, which may influence the sodium iothalamate market dynamics.

Additionally, supply chain localization efforts and increased regulatory scrutiny necessitate closer supplier integration and validation processes.

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Key Takeaways

• Leading API suppliers such as Bracco, Guerbet, and regional iodine producers ensure high-quality sodium iothalamate for TEPAQUE manufacturing.
• Quality assurance and regulatory compliance are critical in API selection, with pharmacopoeial standards serving as benchmarks.
• Supply chain resilience remains a concern due to raw material shortages and geopolitical factors; diversification strategies are essential.
• Emerging synthesis innovations could reshape sourcing dynamics by offering more sustainable or cost-effective API production methods.
• Proactive supplier engagement and strategic planning enable consistent API availability, ensuring uninterrupted supply of TEPAQUE.

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FAQs

1. Are all sodium iothalamate APIs equivalent in quality?
No. Regulatory standards such as USP or Ph. Eur. establish purity, iodine content, and impurity limits. Vendors must demonstrate compliance to these standards through rigorous testing and documentation.

2. How does iodine supply affect sodium iothalamate API production?
Iodine is a critical raw material; fluctuations in iodine availability and price directly impact the cost and capacity of sodium iothalamate manufacturing.

3. What regulatory considerations are essential when sourcing API for TEPAQUE?
Manufacturers must verify that suppliers comply with GMP, provide batch documentation, and meet pharmacopeial standards. Regulatory audits and supplier qualification are vital.

4. Can alternative suppliers provide cost advantages?
Potentially, but cost savings must not compromise quality, compliance, or supply security. Due diligence is crucial before transitioning suppliers.

5. How might future innovations impact API sourcing for contrast agents?
Advances in synthetic processes or new contrast materials could diminish reliance on traditional iodine-based APIs, altering the procurement landscape.

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References

[1] European Pharmacopoeia, Sodium Iothalamate Monograph.
[2] USP National Formulary, Contrast Media API Standards.
[3] Iodine Market Review, Iodine Producers Association, 2022.
[4] Global Supply Chain Disruptions in Pharmaceutical APIs, WHO Reports, 2023.
[5] Industry Reports on Contrast Media Manufacturing, MedTech Insights, 2022.