Bulk Pharmaceutical API Sources for IOPAMIDOL-370

Bulk Pharmaceutical API Sources for IOPAMIDOL-370

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		65492
MolPort		MolPort-003-848-224
ISpharm		I01-8407
ABI Chem		AC1L23CM
ABI Chem		AC1Q4PBP
ChemMol		49424537
Amadis Chemical		A834067

Bulk Active Pharmaceutical Ingredient (API) Sources for Iopamidol-370

Last updated: August 1, 2025

Introduction

Iopamidol-370 is a non-ionic, water-soluble iodinated contrast agent widely utilized in diagnostic imaging modalities such as computed tomography (CT). Its specific formulation possesses an iodine concentration of approximately 370 mg/mL, facilitating high-quality radiographic imaging with reduced osmolality compared to older contrast media. Given the critical need for purity, consistency, and regulatory compliance, sourcing high-quality bulk APIs like Iopamidol-370 is fundamental for pharmaceutical manufacturers. This article offers an authoritative overview of global API suppliers for Iopamidol-370, scrutinizing their manufacturing capabilities, compliance standards, and strategic considerations essential for procurement.

Global API Suppliers for Iopamidol-370

1. Pharmaceutical API Manufacturing Giants

Major pharmaceutical API producers dominate the supply landscape for iodinated contrast agents, leveraging extensive R&D, manufacturing expertise, and stringent quality systems. These companies have established robust supply chains and accreditations to support pharmaceutical clients globally.

1.1 Bracco Imaging

Bracco, headquartered in Italy, is a leading player in contrast media production. Its manufacturing arm produces Iopamidol products compliant with international standards like EMA and FDA. With extensive GMP certification and global distribution channels, Bracco’s APIs and finished products are trusted by healthcare providers globally.[1]

1.2 GE Healthcare (now part of Cytiva)

GE Healthcare historically invested heavily in contrast media manufacturing, including procurement of high-quality APIs for formulations like Iopamidol. Their regional manufacturing facilities adhere to rigorous regulatory standards, offering bulk API supplies tailored for pharmaceutical companies with specific formulation needs.[2]

1.3 Bayer AG

Bayer, a global life sciences leader, manufactures various contrast agents and the corresponding APIs, including Iopamidol. Their APIs meet the strictest quality standards, supported by comprehensive validation and regulatory documentation to facilitate pharma integration.[3]

2. Specialized API Manufacturer Focused on Contrast Media

Several smaller, specialized manufacturers focus exclusively or predominantly on contrast media API production, often offering customizable specifications to fulfill client requirements.

2.1 VIVAPHARM GmbH

Based in Germany, VIVAPHARM produces high-purity, pharmaceutical-grade iodinated contrast agent APIs. Their facilities comply with ICH Q7 standards and have an established track record of supplying APIs for radiologic contrast agents, including Iopamidol-370.[4]

2.2 Seoul Medical Industry (SMI)

South Korean manufacturer SMI has gained recognition for APIs produced under strict GMP conditions, catering to domestic and export markets. They offer Iopamidol API with documentation supporting regulatory submissions in Asia and other regions.[5]

3. Emerging Markets and Regional API Producers

Emerging markets present alternative sources, often with competitive pricing and flexible production throughput. However, due diligence is necessary to verify compliance and quality standards.

3.1 Delhi-based API Suppliers

India hosts numerous API manufacturers with capabilities in iodinated contrast agents. Companies such as Systopic Laboratories have developed infrastructure compliant with Indian GMP regulations, often exporting APIs like Iopamidol-370 to global markets.[6]

3.2 Chinese API Manufacturers

China is a significant player in generic pharmaceutical APIs. Several firms have obtained manufacturing approvals and export licenses for iodinated contrast agents, including Iopamidol. Certification standards vary, necessitating thorough validation before supplier engagement.[7]

4. Supplier Qualification and Due Diligence

When selecting an API source for Iopamidol-370, factors beyond cost include:

• Regulatory Compliance: Confirm ISO, GMP, and regional accreditation standards (FDA, EMA, CFDA).

• Material Specifications: Ensure API purity (>99%), residual solvent levels, and endotoxin content meet pharmacopeial standards.

• Traceability & Documentation: Full batch documentation, analytical methods, and stability data facilitate regulatory approval.

• Production Capacity & Lead Times: Depend on forecasting demand to prevent supply disruptions.

• Quality Agreements & Certifications: Contracts should specify quality, storage conditions, and compliance obligations.

5. Risks and Considerations

Reliance on regional suppliers with varying standards introduces risks such as regulatory non-compliance, inconsistent quality, or supply chain disruptions. Conducting onsite audits, requesting detailed stability and validation data, and verifying certification authenticity are critical steps before procurement.

Conclusion

The sourcing of Iopamidol-370 API requires a meticulous approach, balancing regional availability, quality standards, regulatory compliance, and supplier reliability. Global pharmaceutical leaders like Bracco, GE Healthcare, and Bayer remain premier options, offering high assurance of quality and regulatory adherence. Regional suppliers, particularly from India and China, can serve as cost-effective alternatives, provided stringent due diligence verifies compliance. Aligning procurement strategies with regulatory expectations and supply chain resilience forms the backbone of secure API sourcing success.

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Key Takeaways

• Sourcing high-quality Iopamidol-370 API involves evaluating global leaders and regional manufacturers based on compliance, quality, and capacity.
• Major suppliers like Bracco, GE Healthcare, and Bayer provide reliable APIs with comprehensive documentation supporting regulatory processes.
• Smaller, regional API producers can offer cost advantages but require rigorous validation of quality standards.
• Due diligence, including audits and certification verification, remains essential for minimizing regulatory and supply chain risks.
• Strategic API sourcing underpins the successful manufacturing of high-quality contrast media, directly impacting clinical efficacy and patient safety.

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FAQs

1. How does API purity affect the safety and efficacy of Iopamidol-370?
Higher purity levels (>99%) minimize adverse reactions and enhance imaging quality, ensuring patient safety and compliance with pharmacopeial standards.

2. What are the main regulatory standards for Iopamidol API suppliers?
Suppliers should adhere to Good Manufacturing Practices (GMP), ISO standards, and regional regulations such as FDA, EMA, or CFDA requirements, ensuring quality and traceability.

3. Can regional API manufacturers supply Iopamidol-370 that meets international standards?
Yes, many regional suppliers conform to international standards. Rigorous validation and audits are recommended to confirm compliance before procurement.

4. What logistical considerations influence API sourcing decisions?
Factors include production capacity, lead times, geopolitical stability, export regulations, and supply chain robustness.

5. How can pharmaceutical companies mitigate risks associated with API supply disruptions?
Establishing dual sourcing agreements, maintaining safety stock, and engaging in proactive supply chain monitoring can mitigate risks.

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References

[1] Bracco Imaging. Corporate website. Accessed 2023.
[2] GE Healthcare. Product documentation. 2022.
[3] Bayer AG. Regulatory filings and API manufacturing disclosures. 2022.
[4] VIVAPHARM GmbH. API product datasheet and GMP certification. 2022.
[5] Seoul Medical Industry. API quality standards and certifications. 2022.
[6] Systopic Laboratories. Indian pharmaceutical API registration. 2022.
[7] Chinese API Manufacturers. Export registration documents, 2022.