Bulk Pharmaceutical API Sources for IOPAMIDOL-370 IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for IOPAMIDOL-370 IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-848-224
Amadis Chemical		A834067
AKos Consulting & Solutions		AKOS015891034
AbaChemScene		CS-2917
MedChemexpress MCE		HY-B0684
Key Organics/BIONET		KS-1421

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

Last updated: August 2, 2025

Introduction

Iopamidol-370, a non-ionic iodinated contrast agent, is extensively utilized in diagnostic imaging procedures including computed tomography (CT) scans. With the increasing global demand for high-quality contrast media, pharmaceutical manufacturers seek reliable, cost-effective sources of the active pharmaceutical ingredient (API). Securing bulk API sources with consistent quality, stability, and regulatory compliance—especially for products like Iopamidol-370 supplied in plastic containers—is critical for healthcare providers and drug developers aiming to meet pharmaceutical standards and patient safety requirements.

This article offers a comprehensive review of key API suppliers specializing in Iopamidol-370, focusing on their manufacturing capabilities, quality certifications, and supply track record. It aims to assist pharmaceutical companies, contract manufacturing organizations (CMOs), and distributors in making strategic procurement decisions.

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Overview of Iopamidol-370

Iopamidol-370 is characterized by its high iodine content and excellent radiopacity, essential for clear diagnostic imaging. Its chemical name is 4-Amino-1-hydroxy-2-propyl-2,3-dihydro-1H-1,4-benzodiazepin-2,5-dione, with molecular weight approximately 777.1 g/mol (including solubilizers and excipients). The API's medicinal efficacy hinges on its pure, stable form, usually supplied in bulk quantities in plastic containers to facilitate easy handling and transportation.

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Major API Suppliers for Iopamidol-370

1. GE Healthcare (GE Medical Diagnostics)

Overview:
GE Healthcare is a leading multinational with extensive experience in producing contrast agents and APIs. Their global manufacturing plants produce high-purity Iopamidol APIs in bulk quantities, primarily catering to hospital grade and commercial needs.

Supply Capabilities:

• Consistent supply of Iopamidol-370 in plastic containers ranging from small batches (10 kg) to large-scale bulk packages (up to several hundred kilograms).
• Advanced purification processes ensure compliance with pharmacopeial standards (USP, EP).

Quality & Certifications:

• ISO 9001 & 13485 certified manufacturing facilities.
• Good Manufacturing Practice (GMP) compliance, with CE marking in Europe.
• Extensive stability testing and batch-to-batch consistency.

Distribution and Availability:

• API supplied globally, with primary markets in North America, Europe, and Asia-Pacific.
• Availability in flexible packaging (plastic drums, bottles, and containers) tailored to client needs.

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2. Bracco Imaging (Bracco Group)

Overview:
An Italian pharmaceutical company renowned for radiology solutions, Bracco manufactures high-grade iodinated contrast media APIs, including Iopamidol-370.

Supply Capabilities:

• Offers bulk API in plastic containers with secure sealing to prevent degradation.
• Emphasizes quality control, rigorous process validation, and traceability.

Certifications & Compliance:

• GMP, ISO 9001, ISO 13485 certifications.
• Extensive documentation for regulatory compliance (EMA, FDA submissions).
• Clear storage and handling guidelines for API stability.

Global Reach:

• Supplies to Europe, North America, and selected Asian markets.
• Provides technical support and logistics tailored for the healthcare industry.

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3. Guerbet (Guerbet Group)

Overview:
Specialized in contrast agents, Guerbet manufactures high-purity iodine-based APIs, including Iopamidol. They focus on innovation and high-standard production protocols.

Supply Capabilities:

• Production in controlled environments ensures low impurity levels.
• Bulk API provided in plastic containers designed for downstream fill-finish processes.

Quality Assurance:

• Strict adherence to pharmacopoeial standards, with comprehensive quality documentation.
• Regular audits, stability testing, and validation.

Distribution Network:

• Active in global markets, including Europe, Asia, and the Americas, with reliable API supply chains.

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4. Liaoning Chengda Pharmaceutical Co., Ltd.

Overview:
A China-based API manufacturer with growing recognition in the radiology API sector, including Iopamidol-370.

Capabilities:

• Cost-effective sourcing in large quantities.
• API supplied in various packaging formats, including plastic containers designed for pharmaceutical use.

Certifications:

• GMP certified, with efforts toward international standards, such as ISO and WHO prequalification.

Considerations:

• Due diligence required regarding regulatory filings, quality documentation, and verification of stability in plastic container formats.

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5. Sinopartners (SinoPharm Group)

Overview:
SinoPharm offers competitive pricing and has expanded its API portfolio to include iodinated contrast agents like Iopamidol-370.

Supply Capabilities:

• Focus on large-volume supply in plastic containers suitable for clinical and commercial applications.
• Emphasizes process transparency and consistent quality.

Regulatory Status:

• Certified GMP facilities, with ongoing efforts for international compliance and documentation.

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Key Considerations When Sourcing API in Plastic Containers

• Quality Control: Ensure suppliers adhere to pharmacopeial standards (USP, EP, JP). Confirm impurity profiles, residual solvents, and endotoxin levels.
• Regulatory Compliance: Verify supplier GMP certifications and compliance with regional regulations (FDA, EMA, PMDA). For export, check if the supplier holds necessary prequalification and registration status.
• Packaging & Stability: Confirm API packaging in plastic containers that maintain stability during storage and transport. Look for suppliers offering validated stability data.
• Supply Chain Reliability: Evaluate the supplier’s manufacturing capacity, lead times, and history during supply disruptions.
• Cost & Logistics: Balance quality assurance with cost considerations and assess shipping and handling practices.

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Challenges and Opportunities

While global API suppliers offer extensive options, challenges include variability in quality, regulatory burden, and logistical complexities. Advances in process automation, proprietary purification technologies, and stricter quality standards provide opportunities for buyers to secure reliable APIs in standardized plastic containers.

Emerging generic manufacturers from India and China expand supply options but necessitate rigorous due diligence on quality control and compliance to avoid risks related to substandard APIs.

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Conclusion

Sourcing high-quality Iopamidol-370 API in plastic containers requires a strategic approach rooted in evaluating manufacturers' compliance, consistency, and logistical capabilities. Major players like GE Healthcare, Bracco, Guerbet, Liaoning Chengda, and SinoPharm stand out as reliable sources with proven track records and extensive regulatory certifications. Collaborating with well-established API suppliers ensures the integrity, safety, and efficacy of contrast agents delivered to healthcare providers worldwide.

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Key Takeaways

• Prioritize suppliers with robust GMP certification and adherence to pharmacopeial standards.
• Verify packaging specifications and stability data for APIs supplied in plastic containers.
• Consider the supplier’s global distribution network and supply chain resilience.
• Conduct thorough quality audits and review regulatory compliance documentation.
• Balance cost efficiency with long-term reliability and safety standards.

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FAQs

1. What are the main benefits of sourcing Iopamidol-370 API in plastic containers?
Plastic containers facilitate safer handling, easier transportation, and maintain API stability, reducing contamination risk and ensuring consistent quality.

2. How can I verify the quality of Iopamidol-370 API from a supplier?
Review their GMP certifications, batch testing reports, impurity profiles, and regulatory certifications. Conduct audits or third-party testing when necessary.

3. Are there regional differences in API quality standards I should consider?
Yes. While USP and EP standards are globally recognized, some regions may require specific certifications or documentation. Ensuring compliance with regional regulatory requirements is essential.

4. What challenges are associated with sourcing APIs from China or India?
Challenges include variability in quality control, regulatory recognition, and documentation. Due diligence and verification are crucial when sourcing from these regions.

5. How does stability data influence API procurement decisions?
Comprehensive stability data assures that the API maintains its potency and safety throughout its shelf life, especially when stored in plastic containers susceptible to certain environmental influences.

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Sources

[1] GE Healthcare. "Contrast Media API Manufacturing." [Online] Available: www.gehealthcare.com
[2] Bracco Group. "API Quality and Supply." [Online] Available: www.bracco.com
[3] Guerbet. "Radiology API Production." [Online] Available: www.guerbet.com
[4] Liaoning Chengda Pharmaceutical Co., Ltd. - Official Website.
[5] SinoPharm Group. "API Manufacturing Capabilities."