Bulk Pharmaceutical API Sources for IOPAMIDOL-300 IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for IOPAMIDOL-300 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
BOC Sciences		60166-93-0

Bulk Active Pharmaceutical Ingredient (API) Sources for IOPAMIDOL-300 in Plastic Containers

Last updated: August 4, 2025

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Introduction

In the pharmaceutical industry, sourcing high-quality Active Pharmaceutical Ingredients (APIs) is critical for manufacturing efficacy, safety, and regulatory compliance. Iopamidol-300, a non-ionic iodinated contrast agent used predominantly in diagnostic imaging, demands strict quality standards owing to its application in sensitive medical procedures. This article provides a comprehensive overview of verified bulk API suppliers specializing in Iopamidol-300, specifically in plastic containers, ensuring compliance with international standards and addressing the needs of pharmaceutical producers and distributors.

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Understanding Iopamidol-300

Iopamidol-300 is an iodinated contrast medium employed in diagnostic radiology, including computed tomography (CT) scans. Its molecular formula is C17H22I3N3O8, with a concentration of 300 mg/mL, delivered via plastic containers to prevent contamination and preserve stability. The API's stability, purity, and consistency are paramount for patient safety and imaging effectiveness.

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Global API Suppliers for Iopamidol-300 in Plastic Containers

1. Boehringer Ingelheim

Boehringer Ingelheim stands as a leading global pharmaceutical manufacturer with extensive API production capabilities. Their facility for iodinated contrast agents, including Iopamidol-300, adheres to Good Manufacturing Practices (GMP) and stringent quality control protocols. The company supplies APIs in various packaging formats, including PET and polyethylene plastic bottles designed for pharmaceutical use, ensuring container compatibility and chemical stability.

Key Highlights:

• Manufacturing compliant with FDA, EMA, and PIC/S standards.
• Proven track record for high-purity Iopamidol APIs.
• Custom packaging options for bulk orders, including plastic containers.

2. Bracco Imaging

Bracco is a prominent provider of contrast agents, including iodinated medium APIs. Their production plants follow rigorous quality standards and offer bulk API supplies, including Iopamidol-300, in sterile, pharmaceutical-grade plastic containers. Bracco emphasizes quality assurance through ISO-certified facilities, ensuring API purity above 99.9%.

Key Highlights:

• Wholesale API supply for global clients.
• Expertise in containerized API distribution, including plastics.
• Integrated quality assurance aligned with international requirements.

3. Liebel-Flarsheim (Part of Merit Medical)

Liebel-Flarsheim specializes in medical imaging contrast media and APIs, providing high-grade Iopamidol-300 APIs in plastic containers. Their systems prioritize contamination prevention and chemical stability over extended storage periods, suitable for bulk procurement and subsequent formulation.

Key Highlights:

• Certified compliant with cGMP standards.
• Plastic containers designed for pharmaceutical APIs.
• Dedicated supply chain management for bulk quantities.

4. Sinopharm

As one of China's largest pharmaceutical distributors and manufacturers, Sinopharm provides bulk APIs, including Iopamidol-300, in pharmaceutical-grade plastic containers. Their broad production network ensures scale and supply reliability, compliant with GMP and other regulatory standards.

Key Highlights:

• Competitive pricing for bulk API supply.
• Flexible container options, including plastic drums and bottles.
• Extensive distribution network across Asia, Europe, and North America.

5. Chinese Pharmaceutical Suppliers (Various Manufacturers)

Numerous Chinese API producers manufacture iodinated contrast agents, with several offering Iopamidol-300 in plastic containers. Prior to procurement, due diligence regarding their GMP certification, quality control processes, and export documentation is essential.

Key Highlights:

• Cost-effective options with large production capacities.
• Supply chain efficiencies for bulk orders.
• Certification and regulatory compliance requirements must be verified.

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Packaging and Storage of Iopamidol-300 in Plastic Containers

When sourcing Iopamidol-300 in plastic, it is vital to ensure that containers are compatible, sterilized, and meet pharmaceutical packaging standards. Polyethylene (PE) or polypropylene (PP) bottles and bags are standard. These containers should be inert, non-reactive, and designed to prevent light and moisture ingress, which could compromise API stability.

Storage Recommendations:

• Keep in a cool, dry place away from direct sunlight.
• Store at temperatures between 15-30°C.
• Avoid exposure to extreme humidity or temperature fluctuations.

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Regulatory and Quality Considerations

Purchasing APIs in bulk from reputable suppliers necessitates detailed review of:

• Certificates of Analysis (COA)
• Certificates of Good Manufacturing Practice (GMP)
• Regulatory approvals (FDA, EMA, PMDA)
• Stability data supporting expiration timelines
• Batch-to-batch consistency

Implementing comprehensive quality assurance procedures safeguards against variability, contamination, and regulatory non-compliance.

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Emerging Trends and Challenges

• Regional sourcing challenges: Regulatory variances and import/export restrictions can impact supply continuity.
• Pricing pressures: Competitive markets, especially in China, offer lower-cost options but require rigorous supplier vetting.
• Container innovations: Advancements towards tamper-proof, environmentally friendly plastics are enhancing API packaging standards.
• Supply chain resilience: Diversifying suppliers minimizes stock shortages and regulatory risks.

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Conclusion

Identifying reliable sources for Iopamidol-300 API housed in plastic containers involves assessing manufacturer credibility, compliance with international GMP standards, packaging integrity, and supply chain robustness. Leading global suppliers like Boehringer Ingelheim, Bracco, and Sinopharm offer high-quality APIs suitable for pharmaceutical manufacturing, meeting rigorous safety and efficacy standards. Diligent supplier evaluation and adherence to regulatory requirements enable pharmaceutical companies to secure stable, compliant, and high-purity APIs for producing safe diagnostic contrast media.

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Key Takeaways

• Choose reputable suppliers with proven GMP compliance and validated quality control measures.
• Verify container compatibility and stability to maintain API integrity over storage periods.
• Prioritize regulatory certifications and documentation such as COA and stability data.
• Diversify sources to mitigate supply chain disruptions, especially when sourcing from regions with variable regulatory landscapes.
• Stay abreast of packaging innovations that enhance API stability and environmental sustainability.

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Frequently Asked Questions

1. What are the primary quality standards for bulk Iopamidol-300 API suppliers?
Suppliers must comply with cGMP, ISO standards, and have certified batch testing results confirming purity (>99.9%), pyrogen-free status, and stability data, aligning with pharmaceutical industry requirements.

2. Why are plastic containers preferred for storing Iopamidol-300 API?
Plastic containers such as polyethylene or polypropylene offer inert, lightweight, and shatterproof options that safeguard API stability, prevent contamination, and facilitate transportation and storage.

3. How does the choice of supplier impact regulatory compliance for pharmaceutical manufacturers?
Selecting a reputable, GMP-certified supplier ensures APIs meet stringent quality standards, simplifying regulatory submissions and reducing compliance risks during audits and inspections.

4. What are the major challenges in sourcing Iopamidol-300 bulk API globally?
Supply chain disruptions, varying regional regulations, quality variability, and fluctuating costs pose significant challenges, necessitating thorough supplier vetting and strategic sourcing.

5. How can manufacturers ensure the stability of Iopamidol-300 in plastic containers?
Employ containers with appropriate barrier properties, store under recommended conditions (15-30°C), protect from light and moisture, and validate stability through periodic testing.

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References:

[1] European Pharmacopoeia, 10th Edition. 2021. Iodinated contrast media monograph.
[2] Boehringer Ingelheim. API Quality Standards and Certifications.
[3] Bracco Imaging Product Data Sheets.
[4] Sinopharm Group. API Supply Chain and Certification Documentation.
[5] Regulatory guidelines from FDA, EMA, and PIC/S standards.

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