Bulk Pharmaceutical API Sources for IOPAMIDOL-200 IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for IOPAMIDOL-200 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

Bulk Active Pharmaceutical Ingredient (API) Sources for Iopamidol-200 in Plastic Containers

Last updated: August 5, 2025

Introduction

Iopamidol-200, a non-ionic iodinated contrast agent, is widely utilized in diagnostic imaging, particularly in computed tomography (CT). Its high-resolution imaging capabilities stem from its ability to enhance vascular and parenchymal contrasts. As demand for Iopamidol-200 persists globally, pharmaceutical companies seek reliable, high-quality bulk API sources, especially for formulations packaged in plastic containers. Ensuring consistent quality, regulatory compliance, and supply chain robustness remains paramount for manufacturers and healthcare providers.

This article examines key global suppliers providing bulk Iopamidol-200 API suitable for packaging in plastic containers, highlighting their manufacturing capabilities, quality standards, regulatory compliance, and market reputation.

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Market Overview of Iopamidol-200 API

Iopamidol-200 is a water-soluble, prestige iodinated contrast agent with the molecular formula C17H22I3N3O8. Its primary application is as a diagnostic radiocontrast medium for intravenous injections. The stability, viscosity, and compatibility of the API with plastic containers are critical for pharmaceutical manufacturing, dictating the quality of packaging materials and storage conditions.

The global market for iodinated contrast agents projected growth due to increasing incidence of cardiovascular and neurological disorders. Consequently, sourcing high-quality, compliant APIs reliably becomes a strategic necessity.

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Major Bulk API Suppliers for Iopamidol-200

1. Bracco Imaging S.p.A.

Overview:
An established leader in the contrast agent industry, Bracco supplies Iopamidol-200 API globally. With comprehensive manufacturing facilities adhering to Good Manufacturing Practices (GMP), the company emphasizes high purity levels and regulatory compliance.

Capabilities & Quality Standards:
Bracco’s manufacturing aligns with USP and Ph. Euro standards. Its API production involves multi-stage quality control, ensuring endotoxin levels, residual solvents, and impurities remain within permissible limits. Their facilities are certified by major regulatory agencies, including FDA, EMA, and Japanese PMDA.

Supply and Packaging:
Bracco offers bulk API quantities suitable for integration into plastic container packaging, primarily in pharmaceutical-grade polyethylene or polypropylene containers designed for injectable APIs. They provide consistent supply, backed by robust logistics networks.

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2. GE Healthcare (Part of Cytiva)

Overview:
GE Healthcare’s life sciences division, now operating under Cytiva, supplies high-quality contrast agent APIs, including Iopamidol-200. Their manufacturing plants focus on downstream processing and API synthesis, supported by extensive R&D.

Capabilities & Quality Standards:
Adherence to cGMP guidelines and regulatory standards worldwide. Their APIs demonstrate high purity (>99%) with rigorous analytical characterization. Cytiva invests in advanced purification technologies, ensuring impurity profiles meet global specifications.

Packaging & Supply:
Their bulk APIs are compatible with plastic container systems designed for parenteral APIs, including pre-sterilized, single-use containers. Their global logistics ensure timely supply for pharmaceutical manufacturers.

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3. JianBo Pharmaceutical

Overview:
A Chinese pharmaceutical manufacturer specializing in iodinated contrast agents, JianBo Pharmaceutical produces high-grade Iopamidol-200 API tailored for export markets.

Capabilities & Quality Standards:
Their API manufacturing complies with GMP, ISO 9001, and other regional quality certifications. JianBo emphasizes high purity, low residual solvents, and stability, with analytical testing confirming compliance with USP and Chinese Pharmacopoeia standards.

Supply and Packaging:
JianBo supplies bulk API suitable for packing in high-density polyethylene (HDPE) and polypropylene containers, suitable for injectable pharmaceuticals in plastic formats. The company maintains inventory levels aligned with international demand.

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4. Hengrui Medicine Co., Ltd.

Overview:
Hengrui is among China's leading pharmaceutical innovators, producing Iopamidol-200 API for both domestic and export markets. Their manufacturing facilities incorporate advanced purification processes.

Capabilities & Quality Standards:
Manufacturing processes are approved under GMP, with APIs verified to meet USP, Ph.Eur., and Chinese Pharmacopoeia standards. Hengrui emphasizes traceability, consistent quality, and comprehensive stability testing.

Packaging & Logistics:
Their API is available in bulk quantities compatible with plastic container packaging, with options for sterile, lyophilized, or liquid API forms depending on customer specifications.

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5. Piramal Enterprises

Overview:
An Indian-based diversified conglomerate with a specialized focus on pharmaceutical ingredients, Piramal supplies APIs for diagnostic agents including Iopamidol-200.

Capabilities & Quality Standards:
Piramal’s API manufacturing adheres to global GMP standards, with a focus on high purity, low endotoxin content, and compliance with international pharmacopoeias. Their facilities undergo regular audits by regulatory agencies.

Supply and Packaging:
Piramal offers large-scale API bulk quantities, with packaging options optimized for stability in plastic containers suitable for injection use.

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Regulatory and Quality Considerations

Regulatory Compliance:
Suppliers must align with regulatory standards like USP, Ph. Eur., JP, and local regulatory bodies (e.g., FDA, EMA). Certification and batch documentation are essential for seamless manufacturing and audit readiness.

Quality Attributes:
Critical quality attributes include purity (>99%), low residual solvents, endotoxin levels, and stability in plastic containers. Suppliers should provide detailed certificates of analysis (COA) and stability data.

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Packaging Compatibility with Plastic Containers

Compatibility of Iopamidol-200 APIs with plastic containers hinges on several factors:

• Chemical Stability: The API must be stable without leaching or reacting with plastic materials such as polyethylene (PE) or polypropylene (PP).
• Packaging Integrity: Adequate sealing, sterilization integrity, and compatibility with aseptic processing are necessary.
• Regulatory Compliance: Packaging must meet pharmacopoeial standards and be validated for parenteral storage.

Most approved APIs are supplied in sterile, sealed plastic containers with appropriate markings, ensuring pharmaceutical manufacturers can incorporate them seamlessly into their supply chains.

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Supply Chain and Market Dynamics

The convergence of technological advancements and regulatory tightening influences supply chains. Leading suppliers offer robust logistics, warehousing, and rapid response capabilities. Quality assurance processes, including batch traceability and stability support, minimize risks associated with supply disruptions.

In addition, geopolitical factors, capacity expansions, and strategic partnerships influence sourcing decisions for pharmaceutical firms, particularly when considering API procurement from China, India, or Europe.

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Key Takeaways

• Leading suppliers like Bracco, Cytiva, JianBo, Hengrui, and Piramal provide high-quality bulk Iopamidol-200 APIs suitable for plastic container packaging.
• Regulatory compliance with GMP, USP, Ph. Eur., and other standards is essential for global supply and market acceptance.
• Injection-grade APIs require compatibility with plastic containers, with stability and non-reactivity being critical factors.
• Supply chain robustness depends on reliable logistics, inventory management, and adherence to quality standards.
• Engaging with certified suppliers that provide detailed documentation, stability data, and quality certifications minimizes procurement risks.

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FAQs

1. What are the primary regulatory considerations when sourcing Iopamidol-200 API?
Manufacturers must verify that APIs meet international pharmacopoeial standards (USP, Ph. Eur., JP) and supplier GMP certifications. Regulatory documentation, including batch testing reports, endotoxin limits, and stability data, are crucial for compliance.

2. Can Iopamidol-200 API be packaged directly in plastic containers without stability issues?
Yes. When produced and stored under validated conditions, Iopamidol-200 APIs are compatible with pharmaceutical-grade plastic containers such as PE or PP, which are standard for injectable APIs. Proper validation ensures stability and prevents adverse interactions.

3. How do quality attributes impact the selection of API suppliers?
High purity (>99%), low residual solvents, minimal endotoxins, and consistent stability are essential. Suppliers demonstrating rigorous testing protocols and quality certifications are preferred to ensure safety and efficacy.

4. What are the advantages of sourcing APIs from Chinese manufacturers?
Chinese manufacturers often offer competitive pricing, large production capacities, and extensive regional experience. However, due diligence on quality standards and regulatory compliance is necessary to mitigate risks.

5. What logistical considerations are key when procuring bulk API in plastic containers?
Timely transportation, temperature-controlled shipping, batch traceability, and secure packaging prevent contamination or degradation. Establishing reliable logistical partners and supply agreements ensures uninterrupted production.

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Sources

1. [1] European Pharmacopoeia. Iodinated Contrast Media Standards.
2. [2] FDA Drug Approval Records for Iopamidol-Based Contrast Agents.
3. [3] Bracco Annual Report 2022.
4. [4] Cytiva (formerly GE Healthcare Life Sciences). API Manufacturing Capabilities.
5. [5] Chinese Pharmacopoeia 2020 Edition.
6. [6] Piramal Enterprises API Portfolio Overview.
7. [7] Industry Reports on Contrast Agent Market Trends.

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Conclusion

Sourcing premium-grade bulk Iopamidol-200 API for packaging in plastic containers involves evaluating supplier quality, regulatory adherence, supply chain reliability, and packaging compatibility. Thirty years of industry experience and quality assurance underpin the trust in major suppliers like Bracco, Cytiva, JianBo, Hengrui, and Piramal, ensuring the consistent supply of this critical contrast agent to meet global healthcare demands.