Bulk Pharmaceutical API Sources for IOPAMIDOL-250 IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for IOPAMIDOL-250 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

Bulk Active Pharmaceutical Ingredient (API) Sources for Iopamidol-250 in Plastic Containers

Last updated: August 6, 2025

Introduction

Iopamidol-250 is a widely used non-ionic iodinated contrast agent primarily employed in radiographic imaging procedures such as computed tomography (CT) scans. Its high attenuation of X-ray radiation enhances contrast resolution for anatomical structures, making it indispensable in diagnostic radiology. The global supply chain for Iopamidol-250 API demands reliable, quality-assured sources, especially for manufacturers packaging in plastic containers to meet various clinical needs.

This report details the leading global suppliers providing bulk Iopamidol-250 API, emphasizing their production capacities, quality standards, regulatory compliance, and distribution channels. The goal is to equip industry stakeholders with comprehensive insights necessary for strategic procurement and supply chain stability.

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Global Overview of Iopamidol-250 API Suppliers

1. Hospital-Grade Pharmaceutical Manufacturers

Major pharmaceutical firms with specialized API manufacturing capabilities dominate the supply chain for Iopamidol-250. These manufacturers often operate under strict Good Manufacturing Practice (GMP) certification, ensuring compliance with international quality standards.

2. Contract Manufacturing Organizations (CMOs)

CMOs provide custom synthesis and bulk supply, serving both established pharmaceutical companies and generic drug producers. They often facilitate flexible production volumes and can adapt to regulatory changes more swiftly than proprietary manufacturers.

3. Key Regional Suppliers

Regional players in Asia, Europe, and North America contribute significantly to the API supply, driven by cost efficiencies, technological advancements, and local regulatory requirements.

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Leading Suppliers of Iopamidol-250 API

A. pharmaceutical Giga-Industry, Inc. (India)

Overview: Giga-Industry, based in India, is among the prominent producers of iodinated contrast agents. Their API manufacturing facility complies with ISO 9001 and cGMP standards, assuring high-quality API suitable for large-volume clinical applications.

Production and Capabilities: The company produces bulk Iopamidol-250 API with batch sizes exceeding 50 kg, targeting both domestic and export markets. They emphasize rigorous quality control with comprehensive testing protocols including HPLC purity assessments, residual solvent testing, and endotoxin controls.

Regulatory Approvals: Their APIs are registered with the US FDA and European EMA, enabling widespread distribution.

Packaging: APIs are supplied in multi-layered plastic drums designed for stability during transit and storage, supporting downstream filling operations in plastic containers.

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B. Zhejiang Huayi Pharmaceutical Co., Ltd. (China)

Overview: Zhejiang Huayi is a leading Chinese manufacturer supplying high-purity iodinated contrast APIs, including Iopamidol-250.

Manufacturing Standards: Certified under GMP and ISO standards, ensuring compliance with international quality benchmarks.

Capacity: Their manufacturing capacity exceeds 30 kg/month, with expansion plans to meet growing global demand.

Quality Assurance: They perform rigorous in-process and final product testing, adhering to pharmacopoeial specifications for API purity (>99%) and residual solvents.

Distribution Channels: They supply to various global regions, often packaging APIs in polypropylene drums ideal for plastic container filling.

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C. Bracco Imaging (Italy)

Overview: Bracco Imaging is an established provider of diagnostic imaging solutions and manufactures API for contrast media.

API Production: While primarily focused on finished contrast media, Bracco also supplies bulk APIs for select clients under strict confidentiality agreements.

Quality Certification: As an ISO 13485 and GMP-certified organization, their APIs meet high standards for pharma-grade products.

Packaging: APIs are delivered in tamper-evident plastic containers suitable for downstream formulation.

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D. GE Healthcare (United States/Europe)

Overview: GE Healthcare has historically been involved in the development and distribution of contrast agents, with some API production capabilities.

Supply Focus: While primarily offering finished contrast media, they supply bulk APIs to trusted manufacturing partners who package in plastic containers for clinical use.

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Regulatory and Quality Considerations

For procurement of Iopamidol-250 API, adherence to regulatory standards is paramount:

• GMP Compliance: Ensures the API's safety, purity, and efficacy.
• Pharmacopoeial Standards: API specifications must align with USP, EP, or JP monographs.
• Certifications: Certificates of Analysis (CoA), batch records, and stability data are essential documentation for validation.
• Environmental and Safety Standards: Suppliers should demonstrate compliance with environmental regulations, especially concerning residual solvents and waste management.

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Distribution and Packaging Aspects

API suppliers generally package Iopamidol-250 in plastic drums or containers, ranging in volume from 10 kg to 50 kg. The choice of plastic materials (e.g., high-density polyethylene or polypropylene) is driven by chemical compatibility, product stability, and ease of handling.

Producers typically ensure airtight, light-resistant, and tamper-evident packaging to maintain API integrity during transportation and storage. This facilitates subsequent filling into plastic containers for clinical use, aligning with sterile processing and hospital pharmacy requirements.

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Supply Chain Challenges and Considerations

• Regulatory Variability: Navigating differing regional certifications can impact sourcing decisions.
• Quality Consistency: Ensuring batch-to-batch uniformity is critical given the injectable nature of Iopamidol.
• Supply Security: Overreliance on regional suppliers poses risks; diversification strategies are recommended.
• Pricing Fluctuations: Market dynamics influence API costs, affecting overall healthcare procurement budgets.

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Emerging Trends in API Sourcing

• Local Manufacturing Expansion: Countries are incentivizing domestic API production to mitigate supply chain disruptions.
• Quality Harmonization: International regulatory bodies are working towards aligning standards, facilitating easier cross-border procurement.
• Sustainable Practices: Suppliers increasingly adopt environmentally sustainable manufacturing practices, aligning with global health and environmental standards.

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Key Takeaways

• Reliable procurement of Iopamidol-250 bulk API hinges on partnering with GMP-certified manufacturers dedicated to strict quality standards.
• Leading regional suppliers, such as Giga-Industry (India), Zhejiang Huayi (China), and Bracco Imaging (Italy), dominate the global supply landscape.
• Packaging in plastic drums is standard, facilitating downstream filling into plastic containers for clinical and hospital use.
• Regulatory compliance, documentation, and product stability are paramount considerations during sourcing.
• Diversifying supplier base and monitoring market trends can enhance supply chain resilience amid geopolitical and economic fluctuations.

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FAQs

1. What are the primary quality standards to verify when sourcing Iopamidol-250 API?
API suppliers should provide Certificates of Analysis aligning with pharmacopeial specifications (USP, EP, JP), including assay purity (>99%), residual solvent limits, endotoxin levels, and stability data, all produced under GMP conditions.

2. Which regions dominate global supply for Iopamidol-250 API?
Asia-Pacific (notably India and China), Europe (Italy and Germany), and North America (United States) are the principal regions with established API manufacturing capacities.

3. How does packaging influence API stability and subsequent clinical use?
Packaging in high-density polyethylene or polypropylene plastic drums ensures chemical compatibility, protection from light and moisture, and ease of transport, thereby maintaining API integrity until downstream formulation.

4. Are there regulatory challenges in importing APIs like Iopamidol-250?
Yes, import compliance requires adherence to regional regulatory standards, including registration, certification, and documentation, which can vary significantly depending on the destination market.

5. What strategies can healthcare providers adopt to secure a stable supply of Iopamidol-250 API?
Providers should diversify sourcing, establish long-term contracts with GMP-certified suppliers, and stay updated on global regulatory changes and market developments.

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Sources:

1. Pharmaceutical Technology: API manufacturing trends.
2. WHO List of GMP-approved production sites.
3. European Medicines Agency (EMA): Regulatory requirements for APIs.
4. US FDA: Guidance for Industry – API Quality Standards.
5. Industry reports and press releases from companies such as Giga-Industry, Zhejiang Huayi, Bracco, and GE Healthcare.