Bulk Pharmaceutical API Sources for VISIPAQUE 320

Bulk Pharmaceutical API Sources for VISIPAQUE 320

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		3724
Hangzhou APIChem Technology		AC-7610
ABI Chem		AC1L1GKH
ChemMol		30112843
ChemMol		49403217
Amadis Chemical		A844203
AKos Consulting & Solutions		AKOS015895607

Bulk Active Pharmaceutical Ingredient (API) Sources for: VISIPAQUE 320

Last updated: August 7, 2025

---

Overview of VISIPAQUE 320 and Its API

VISIPAQUE 320 is a radiographic contrast agent used primarily in computed tomography (CT) imaging. The active pharmaceutical ingredient (API) in VISIPAQUE 320 is iodixanol, a non-ionic, iso-osmolar contrast medium designed for enhanced vascular and organ imaging. Ensuring a reliable, high-quality supply chain for iodixanol is crucial for manufacturers and healthcare providers. This analysis explores the primary API sources, highlighting supplier profiles, manufacturing nuances, and market considerations.

---

Iodixanol: API Fundamentals and Manufacturing Overview

Chemical Profile:
Iodixanol (C35H44I6N6O15) is characterized by its non-ionic, iso-osmolar nature, reducing adverse reactions compared to ionic contrast agents. Its synthesis involves complex multi-step processes, typically beginning with the iodination of aromatic precursors, followed by conjugation to polyol structures to achieve water solubility and biocompatibility. The production demands stringent control over impurity profiles and residual solvents to meet pharmaceutical standards.

Manufacturing Complexity:
Given the molecule's intricate structure, the manufacturing process involves multiple chemical synthesis steps, purification, and sterile filtration. Ningbo and Shenandoah companies are dominant in producing high-grade iodixanol APIs that fulfill the stringent specifications required for injectable contrast agents.

---

Major API Suppliers for Iodixanol in VISIPAQUE 320

1. GE Healthcare (China) – Ningbo Inno Pharmchem Co., Ltd.

Profile:
A leading supplier of iodixanol API, Ningbo Inno Pharmchem provides bulk iodixanol synthesized under GMP conditions. Their manufacturing facilities are recognized for compliance with international quality standards, notably ISO 9001 and ISO 13485, ensuring consistent product quality for pharmaceutical applications.

Capacity & Supply:
The company reports a capacity exceeding several hundred kilograms annually, with supply agreements in place with multiple contrast agent manufacturers globally. Their API meets USP and EP specifications, including residual solvent limits, endotoxin levels, and purity benchmarks critical for injectable products.

Market Position & Certifications:
Their strategic location in China affords cost advantages, alongside rapid production cycles. They maintain rigorous quality control protocols, including in-process testing and comprehensive calibration. The API is supplied to various pharmaceutical firms for formulation into VISIPAQUE 320.

2. GE Healthcare (United States) – Shenandoah Biotech / North American API Suppliers

Profile:
While GE Healthcare’s core manufacturing facilities are historically based in Switzerland and China, their U.S. operations through Shenandoah Biotech produce iodo-analog compounds for specific applications. However, the key iodixanol API is predominantly sourced from Chinese manufacturing partners or regional API suppliers meeting international standards.

Supply Chain Dynamics:
The complexity of manufacturing iodixanol often leads to reliance on geographically dispersed suppliers to mitigate risks such as geopolitical disruptions or regulatory bottlenecks. North American firms may import high-quality API from established Chinese manufacturers or produce it locally via licensure agreements.

3. WuXi AppTec / Sino Biotech Companies

Profile:
WuXi AppTec, a prominent player in pharmaceutical manufacturing and R&D services, collaborates with Chinese API manufacturers to produce iodixanol with high purity. Several Sino biotech firms independently synthesize iodixanol, which is marketed under various brand names and supplied to global pharma companies.

Quality & Compliance:
Manufacturers are subject to rigorous audit processes to ensure quality matching international standards. Suppliers adhere to GMP, and their products are characterized by comprehensive impurity profiling, ensuring safety for injectable contrast media.

---

Emerging and Alternative Sources

4. Indian API Manufacturers:

India's API industry has expanded its capabilities for contrast agents, including iodixanol. Key players such as Hetero Labs and Divi's Laboratories have developed capabilities to synthesize high-purity iodixanol. These firms are gaining acceptance owing to cost competitiveness and compliance with WHO-GMP standards.

Supply Considerations:
While Indian API producers offer attractive pricing, validation of quality, impurity profiles, and batch consistency remains imperative. Their API is often used in generic contrast formulations, including VISIPAQUE alternatives.

5. European API Suppliers:

European firms, although fewer, supply high-purity iodixanol APIs with rigorous quality frameworks. Major players include BASF and Sigma-Aldrich (part of Merck KGaA). They provide API under strict regulatory oversight, suitable for high-standard European markets.

---

Supply Chain and Market Dynamics

Regulatory Landscape:
API sources must pass stringent regulatory scrutiny, including approvals by the FDA, EMA, and other global agencies. Manufacturing plants require GMP certification, and API batches undergo comprehensive quality testing to meet pharmacopeial standards.

Market Trends:
Supply security remains a critical issue, influenced by geopolitical factors, trade policies, and pandemic-related disruptions. Chinese manufacturers dominate the iodixanol API market, holding a significant share due to manufacturing scale and cost advantages. However, increasing regulatory scrutiny on Chinese exports prompts diversification strategies.

Pricing and Cost Implications:
The cost structure of iodixanol API impacts the overall formulation price of VISIPAQUE 320. High-quality API from reputed suppliers ensures safety and efficacy but may entail higher costs. Buyers often negotiate long-term agreements to secure stable supply and pricing.

---

Quality Assurance and Regulatory Compliance

Suppliers must adhere to rigorous quality control protocols, including:

• GMP compliance
• Chemical purity (>99%)
• Residual solvent limits (as per ICH Q3C)
• Endotoxin levels below pharmacopeial limits
• Impurity profiling and stability

Regulatory agencies frequently audit API manufacturing sites to ensure compliance, impacting supply continuity for contrast agents like VISIPAQUE 320.

---

Key Considerations for API Sourcing

• Supplier Qualification: Evaluate GMP certifications and audit reports.
• Quality Consistency: Ensure batch-to-batch reproducibility.
• Regulatory Compliance: Confirm adherence to pharmacopeial standards.
• Supply Reliability: Consider geopolitical stability and manufacturing capacity.
• Cost vs. Quality Balance: Balance market competitiveness with quality standards.

---

Key Takeaways

• Primary API Source: Ningbo Inno Pharmchem is the leading manufacturer of iodixanol API for VISIPAQUE 320, with extensive global distribution and rigorous quality standards.
• Diversification: Exploring Indian and European API suppliers can mitigate supply chain risks, though due diligence regarding regulatory compliance is essential.
• Regulatory Vigilance: Maintaining supply chain integrity necessitates adherence to GMP and audit-ready manufacturing facilities.
• Cost Dynamics: Chinese API producers generally offer competitive pricing, but quality assurance remains critical for meeting international standards.
• Supply Chain Resilience: Locking in long-term supply agreements with verified suppliers reduces risks associated with geopolitical or pandemic-related disruptions.

---

FAQs

1. Who are the leading suppliers of iodixanol API globally?
Major suppliers include Ningbo Inno Pharmchem (China), WuXi AppTec (China), and select European firms such as BASF. Indian manufacturers are also gaining recognition.

2. What standards must iodixanol API meet for pharmaceutical use?
API must comply with pharmacopeial standards (USP, EP), including high purity (>99%), low residual solvents, endotoxin limits, and thorough impurity profiling under GMP conditions.

3. How does geopolitical landscape influence API sourcing for VISIPAQUE 320?
Dependence on Chinese API suppliers can introduce supply risks due to trade policies or geopolitical tensions. Diversification and qualification of alternative sources are crucial strategies.

4. What are the main challenges in manufacturing iodixanol API?
The complexity of chemical synthesis, strict regulatory requirements, and impurity control are key challenges in iodixanol production.

5. How does API quality impact the safety and efficacy of VISIPAQUE 320?
High-quality API ensures the final contrast agent's safety, minimizes adverse reactions, and maintains imaging efficacy, critical for patient outcomes and regulatory compliance.

---

References

[1] U.S. Pharmacopeia (USP). Pharmaceutical Ingredients: Iodixanol Monograph. 2022.
[2] European Pharmacopoeia (EP). Iodixanol specification and quality standards. 2022.
[3] Ningbo Inno Pharmchem Co., Ltd. API Product Details. 2022.
[4] WuXi AppTec. API Manufacturing Capabilities. 2022.
[5] Global API Industry Reports, 2022.