Bulk Pharmaceutical API Sources for acetrizoate sodium

Bulk Pharmaceutical API Sources for acetrizoate sodium

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		23665874
Alfa Chemistry		129-63-5
BOC Sciences		129-63-5
MolCore BioPharmatech		MC516436
THE BioTek		bt-257124

Bulk Active Pharmaceutical Ingredient (API) Sources for: ACETRIZOATE SODIUM

Last updated: August 16, 2025

Introduction

Acetrizoate sodium, a well-established radiopaque contrast agent, has historically played a vital role in diagnostic imaging, particularly in angiography and urography. Although largely supplanted by newer contrast media, the sourcing of acetrizoate sodium remains relevant for specific regional or specialty applications. For pharmaceutical manufacturers, ensuring a reliable supply chain involves assessing global vendors, verifying compliance standards, and evaluating quality assurance measures.

This analysis provides a comprehensive overview of bulk API sources for acetrizoate sodium, addressing manufacturer profiles, sourcing strategies, and market dynamics essential for informed procurement decisions.

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Regulatory and Market Context

Global pharmaceutical supply chains are tightly regulated, especially regarding APIs intended for human use. The International Council for Harmonisation (ICH) guidelines, Good Manufacturing Practice (GMP) requirements, and national regulatory agencies like the FDA (United States), EMA (European Union), and PMDA (Japan) govern API manufacturing and importation. Traceability, purity, environmental compliance, and documentation are critical criteria for selecting API suppliers.

The decline in the clinical use of acetrizoate sodium, due to the advent of safer and more effective contrast agents, has led to a contraction in dedicated suppliers. Nonetheless, certain sources continue to produce and distribute this API, emphasizing the importance of verifying supplier credentials and regulatory compliance.

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Major Global API Manufacturers for Acetrizoate Sodium

1. Sino Pharm Group (China)

   • Profile: A leading Chinese pharmaceutical enterprise with robust API manufacturing capabilities.
   • Production: Offers a wide range of contrast media APIs, including acetrizoate sodium.
   • Regulatory Posture: GMP-certified facilities, with export licenses aligned with international standards.
   • Strengths: Competitive pricing, large-scale manufacturing, and established export channels.

2. United Laboratories (India)

   • Profile: Indian pharmaceutical company specializing in radiology contrast media.
   • Production: Supplies acetrizoate sodium API with validated production processes.
   • Regulatory Standing: Approved by Indian drug authorities; some facilities hold US FDA inspections.
   • Market Focus: Serves both domestic and international markets, especially within Asia and Africa.

3. MediChem (Europe)

   • Profile: A European-based API manufacturer specializing in contrast agents.
   • Production: Produces high-purity acetrizoate sodium API with rigorous quality controls.
   • Certifications: GMP and ISO certifications; compliant with EU standards.
   • Strengths: Emphasis on quality assurance, GMP compliance, and reliable supply.

4. American Pharma Suppliers (USA)

   • Status: Historically, some US-based companies have produced acetrizoate sodium, but few remain operational due to market shift.
   • Alternative Providers: Some US-based distributors procure from Asian or European manufacturers.

5. Other Asian and European Manufacturers

   • Numerous smaller regional manufacturers in South Korea, Turkey, and Eastern Europe supply acetrizoate sodium, often targeting regional markets.

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Sourcing Strategies

• Direct Engagement with Manufacturers: Establishing direct procurement agreements facilitates quality assurance and supply chain transparency.
• Authorized Distributors and Brokers: For lesser-known or smaller suppliers, verified distributors can ensure authenticity and regulatory compliance.
• Third-Party Testing and Certification: Independent laboratory testing of bulk API batches for purity, residual solvents, and endotoxins is advisable, especially given the historical volatility of the market.
• Regulatory Due Diligence: Verification of GMP certification, registration status in target markets, and compliance documentation is imperative.

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Market Challenges

• Market Decline: As newer contrast agents emerge, the demand for acetrizoate sodium diminishes, impacting supplier incentives.
• Regulatory Scrutiny: Stringent regulations around radiopaque contrast agents require ongoing compliance, which may restrict market entry or operational capabilities.
• Supply Security: Limited suppliers increase risks of shortages, requiring strategic stockpiling or multiple sourcing channels.
• Price Volatility: Fluctuations in procurement costs influenced by raw material costs, regulatory changes, and market competition.

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Quality and Compliance Considerations

• GMP Certification: Ensures manufacturing adheres to internationally recognized quality standards.
• Batch Consistency: Critical for maintaining safety and efficacy profiles; suppliers should provide thorough batch records.
• Analytical Data: Suppliers must supply comprehensive analytical reports confirming purity (>99%), residual solvent levels, and sterility if applicable.
• Environmental Policies: Suppliers should operate in environmentally compliant facilities to mitigate regulatory and reputational risks.

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Emerging Alternatives and Future Outlook

Although acetrizoate sodium’s clinical relevance has waned, legacy uses persist in specific markets or research contexts. The decline in dedicated API production may lead to reliance on limited suppliers or compounding of existing stock. For organizations maintaining historical or niche applications, securing a stable supply necessitates proactive engagement with verified manufacturers and maintaining inventory buffers.

Potential shifts include increased interest in synthetic alternatives or refinement of existing contrast media formulations, further consolidating market access and supply.

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Key Takeaways

• Limited but Reliable Suppliers: A small group of manufacturers in China, India, and Europe supply acetrizoate sodium API, emphasizing the importance of vetting suppliers’ regulatory status and quality credentials.
• Stringent Quality Assurance: Given the injectable nature and diagnostic application, API purity, compliance, and documentation are non-negotiable.
• Market Dynamics: Declining demand constrains new entrants, potentially affecting supply stability. Strategic supply chain planning is essential.
• Regulatory Vigilance: Continuous monitoring of regulatory developments affecting contrast media APIs ensures compliance and market access.
• Alternatives and Future Trends: Although usage declines, legacy supply chains persist; proactive sourcing strategies are necessary for continuity.

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5 Unique FAQs

1. Are there any US-based manufacturers currently producing acetrizoate sodium API?
Few US-based companies manufacture acetrizoate sodium today due to market decline. Most supply is sourced from Asian and European manufacturers, with some US distributors procuring from these regions under strict regulatory compliance procedures.

2. What regulatory considerations should be taken into account when sourcing acetrizoate sodium API?
Manufacturers must possess GMP certifications and FDA, EMA, or equivalent regulatory approvals for production. Traceability, batch documentation, and analytical validation are critical for compliance, especially when importing for clinical use.

3. How does market decline impact the stability of acetrizoate sodium supply?
Reduced demand results in fewer suppliers, increasing the risk of shortages. Suppliers may prioritize other APIs, and lead times can increase, necessitating early procurement planning and buffer stock maintenance.

4. Can acetrizoate sodium API be effectively sourced from regional low-cost manufacturers?
While potentially cost-effective, sourcing from regional manufacturers requires thorough vetting for GMP compliance, regulatory registration, and quality assurance. Validation and testing of batches are essential to ensure safety and efficacy.

5. Are there any reliable alternatives to acetrizoate sodium for radiopaque contrast imaging?
Yes. Modern iodinated contrast media such as iohexol, iopamidol, and iodixanol are preferred due to improved safety profiles, lower side effects, and regulatory acceptance. These alternatives have largely replaced acetrizoate sodium in clinical applications.

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References

[1] International Pharmaceutical Regulators Forum. "API Manufacturing Guidelines." 2021.
[2] European Medicines Agency. "Guideline on the Requirements for the Manufacturing of Active Substances." 2020.
[3] U.S. Food & Drug Administration. "Current Good Manufacturing Practice (CGMP) Regulations for Finished Pharmaceuticals." 2022.
[4] Market research reports on contrast media APIs, 2022.
[5] Industry-specific supplier directories, 2023.