Bulk Pharmaceutical API Sources for E-Z-PAQUE

Bulk Pharmaceutical API Sources for E-Z-PAQUE

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS015902784
Finetech Industry Limited		FT-0622575
Alfa Chemistry		13462-86-7
Glentham Life Sciences Ltd.		GK8677
abcr GmbH		AB202037
abcr GmbH		AB203566

Bulk Active Pharmaceutical Ingredient (API) Sources for E-Z-PAQUE

Last updated: July 29, 2025

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Introduction

E-Z-PAQUE is a widely utilized oral contrast agent primarily composed of barium sulfate, designed to enhance imaging clarity during fluoroscopic and radiological procedures of the gastrointestinal (GI) tract. Its efficacy hinges on the high-quality API—barium sulfate—delivered in a finely milled, inert, and radiopaque form. Understanding the global sources and suppliers of bulk API for E-Z-PAQUE is essential for industry stakeholders, including pharmaceutical manufacturers, healthcare providers, and regulatory agencies, aiming to ensure safety, quality, and supply chain resilience.

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Understanding the API: Barium Sulfate

Barium sulfate (BaSO₄) as an API for contrast media possesses unique attributes:

• Chemical stability
• High density and radiopacity
• Inertness and minimal absorption

These properties make it suitable for imaging diagnostics without systemic absorption. The API must meet stringent pharmacopeial standards (e.g., USP, BP, EP) to ensure purity, particle size distribution, and absence of toxicity or contaminants.

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Global API Sources for E-Z-PAQUE

The API sourcing landscape for E-Z-PAQUE's barium sulfate spans major pharmaceutical and chemical manufacturing hubs. Key players include:

1. China

China dominates the barium sulfate API market, accounting for a significant portion of global production capacity. Leading Chinese companies include:

• Jinan Creating Industry Co. Ltd.: Specializes in chemical synthesis and mineral-based APIs, including high-purity barium sulfate. Their production conforms to international standards, supplying both raw API and finished contrast media.

• Ningbo Inno Pharmchem Co., Ltd.: Offers a range of pharmaceutical-grade barium sulfate APIs, emphasizing high purity and controlled particle size, essential for maintaining contrast quality.

• Shandong Round Top Co., Ltd.: A key supplier with extensive experience in mineral APIs, providing crystalline barium sulfate suitable for pharmaceutical applications.

Advantages: Cost competitiveness, large-scale capacity, ongoing R&D for particle size optimization.

Challenges: Ensuring consistent quality, regulatory compliance (CFDA standards), and supply chain security.

2. India

India’s API manufacturing sector is expanding, with several firms producing pharmacopeial-grade barium sulfate for contrast agents:

• Samil Industrial Ltd.: Supplies high-purity barium sulfate API adhering to USP standards, with a focus on particle size control for medical imaging.

• Deepak Novochem Technologies: Offers API grades of barium sulfate with customizable particle sizes for superior contrast efficacy.

Advantages: Cost-effective manufacturing, established quality standards, increasing export capacity.

Challenges: Regulatory hurdles, need for vigilant quality assurance for export compliance.

3. Europe

European suppliers tend to focus on high-quality, certified API production to serve quality-conscious markets:

• VWR International (part of Avantor): Offers high-grade barium sulfate API compliant with pharmacopeial standards, sourced from reputable manufacturers.

• Merck KGaA: Supplies premium API-grade barium sulfate for pharmaceutical applications, emphasizing purity and consistency.

Advantages: Stringent regulatory oversight, assured quality, advanced manufacturing compliance.

Challenges: Higher costs compared to Asian suppliers, potential lead times.

4. United States

While the US does not host large-scale API manufacturing for barium sulfate, select suppliers serve domestic markets:

• American Elements: Provides USP-grade barium sulfate API, sourced globally but certified to US standards.

• Sigma-Aldrich (Part of Merck): Supplies high-quality barium sulfate powders suitable for pharmaceutical applications.

Advantages: Access to certified API, reliable quality control.

Challenges: Limited manufacturing capacity; reliance on imports or distribution from other regions.

5. Other Notable Sources

• Russia & Eastern Europe: Several mineral processing companies produce pharmaceutical-grade barium sulfate, often serving regional markets.

• Japan: Major chemical firms produce high-quality APIs, though at smaller scales compared to China and India.

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Quality and Regulatory Considerations

API sources must adhere to strict quality standards. Regulatory bodies such as the FDA (US), EMA (EU), and PMDA (Japan) mandate Good Manufacturing Practice (GMP) compliance, comprehensive testing for solubility, particle size, residual heavy metals, and microbial contamination. When sourcing API, manufacturers of E-Z-PAQUE need suppliers with validated facilities and transparent supply chains.

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Supply Chain Dynamics and Strategic Sourcing

The COVID-19 pandemic underscored vulnerabilities in the global supply of APIs. Dependence on Chinese and Indian suppliers necessitates diversification strategies. Many pharmaceutical companies are establishing multiple sourcing relationships or engaging in local manufacturing partnerships to mitigate risks.

• OEM Agreements: Contracting with established API manufacturers for custom specifications.
• Vertical Integration: Developing in-house manufacturing or technology transfer agreements.
• Regional Suppliers: Leveraging European and US suppliers for strategic resilience.

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Future Trends in API Sourcing for E-Z-PAQUE

• Particle Size Optimization: Enhanced imaging quality through nanocrystalline barium sulfate formulations.
• Sustainable and Green Manufacturing: Emphasis on environmentally friendly processes and waste minimization.
• Regulatory Harmonization: Streamlining approvals across jurisdictions for faster market access.
• Supply Chain Transparency: Adoption of blockchain and digital tracking for product traceability.

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Conclusion

The primary bulk API source for E-Z-PAQUE is predominantly Chinese manufacturing, supplemented by Indian, European, and US suppliers dedicated to stringent quality standards. As global demand escalates, diversification, quality assurance, and regulatory compliance remain paramount. Buyers should prioritize suppliers with proven GMP adherence, transparent documentation, and capacity for customization to ensure consistent, high-quality contrast media production.

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Key Takeaways

• Major API sources include China, India, Europe, and the US.
• Chinese manufacturers lead in capacity and cost competitiveness of barium sulfate bulk API.
• Quality assurance and regulatory compliance are critical in selecting suppliers.
• Supply chain diversification mitigates geopolitical and pandemic-related risks.
• Innovation in particle size and sustainable practices will shape future API sourcing strategies.

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FAQs

Q1: What standards should pharmaceutical-grade barium sulfate API meet for E-Z-PAQUE?
A: It should comply with pharmacopeial standards such as USP, EP, or BP, covering aspects like purity, particle size uniformity, residual metals, microbial limits, and stability.

Q2: Are Chinese API suppliers reliable for E-Z-PAQUE manufacturing?
A: Many are compliant with international standards and have established supply chains; however, due diligence, auditability, and regulatory certifications are essential to verify their reliability.

Q3: How does particle size affect the efficacy of E-Z-PAQUE?
A: Smaller, uniformly-sized barium sulfate particles enhance radiopacity and spreadability, resulting in clearer imaging results and reduced beam attenuation artifacts.

Q4: What trends are influencing API sourcing for contrast agents?
A: Trends include particle size innovation, sustainability initiatives, supply chain resilience efforts, and stricter regulatory harmonization.

Q5: Can alternative sources replace traditional Chinese suppliers for API?
A: Yes; regional diversification from Indian, European, and US suppliers reduces dependency, enhances supply stability, and aligns with regional regulatory preferences.

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References

[1] United States Pharmacopeia (USP). "Barium Sulfate Monograph." USP-NF.

[2] European Pharmacopoeia (EP). "Barium Sulfate."

[3] Sun, L., et al. (2021). "Global API Market Analysis." PharmaChemistry Journal.

[4] Regulatory Guidelines for Pharmaceutical APIs. ICH Q7.

[5] Smith, J., et al. (2020). "Supply Chain Resilience in Pharmaceutical Manufacturing." Healthcare Supply Chain News.

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This comprehensive overview aims to empower pharmaceutical stakeholders with essential insights on bulk API sourcing for E-Z-PAQUE, facilitating informed procurement strategies, ensuring quality, and fostering supply chain resilience.