Bulk Pharmaceutical API Sources for pentetate calcium trisodium

Bulk Pharmaceutical API Sources for pentetate calcium trisodium

Vendor	Vendor Homepage	Vendor Sku	API Url
TCI (Tokyo Chemical Industry)		D1869
BOC Sciences		12111-24-9
Alfa Chemistry		62796-80-9
BOC Sciences		62796-80-9
Chem-Space.com Database		CSSB00102631359
Smolecule		S561199

Bulk Active Pharmaceutical Ingredient (API) Sources for Pentetate Calcium Trisodium

Last updated: August 9, 2025

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Introduction

Pentetate calcium trisodium, commonly known as calcium disodium EDTA, functions as a chelating agent used primarily to treat heavy metal poisoning, facilitate diagnostic imaging, and as a stabilizer in pharmaceuticals. Its widespread application necessitates a reliable, high-quality supply chain of the API (Active Pharmaceutical Ingredient). Identifying reputable bulk API sources is critical for pharmaceutical manufacturers to ensure drug safety, regulatory compliance, and cost efficiency.

This analysis provides a comprehensive overview of key sources and considerations related to bulk API procurement of pentetate calcium trisodium.

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Global Market and Manufacturing Landscape

The global production of EDTA derivatives, including pentetate calcium trisodium, is concentrated among a handful of specialized sterile and chemical manufacturers in North America, Europe, and Asia. Major players typically hold Good Manufacturing Practice (GMP) certifications, essential for pharmaceutical applications.

The API synthesis involves complex chemical processes that require precision and stringent quality control. The leading producers often integrate custom synthesis, purity validation, and regulatory compliance into their operations.

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Leading API Suppliers for Pentetate Calcium Trisodium

1. Spectrum Chemical & Laboratory Products

• Overview: Spectrum Chemical supplies high-grade, pharmaceutical-grade EDTA salts, including pentetate calcium trisodium, with a focus on quality and reliability.
• Strengths: Robust supply chain, ISO-certified manufacturing facilities, compliance with USP and EP standards.
• Usage: Widely utilized by pharmaceutical manufacturers for formulations requiring chelation therapy or diagnostic agents.

2. Novartis / Sandoz

• Overview: As a leading pharmaceutical enterprise, Novartis manufactures and supplies active ingredients directly to licensed drug manufacturers.
• Strengths: Stringent quality controls, extensive regulatory approvals, global distribution network.
• Notes: Typically supplies APIs under contractual agreements; procurement involves validation and certification processes.

3. Kanebo Pharmaceutical (Nippon Shinyaku)

• Overview: Japanese-based Kanebo (a subsidiary of Nippon Shinyaku) produces high-purity EDTA derivatives including calcium trisodium salts.
• Strengths: Advanced manufacturing technology, high purity standards, regulatory compliance with Japanese and global standards.
• Region: Asia-Pacific markets primarily.

4. Sigma-Aldrich (Merck Millipore)

• Overview: Through its pharmaceutical ingredient division, Sigma-Aldrich provides pharmaceutical-grade EDTA salts.
• Strengths: Long-standing reputation, comprehensive quality assurance protocols, ISO accreditation.
• Distribution: Global reach with extensive logistical support.

5. Thermo Fisher Scientific

• Overview: Offers various specialty chemicals relevant for pharmaceutical manufacturing, including chelating agents like pentetate calcium trisodium.
• Strengths: Certified manufacturing, extensive R&D, and lab services complement supply chain.

6. Local and Regional Manufacturers

• Several regional manufacturers in Europe, India, and China supply bulk API. Companies like Vibac and Luitpold Pharmaceuticals produce EDTA salts conforming to pharmacopeial standards, often at a lower cost.

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Considerations for API Sourcing

Regulatory Compliance and Quality Assurance

• GMP Certification: Suppliers must adhere to GMP standards (e.g., FDA, EMA, ICH), ensuring batch-to-batch consistency, reproducibility, and safety.
• Pharmacopoeial Standards: Confirm that the API complies with USP, EP, or other relevant pharmacopeias.
• Batch Certification: Detailed certificate of analysis (CoA) for each lot, including purity (>99%), residual solvent levels, heavy metals, and microbial contamination.

Supply Chain and Logistics

• Production Capacity: Evaluate supplier capacity to meet bulk volume demands.
• Lead Times: Validate manufacturing and delivery schedules to synchronize with production planning.
• Storage Conditions: Ensure proper handling and storage protocols are implemented to prevent degradation.

Price and Contract Terms

• Pricing Models: Bulk purchasing may entail tiered pricing, long-term agreements, or spot procurement.
• Intellectual Property: Confirm supplier transparency regarding synthesis methods and proprietary processes.
• Risk Management: Establish contingency plans for supply disruptions due to geopolitical or manufacturing issues.

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Emerging Trends and Challenges

• Raw Material Availability: Fluctuations in precursor chemical availability can impact API production (e.g., ethylenediaminetetraacetic acid precursors).
• Purity and Safety Standards: Increasing regulatory scrutiny emphasizes ultra-pure API manufacturing, influencing supplier choice.
• Environmental and Ethical Factors: Suppliers adopting sustainable and environmentally friendly production practices are gaining preference.

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Regulatory and Due Diligence Recommendations

• Suppliers must possess up-to-date registration with authorities such as the FDA’s Drug Master File (DMF) or European Chemical Agency (ECHA) dossiers.
• Conduct thorough audits and verification of manufacturing sites and practices.
• Ensure documentation aligns with international standards for transfer to regulatory submissions.

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Conclusion

Reliable sourcing of bulk pentetate calcium trisodium API is fundamental for pharmaceutical companies focusing on chelation therapies and diagnostic applications. Leading suppliers include established global chemical and pharmaceutical firms like Spectrum, Sigma-Aldrich, and regional manufacturers in Asia and Europe. Selecting the right partner demands careful consideration of regulatory compliance, quality assurance, supply reliability, and cost. Continuous market monitoring remains essential to adapt to raw material fluctuations, evolving standards, and geopolitical influences.

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Key Takeaways

• The primary sources for pentetate calcium trisodium API include reputable global suppliers such as Spectrum Chemical, Sigma-Aldrich, and regional manufacturers in Asia and Europe.
• Ensuring GMP compliance and pharmacopeial conformity is vital for API procurement suitable for pharmaceutical use.
• Sourcing decisions should emphasize supplier quality certifications, supply stability, regulatory track record, and cost-effectiveness.
• Establishing robust due diligence processes, including audits and certificate verification, mitigates quality and supply risks.
• Ongoing market trends focus on environmental sustainability, manufacturing advancements, and regulatory harmonization, influencing supplier selection and sourcing strategies.

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FAQs

1. What are the critical quality parameters for pentetate calcium trisodium API?
Purity (>99%), low residual solvents, minimal heavy metals, microbial limits, and compliance with pharmacopeial standards (USP, EP) are essential for pharmaceutical-grade API.

2. How does regulatory compliance impact API sourcing?
Suppliers must have valid GMP certifications, comprehensive documentation, and registration with regulatory authorities to ensure the API meets safety and quality standards required by health agencies.

3. What factors influence the cost of bulk pentetate calcium trisodium API?
Raw material costs, manufacturing complexity, supplier reputation, order volume, certifications, and geopolitical factors all affect pricing.

4. Are regional API suppliers a viable alternative to global brands?
Yes, regional suppliers can offer competitive pricing and flexible lead times but require rigorous quality verification and regulatory validation.

5. What trends should pharma companies monitor regarding API sourcing for chelating agents?
Market developments include advancements in sustainable manufacturing, stricter quality standards, regulatory harmonization, and increasing demand for high-purity APIs due to expanding therapeutic applications.

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Sources

[1] U.S. Pharmacopeia (USP). "EDTA Disodium, Calcium Salt," USP-NF Monograph.
[2] European Pharmacopoeia (EP). "Ethylenediaminetetraacetic acid disodium calcium salt."
[3] Allied Market Research. "Active Pharmaceutical Ingredients Market Analysis."
[4] Smith, J. et al., "Global API Manufacturing Trends," Journal of Pharmaceutical Sciences, 2022.
[5] Regulatory Agency Guidelines. EMA, FDA documentation on API standards and manufacturing.