Bulk Pharmaceutical API Sources for EDETATE CALCIUM DISODIUM

Bulk Pharmaceutical API Sources for EDETATE CALCIUM DISODIUM

Vendor	Vendor Homepage	Vendor Sku	API Url
TCI (Tokyo Chemical Industry)		E0088
Amadis Chemical		A833722
AKos Consulting & Solutions		AKOS015902995
AKos Consulting & Solutions		AKOS015914896
Molport		MolPort-006-110-160

Bulk Active Pharmaceutical Ingredient (API) Sources for Edetate Calcium Disodium

Last updated: July 28, 2025

Introduction

Edetate Calcium Disodium, also known as calcium disodium EDTA, is a chelating agent with widespread medical and industrial applications. It is primarily used in clinical settings for the treatment of heavy metal poisoning, such as lead poisoning, and as an additive in food preservation, cosmetics, and industrial processes. Ensuring consistent, high-quality sourcing of Edetate Calcium Disodium API is essential for pharmaceutical manufacturers, regulators, and end-users. This analysis focuses on global suppliers, manufacturing origins, and market trends for bulk Edetate Calcium Disodium, emphasizing quality assurance, regulatory compliance, and supply chain considerations.

Overview of Edetate Calcium Disodium API

Edetate Calcium Disodium is a salt form of EDTA (ethylenediaminetetraacetic acid), with calcium and disodium ions complexed to enhance stability and reduce toxicity. Its solubility and chelating properties make it ideal for medical chelation therapy and as a stabilizer in various formulations. The API's purity, particle size, and compliance with pharmacopeial specifications are critical for pharmaceutical use, often demanding rigorous quality control and traceability from suppliers.

Global Supply Landscape

1. Leading Manufacturers and Suppliers

The main sources of Edetate Calcium Disodium API are concentrated in regions with established chemical manufacturing infrastructure, primarily China, India, Europe, and North America.

a. China

China dominates the global API manufacturing sector owing to its extensive chemical production capabilities. Several Chinese companies are recognized for producing high-quality Edetate Calcium Disodium API that complies with international standards such as the USP, BP, and EP.

• China National Pharmaceutical Group (Sinopharm): Offers a range of pharmaceutical-grade chelating agents, including Edetate Calcium Disodium, with a focus on quality and regulatory compliance.
• Hubei Green House Bacillus Co., Ltd.: Known for producing chelating agents and specialty chemicals for pharmaceutical applications.
• Shandong Fuxin Pharmaceutical Co., Ltd.: Supplies Edetate Calcium Disodium powder suitable for bulk pharmaceutical use.

Chinese APIs generally meet stringent quality standards when sourced from certified, GMP-compliant facilities; however, due diligence remains necessary to verify batch-specific specifications.

b. India

India’s API manufacturing sector is robust, with companies offering high-quality Edetate Calcium Disodium suitable for pharmaceutical applications.

• Gufic Biosciences Ltd.: Provides certified APIs, including chelating agents, targeting domestic and export markets.
• Fresenius Kabi India: Offers APIs with stringent quality assurance aligned with international standards.

Indian suppliers often adhere to WHO-GMP standards, making their APIs suitable for global markets, especially in regions with regulatory recognition of Indian manufacturing practices.

c. Europe

European manufacturers emphasize regulatory compliance, often with advanced quality control capabilities.

• BASF SE (Germany): Produces pharmaceutical excipients and chemicals, including chelating agents, with comprehensive compliance with European pharmacopoeial standards.
• Evonik Industries (Germany): Provides specialty chemicals and APIs for pharmaceutical formulations, including EDTA compounds.

European APIs are often preferred for their stringent manufacturing practices and proven quality standards.

d. North America

North American suppliers focus on high-quality, GMP-compliant APIs.

• Sigma-Aldrich/Merck (USA/Germany): Offers pharmaceutical-grade Edetate Calcium Disodium for research and industrial use.
• Thermo Fisher Scientific: Supplies bulk chemical-grade EDTA derivatives to pharmaceutical manufacturers.

2. Quality Standards and Regulatory Compliance

Top suppliers routinely meet the following standards:

• United States Pharmacopeia (USP):
• British Pharmacopoeia (BP):
• European Pharmacopoeia (EP):
• WHO-GMP standards for manufacturing practices

Suppliers with certifications such as ISO 9001, ISO 13485, and specific GMP certifications demonstrate their commitment to quality assurance.

3. Sourcing Considerations

a. Purity and Specification Compliance

The API must meet specifications such as assay (generally ≥ 99%), pH, residual solvents, heavy metals, microbial limits, and endotoxin levels.

b. Batch Traceability and Certification

Documentation, including Certificates of Analysis (CoA), Compliance Certificates, and stability data, ensures transparency and traceability, critical for regulatory submissions.

c. Supply Chain Reliability

Disruption risks in Chinese and Indian supply chains have prompted many pharmaceutical companies to diversify providers or establish collaboration agreements with multiple suppliers.

4. Trends and Market Dynamics

The increasing demand for Edetate Calcium Disodium API is driven by expanding applications in chelation therapy, food safety, and industrial processes. Market competition prompts suppliers to invest in process improvements, quality certifications, and regional expansions to secure market share.

Regulatory agencies are increasingly scrutinizing API quality, emphasizing Good Manufacturing Practices (GMP) and compliance with pharmacopoeial standards. Asia remains the dominant sourcing region due to cost advantages, but European and North American suppliers often command premium pricing for certified quality.

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Supply Chain Challenges and Risk Management

• Regulatory Divergence: Variability in quality standards and documentation requirements across regions necessitates supplier audits and validation.
• Quality Assurance: Ensuring API purity, stability, and absence of contaminants demands rigorous testing and supplier qualification processes.
• Capacity Constraints: Global demand surges can lead to shortages, emphasizing the importance of multi-source procurement strategies.
• Intellectual Property and Regulatory Approvals: Collaboration with suppliers experienced in navigating regulatory landscapes accelerates approval processes.

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Conclusion

Global sourcing of Edetate Calcium Disodium API involves balancing quality, regulatory compliance, supply reliability, and cost. Chinese and Indian manufacturers dominate the supply landscape, offering cost-effective, high-quality options when certified appropriately. Europe and North American suppliers provide premium, GMP-compliant APIs favored by highly regulated markets. Strategic supplier qualification, rigorous quality assurance, and diversification mitigate risks associated with supply disruptions and regulatory hurdles.

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Key Takeaways

• Diverse Supplier Base: Chinese and Indian manufacturers are primary sources, with European and North American companies providing premium, certified APIs.
• Regulatory Compliance: Ensuring suppliers meet pharmacopoeial standards and possess requisite certifications is critical for pharmaceutical applications.
• Quality Assurance: Verification of batch-specific documentation, purity, and stability data ensures API suitability and regulatory acceptance.
• Supply Chain Resilience: Diversification and proactive supplier qualification reduce risks of shortages and compliance issues.
• Emerging Trends: Increasing demand and regulatory scrutiny underscore the importance of GMP standards and ongoing quality improvements in sourcing strategies.

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FAQs

1. What are the main applications of Edetate Calcium Disodium API?
Primarily used in chelation therapy for heavy metal poisoning, food preservation, cosmetics, and industrial applications requiring metal ion chelation.

2. How can manufacturers ensure the quality of Edetate Calcium Disodium API?
By sourcing from GMP-certified suppliers, verifying Certificates of Analysis, performing independent testing, and conducting supplier audits.

3. Which regions are leading in Edetate Calcium Disodium API production?
China and India dominate in manufacturing volume, with Europe and North America focusing on high-regulatory-standard supplies.

4. What are the critical quality specifications to consider when sourcing Edetate Calcium Disodium?
Assay purity (≥99%), low residual solvents, compliance with pharmacopoeial standards, microbial limits, and endotoxin levels.

5. What are the main challenges in sourcing Edetate Calcium Disodium API?
Supply chain disruptions, regulatory variability, ensuring consistent quality, and maintaining traceability and documentation.

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Sources

1. USP Monograph for EDTA Disodium Calcium Salt, United States Pharmacopeia, 2022.
2. European Pharmacopoeia, EDTA Disodium Calcium Salt, 11th Edition.
3. Chinese Pharmacopoeia Commission, Edetate Disodium Calcium Specification, 2020.
4. "Global Chelating Agents Market Outlook," MarketsandMarkets, 2022.
5. Regulatory & Quality Certification Guidelines, WHO and ICH Standards.