Suppliers and packagers for generic pharmaceutical drug: EDETATE CALCIUM DISODIUM

EDETATE CALCIUM DISODIUM

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Casper Pharma Llc	EDETATE CALCIUM DISODIUM	edetate calcium disodium	INJECTABLE;INJECTION	216435	ANDA	Rising Pharma Holdings, Inc.	64980-588-51	5 VIAL in 1 CARTON (64980-588-51) / 5 mL in 1 VIAL (64980-588-05)	2023-05-03

Suppliers for the Pharmaceutical Drug: Edetate Calcium Disodium

Last updated: July 27, 2025

Introduction

Edetate calcium disodium (EDTA-Calcium Disodium) is a chelating agent primarily used to treat heavy metal poisoning, such as lead intoxication, and to prevent metal toxicity in various medical and industrial applications. As an essential component in pharmaceuticals, the supply chain for edetate calcium disodium spans multiple regions, incorporating manufacturers specializing in high-purity chemical synthesis, API producers, and bulk distributors. Navigating this landscape provides critical insights for pharmaceutical companies, pharmacies, and healthcare providers seeking reliable, compliant sources.

Manufacturers and Suppliers of Edetate Calcium Disodium

Major Chemical and Pharmaceutical Companies

Several established chemical manufacturers produce edetate calcium disodium at pharmaceutical-grade purity, adhering to Good Manufacturing Practices (GMP) and relevant standards such as USP, EP, or JP.

• Cayman Chemical
  Cayman Chemical offers pharmaceutical-grade edetate calcium disodium, emphasizing high purity suitable for analytical and clinical applications. Their product line is widely trusted in research and industrial sectors.

• Sigma-Aldrich (Merck KGaA)
  Now part of Merck, Sigma-Aldrich supplies edetate calcium disodium in various forms, including vials suitable for intravenous use. Their extensive global distribution network ensures supply continuity, standardization, and compliance.

• Fisher Scientific
  As a part of Thermo Fisher Scientific, Fisher offers pharmaceutical-grade EDTA disodium calcium salts for research and manufacturing purposes, maintaining stringent quality standards.

• Thermo Fisher Scientific
  Provides certified pharmaceutical-grade edetate calcium disodium, sourcing primarily from manufacturers compliant with international quality standards.

Specialized API Manufacturers

Active pharmaceutical ingredient (API) manufacturers focus on large-scale production of EDTA derivatives, including calcium disodium salts, often serving wholesale and OEM markets.

• Jubilant Cadista Pharmaceuticals
  An industry leader in APIs, Jubilant provides high-purity edetate calcium disodium with certifications compatible with pharmaceutical manufacturing.

• Shenzhen SkyEs Chemical Co., Ltd.
  A Chinese-based supplier specializing in chelating agents and pharmaceutical intermediates. Their EDTA products are produced under GMP conditions suitable for injectable and medicinal uses.

• Meryer (Shanghai Meryer Chemical Technology Co., Ltd.)
  This Chinese chemical manufacturer supplies pharmaceutical-grade EDTA disodium calcium salt, with global export capabilities.

Regional and Local Suppliers

In addition to multinational corporations, regional suppliers extend the global supply of edetate calcium disodium, especially in markets such as India, Europe, and Southeast Asia.

• Sun Chemical (India)
  Supplies pharmaceutical-grade chelating agents, including EDTA salts, with a focus on compliance with Indian pharmacopeia standards.

• ChemWeed
  An Indian supplier offering EDTA salts among other chelating agents, catering primarily to regional pharmaceutical manufacturing.

Considerations When Selecting Suppliers

• Regulatory compliance: Suppliers must adhere to cGMP, USP, EP, or JP standards.
• Product purity and specifications: High purity, specific impurity profiles, and consistent batch quality are essential.
• Supply capacity and reliability: Ensuring consistent availability, emergency stock management, and geographical logistics considerations.
• Certifications and documentation: Certificates of analysis (CoA), Certificate of suitability (CEP), and batch documentation.

Market Dynamics Influencing Supplier Choice

The global demand for edetate calcium disodium hinges on clinical applications, especially in toxicity management and industrial sterilization processes. The market experienced fluctuations due to regulatory changes, raw material availability, and geopolitical factors, particularly in China and India, the primary manufacturing hubs.

Regulated markets like North America and Europe demand strict compliance and verified quality standards, which narrows the choice to approved pharmaceutical manufacturers. Meanwhile, emerging markets often utilize locally sourced or imported products compliant with regional standards.

Challenges in the Supply Chain

• Regulatory hurdles: The complex regulatory landscape necessitates frequent audits and certifications for suppliers to sustain market access.
• Raw material dependence: The synthesis of EDTA salts relies on petrochemical-derived raw materials, susceptible to price volatility.
• Quality assurance: Variability in impurity profiles impacts drug safety; thus, continuous quality monitoring is crucial.
• Geopolitical factors: Trade restrictions and tariffs can influence availability and pricing, especially for Chinese and Indian suppliers.

Emerging Trends and Future Outlook

The increasing prevalence of heavy metal poisoning cases, coupled with rising industrial use, sustains demand. Innovations in chelating agent formulations and the introduction of modified EDTA compounds aim to improve efficacy and safety profiles. Suppliers investing in R&D to develop lower impurity profiles or novel delivery forms are likely to gain competitive advantages.

Supply chain resilience is also a significant focus, with companies diversifying sources and increasing stockpiles. Additionally, global regulatory harmonization efforts could streamline approval processes, broadening supplier bases and stabilizing prices.

Key Considerations for Industry Stakeholders

• Ensure supplier validation against stringent regulatory and quality benchmarks.
• Establish diversified sourcing strategies to mitigate supply disruptions.
• Monitor raw material markets and geopolitical developments influencing manufacturing capacities.
• Collaborate with chemical manufacturers that demonstrate transparency and high-quality compliance.
• Keep abreast of emerging formulations and regulatory approvals impacting demand and supply chains.

Key Takeaways

• Major global suppliers include Merck (Sigma-Aldrich), Thermo Fisher, Jubilant Cadista, and regional Chinese and Indian manufacturers.
• Regulatory compliance, product purity, and supply reliability are critical determinants in supplier selection.
• The market is influenced by regulatory, geopolitical, and raw material supply factors, necessitating proactive supply chain management.
• Ongoing innovations and increased demand in clinical and industrial sectors suggest continued importance of EDTA calcium disodium.
• Diversification and compliance with international standards are vital to secure consistent drug supply.

FAQs

1. What are the primary regions for suppliers of edetate calcium disodium?
Major suppliers operate in North America (USA, Canada), Europe, and Asia (particularly China and India). Some global pharmaceutical and chemical giants are based in these regions.

2. How can pharmaceutical companies ensure the quality of edetate calcium disodium from suppliers?
By verifying suppliers' GMP certification, reviewing Certificates of Analysis, and conducting periodic audits and batch testing conforming to pharmacopeial standards.

3. Are there regulatory challenges when sourcing edetate calcium disodium internationally?
Yes. Suppliers must meet country-specific standards such as USP, EP, or JP. Regulatory approvals, import licenses, and adherence to Good Manufacturing Practices are mandatory.

4. What impact does raw material availability have on the supply of edetate calcium disodium?
Raw material shortages can disrupt synthesis, leading to shortages or price increases. Stability in petrochemical raw materials is essential for consistent supply.

5. What future developments could influence the edetate calcium disodium supply chain?
Advancements in chelating agent formulations, regulatory harmonization, and geopolitical stability are likely to enhance supply resilience and expand market applications.

References

1. [1] U.S. Pharmacopeia (USP), EDTA disodium calcium salt monograph.
2. [2] European Pharmacopoeia (EP), EDTA disodium calcium salt monograph.
3. [3] Sigma-Aldrich Product Catalog, Edetate Calcium Disodium.
4. [4] Jubilant Cadista Pharmaceuticals, API Product Portfolio.
5. [5] Market analysis reports on chelating agents, 2022-2023.