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

EDETATE CALCIUM DISODIUM SUPPLY CHAIN ANALYSIS

Last updated: February 19, 2026

This report analyzes the global supply chain for Edetate Calcium Disodium (CaNa2EDTA), a chelating agent used primarily for treating heavy metal poisoning. Key suppliers, manufacturing processes, and market dynamics are examined to inform R&D and investment decisions.

WHO ARE THE PRIMARY MANUFACTURERS OF EDETATE CALCIUM DISODIUM?

Global production of Edetate Calcium Disodium is concentrated among a limited number of manufacturers, primarily in Asia. These entities produce the active pharmaceutical ingredient (API) and its finished dosage forms.

• Key API Manufacturers:

  • China: Several Chinese pharmaceutical chemical companies produce CaNa2EDTA API. These include companies that focus on API synthesis for both domestic and international markets. Specific company names and production capacities are often proprietary but are typically found through direct sourcing inquiries and specialized chemical supplier databases.
  • India: The Indian pharmaceutical industry also contributes to CaNa2EDTA API production. Indian manufacturers are known for their cost-effectiveness and adherence to international quality standards, including Good Manufacturing Practices (GMP).
  • Europe: While less prominent than Asian manufacturers, some European chemical synthesis companies may produce CaNa2EDTA, often for niche applications or specialized quality requirements.

• Key Finished Dosage Form (FDF) Manufacturers:

  • United States: Major pharmaceutical companies in the U.S. formulate and distribute CaNa2EDTA as an injectable solution. These companies often source their API from international suppliers.
  • Europe: Similar to the U.S., European pharmaceutical firms are involved in the formulation and distribution of CaNa2EDTA.
  • Asia: Manufacturers in China and India also produce finished drug products for their respective domestic markets and for export.

The specific identities of FDF manufacturers often depend on regional regulatory approvals and distribution agreements. Market research reports and pharmaceutical distributors are primary sources for identifying these entities.

WHAT ARE THE KEY MANUFACTURING PROCESSES FOR EDETATE CALCIUM DISODIUM?

The synthesis of Edetate Calcium Disodium involves a multi-step chemical process, typically starting with ethylenediamine and formaldehyde, followed by reaction with sodium cyanide and subsequent chelation with calcium and sodium salts.

• Raw Material Sourcing:

  • Ethylenediamine: A basic organic compound, widely available from petrochemical suppliers.
  • Formaldehyde: Also a common industrial chemical.
  • Sodium Cyanide: Requires specialized handling and sourcing due to its toxicity.
  • Calcium Chloride & Sodium Hydroxide: Commodity chemicals.

• Synthesis Steps:

  1. Formation of EDTA Precursor: Ethylenediamine reacts with formaldehyde and sodium cyanide (Strecker synthesis variant) to form ethylenediaminetetraacetonitrile. This intermediate is then hydrolyzed under acidic or alkaline conditions to produce ethylenediaminetetraacetic acid (EDTA).
  2. Neutralization and Salt Formation: EDTA is then neutralized using a controlled addition of sodium hydroxide and calcium chloride to form the disodium calcium salt. Precise pH control and stoichiometric ratios are critical to achieve the desired CaNa2EDTA.
  3. Purification: The crude product undergoes purification steps, which may include crystallization, filtration, and drying to meet pharmaceutical-grade specifications. Impurity profiling is crucial to remove residual reactants, byproducts, and heavy metals.

• Quality Control:

  • Assay: Spectrophotometric or titrimetric methods confirm the concentration of CaNa2EDTA.
  • Impurities: High-performance liquid chromatography (HPLC) and gas chromatography (GC) are used to detect and quantify related substances, residual solvents, and heavy metals.
  • Physical Properties: Tests for pH, solubility, appearance, and particulate matter ensure product consistency.
  • Sterility & Endotoxins: For injectable formulations, stringent testing for sterility and bacterial endotoxins is mandatory.

Manufacturers must adhere to GMP guidelines established by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

WHAT ARE THE CRITICAL RAW MATERIALS AND THEIR AVAILABILITY?

The availability and cost of critical raw materials directly impact the production economics and supply security of Edetate Calcium Disodium.

• Ethylenediamine: Generally abundant and produced on a large industrial scale by major chemical conglomerates. Supply is typically stable, with price fluctuations linked to petrochemical feedstock costs.
• Formaldehyde: A high-volume industrial chemical, readily available from numerous global suppliers. Supply is robust.
• Sodium Cyanide: This is a more controlled raw material due to its toxicity. Production is concentrated among specialized chemical manufacturers. Supply chain risks can arise from production disruptions, transportation regulations, and environmental compliance costs. Sourcing requires careful vendor qualification and risk assessment.
• Calcium Chloride & Sodium Hydroxide: These are commodity chemicals with broad availability from multiple global producers. Supply is generally stable and cost-effective.

Supply Chain Risks:

• Geopolitical Instability: Production of raw materials, particularly sodium cyanide, may be concentrated in regions subject to political or economic instability, impacting supply.
• Environmental Regulations: Increasingly stringent environmental regulations in chemical manufacturing can lead to increased production costs or temporary shutdowns, affecting availability.
• Transportation and Logistics: The hazardous nature of some raw materials (e.g., sodium cyanide) imposes strict transportation regulations and can lead to logistical challenges.
• Supplier Concentration: A limited number of suppliers for key intermediates like sodium cyanide can create single-source dependencies.

Companies relying on CaNa2EDTA production often maintain diversified supplier bases for critical raw materials or establish long-term supply agreements to mitigate these risks.

WHAT ARE THE MAJOR MARKET DRIVERS AND CHALLENGES FOR EDETATE CALCIUM DISODIUM?

The market for Edetate Calcium Disodium is primarily driven by its established use in treating heavy metal poisoning, particularly lead poisoning. However, it faces competition and regulatory hurdles.

• Market Drivers:

  • Prevalence of Heavy Metal Poisoning: Persistent cases of lead poisoning, particularly in older housing stock and certain industrial settings, sustain demand for effective antidotes. Childhood lead exposure remains a public health concern in many regions.
  • Established Treatment Protocol: CaNa2EDTA is a well-recognized and effective treatment option for lead and other heavy metal intoxications (e.g., plutonium, radium). Its efficacy is supported by decades of clinical use.
  • Veterinary Applications: CaNa2EDTA is also used in veterinary medicine for treating metal toxicity in animals.
  • Emergency Preparedness: CaNa2EDTA is a component of strategic national stockpiles for potential mass casualty events involving heavy metal exposure.

• Market Challenges:

  • Alternative Therapies: For certain heavy metal intoxications, alternative chelating agents may offer different efficacy profiles or side-effect advantages. For example, succimer (DMSA) is often preferred for oral lead poisoning management in children.
  • Adverse Effects: CaNa2EDTA can cause nephrotoxicity, electrolyte imbalances, and other side effects, requiring careful patient monitoring during administration. This limits its use to severe cases or when other options are unsuitable.
  • Intravenous Administration: The requirement for intravenous administration can be a barrier compared to oral therapies, impacting patient convenience and requiring clinical settings.
  • Generic Competition: As a mature product, CaNa2EDTA faces significant generic competition, leading to price pressures on manufacturers.
  • Regulatory Scrutiny: Pharmaceutical products are subject to ongoing regulatory review. Any new safety concerns or changes in manufacturing standards can impact market access.
  • Limited New Indications: There is limited research into new therapeutic indications for CaNa2EDTA, suggesting a mature market with low growth potential from novel applications.

The market is thus characterized by stable, albeit niche, demand driven by its therapeutic role, countered by challenges from alternative treatments and the inherent limitations of the drug itself.

HOW DO GLOBAL REGULATORY LANDSCAPES IMPACT EDETATE CALCIUM DISODIUM SUPPLY?

Regulatory compliance is paramount for all pharmaceutical ingredients and finished products, significantly influencing manufacturing standards, market access, and supply chain operations for Edetate Calcium Disodium.

• Key Regulatory Bodies:

  • U.S. Food and Drug Administration (FDA): Oversees drug approval, manufacturing practices (cGMP), and quality standards in the United States.
  • European Medicines Agency (EMA): Regulates pharmaceuticals in the European Union, setting standards for quality, safety, and efficacy.
  • Pharmaceuticals and Medical Devices Agency (PMDA) in Japan: The Japanese regulatory authority for drug approval.
  • Other National Regulatory Agencies: Each country has its own health authority (e.g., Health Canada, Therapeutic Goods Administration (TGA) in Australia) that governs drug importation and sales.

• Impact on API Manufacturing:

  • Good Manufacturing Practices (GMP): API manufacturers must demonstrate strict adherence to GMP. This includes robust quality management systems, validated manufacturing processes, comprehensive documentation, and stringent impurity control. Facilities are subject to regular inspections by regulatory authorities.
  • Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. These confidential documents detail the manufacturing process, facilities, and quality controls. Pharmaceutical companies referencing a DMF for their finished product rely on its approval by the agency.
  • Import/Export Regulations: International trade of APIs requires compliance with import/export controls, including proper labeling, documentation, and adherence to any specific country requirements for controlled substances or hazardous materials.

• Impact on Finished Dosage Form (FDF) Manufacturing:

  • Marketing Authorization: FDFs require marketing authorization from relevant national agencies before they can be sold. This involves submitting dossiers demonstrating safety, efficacy, and quality, often referencing approved APIs.
  • Labeling and Packaging: Regulations dictate precise labeling requirements, including dosage, indications, contraindications, warnings, and expiry dates. Packaging must ensure product stability and integrity.
  • Pharmacovigilance: Post-market surveillance for adverse events is mandatory. Manufacturers must have systems in place to collect, analyze, and report adverse drug reactions.
  • Supply Chain Security: Regulations increasingly focus on the security and integrity of the pharmaceutical supply chain, including measures against counterfeiting and diversion.

• Regional Variations:

  • European Union: Requires Certificates of Suitability (CEP) from the European Directorate for the Quality of Medicines & HealthCare (EDQM) for APIs used in medicines authorized in member states, in addition to GMP compliance.
  • United States: FDA utilizes its own inspection system and reviews DMFs for APIs.
  • Emerging Markets: Regulatory frameworks in emerging markets can vary significantly in their stringency, sometimes posing challenges for global manufacturers seeking broad market access.

Compliance costs associated with meeting these diverse regulatory demands are substantial and represent a significant barrier to entry for new manufacturers and a continuous operational cost for existing ones. Changes in regulatory guidance or interpretations can necessitate costly process modifications or re-validations.

WHAT ARE THE KEY GEOGRAPHICAL MARKETS FOR EDETATE CALCIUM DISODIUM?

The geographical distribution of Edetate Calcium Disodium demand is closely tied to factors such as public health initiatives, industrialization levels, and healthcare infrastructure.

• North America (United States, Canada): Represents a significant market due to well-established healthcare systems, robust pharmacovigilance, and ongoing efforts to address lead poisoning, particularly in urban environments and older housing stock. Government stockpiles also contribute to demand.
• Europe: Similar to North America, European countries with advanced healthcare infrastructure and regulatory oversight constitute key markets. Demand is driven by clinical use in hospitals and specialized treatment centers.
• Asia-Pacific (China, India, Japan): This region shows considerable market potential.
  • China: With its large population and industrial base, China is a major producer and consumer. Demand is influenced by environmental regulations and public health campaigns.
  • India: A significant producer of APIs and finished formulations, India also has a substantial domestic market and is a key exporter.
  • Japan: A mature market with high regulatory standards, contributing stable demand.
• Latin America: Growing healthcare expenditure and increasing awareness of environmental health issues contribute to market growth. Regulatory frameworks are evolving, impacting product availability.
• Middle East & Africa: Demand in these regions is often driven by specific public health programs addressing heavy metal exposure, though healthcare infrastructure can be a limiting factor.

Market penetration is dependent on obtaining regulatory approvals in each jurisdiction and establishing effective distribution networks. Pricing strategies must also account for regional economic conditions and the competitive landscape.

WHAT IS THE COMPETITIVE LANDSCAPE FOR EDETATE CALCIUM DISODIUM?

The competitive landscape for Edetate Calcium Disodium is characterized by a mix of API manufacturers, finished dosage form producers, and the presence of alternative therapeutic agents.

• API Manufacturers:

  • Limited Number of Key Producers: Production of high-quality CaNa2EDTA API is concentrated among a few specialized chemical companies, primarily in China and India. These companies compete on price, quality, regulatory compliance (e.g., GMP certification, DMF availability), and reliability of supply.
  • Barriers to Entry: Significant capital investment, strict regulatory compliance, and established relationships with FDF manufacturers create high barriers to entry for new API producers.

• Finished Dosage Form (FDF) Manufacturers:

  • Generic Market: The majority of CaNa2EDTA is sold as a generic product. Numerous pharmaceutical companies globally formulate and market injectable CaNa2EDTA. Competition here is largely based on price, distribution network strength, and customer service to healthcare providers.
  • Branded vs. Generic: While there might have been historical branded products, the market is now predominantly generic.

• Competition from Alternative Therapies:

  • Succimer (DMSA): Oral DMSA is often preferred for less severe or chronic lead exposure, especially in children, due to its oral administration and potentially better side-effect profile in certain contexts. This directly competes with CaNa2EDTA, particularly in outpatient settings.
  • Other Chelating Agents: Depending on the specific heavy metal, other chelating agents like deferoxamine (for iron overload), dimercaprol (BAL), or penicillamine might be considered in specific clinical scenarios, although CaNa2EDTA's niche is well-defined for lead, plutonium, and radium.

• Strategic Considerations for Competitors:

  • Cost Efficiency: Continuous optimization of manufacturing processes to reduce costs is essential for survival in the generic API and FDF markets.
  • Regulatory Expertise: Maintaining a strong regulatory compliance record and supporting customer regulatory filings (e.g., DMFs) is a key differentiator.
  • Supply Chain Reliability: Ensuring a consistent and uninterrupted supply chain, from raw materials to finished product, is critical for customer retention.
  • Market Access and Distribution: Building and maintaining strong relationships with distributors, hospitals, and clinics is vital for market penetration and sales volume.

The competitive environment necessitates a focus on operational efficiency, stringent quality control, and a deep understanding of regulatory requirements to maintain market position.

KEY TAKEAWAYS

• Global Edetate Calcium Disodium (CaNa2EDTA) API production is concentrated among a limited number of manufacturers, primarily in China and India.
• Manufacturing involves a multi-step chemical synthesis requiring careful control of raw materials, particularly sodium cyanide, and adherence to stringent pharmaceutical-grade specifications.
• Market demand is driven by established treatments for heavy metal poisoning, notably lead poisoning, and supported by veterinary applications and emergency preparedness stockpiles.
• Competition from alternative chelating agents like succimer (DMSA), along with CaNa2EDTA's intravenous administration requirement and potential side effects, presents significant market challenges.
• Navigating diverse global regulatory landscapes (FDA, EMA, etc.), including GMP compliance and DMF submissions, is a critical and costly aspect of the supply chain.
• Key geographical markets include North America and Europe, with significant and growing potential in the Asia-Pacific region.
• The competitive landscape is primarily generic, with competition focused on cost-efficiency, supply chain reliability, and regulatory compliance.

FREQUENTLY ASKED QUESTIONS

1. Which countries are the largest exporters of Edetate Calcium Disodium API? China and India are the primary exporters of Edetate Calcium Disodium API.

2. What is the typical shelf-life for injectable Edetate Calcium Disodium formulations? Injectable formulations typically have a shelf-life of 24 to 36 months when stored under recommended conditions, but this can vary by manufacturer and specific formulation.

3. Are there any shortages of Edetate Calcium Disodium reported globally? While not a commonly reported drug for widespread shortages like some high-demand generics, localized or temporary supply disruptions can occur due to raw material availability or manufacturing issues.

4. What are the primary quality concerns for manufacturers of Edetate Calcium Disodium? Key quality concerns include controlling residual solvents, heavy metal impurities, related substances, and ensuring the correct calcium to disodium ratio for efficacy and safety.

5. How does the cost of Edetate Calcium Disodium compare to alternative treatments for lead poisoning? As a generic injectable, the API cost for CaNa2EDTA is generally competitive. However, the overall cost of treatment for lead poisoning is influenced by the route of administration, clinical setting, monitoring required, and the specific alternative therapy used, such as oral succimer.

CITATIONS

[1] U.S. Food and Drug Administration. (n.d.). Guidance for Industry. Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidance-industry [2] European Medicines Agency. (n.d.). Scientific Guidelines. Retrieved from https://www.ema.europa.eu/en/scientific-research/scientific-guidelines [3] World Health Organization. (2015). Guidelines for the prevention of lead poisoning. Retrieved from https://www.who.int/publications/i/item/9789241549100 [4] Agency for Toxic Substances and Disease Registry. (2021). Lead Toxicity. Retrieved from https://www.atsdr.cdc.gov/toxprofiles/tp13.pdf [5] U.S. Pharmacopeia. (n.d.). USP-NF Online. Retrieved from https://online.uspnf.com/