PENTETATE ZINC TRISODIUM: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hameln Pharma Plus	PENTETATE ZINC TRISODIUM	pentetate zinc trisodium	SOLUTION;INHALATION, INTRAVENOUS	021751	NDA	hameln pharma gmbh	70651-002-03	10 AMPULE in 1 PACKAGE (70651-002-03) / 5 mL in 1 AMPULE	2004-08-11
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report identifies and analyzes key suppliers of Pentetate Zinc Trisodium, a pharmaceutical compound used primarily in medical imaging and radionuclide therapy. The analysis focuses on supplier capacity, regulatory compliance, and potential for scale-up to inform strategic sourcing decisions.

What is Pentetate Zinc Trisodium?

Pentetate Zinc Trisodium, also known by the chemical name Zinc diethylenetriaminepentaacetic acid trisodium salt and often abbreviated as Zn-DTPA or Pentetate Calcium Trisodium [Ca-DTPA] when referring to its calcium analog, is a chelating agent. Its primary pharmaceutical application is as a radioprotective agent and as a chelator for removing radioactive heavy metals from the body, particularly in cases of accidental internal contamination with radioactive isotopes such as plutonium, americium, and curium. It functions by forming stable, soluble complexes with these metal ions, facilitating their excretion from the body.

In nuclear medicine, it is also used in certain diagnostic imaging procedures and in some therapeutic applications, though its use in diagnostic imaging is less common than its chelating role for decontamination. The compound's efficacy is dependent on its ability to bind strongly and selectively to target metal ions.

The synthesis of Pentetate Zinc Trisodium involves the production of Diethylenetriaminepentaacetic acid (DTPA), followed by its reaction with a zinc source and trisodium hydroxide under controlled conditions to form the desired salt. The purity and quality of the DTPA precursor are critical to the final product's efficacy and safety profile. Manufacturing requires adherence to strict Good Manufacturing Practices (GMP) to ensure product consistency and meet regulatory standards for pharmaceutical ingredients.

Who are the Primary Manufacturers of Pentetate Zinc Trisodium?

The manufacturing landscape for Pentetate Zinc Trisodium is specialized, with a limited number of companies possessing the technical expertise and regulatory approvals for pharmaceutical-grade production. The supply chain is not as broadly populated as for more common active pharmaceutical ingredients (APIs).

Key manufacturers and suppliers identified through patent analysis and industry databases include:

Mallinckrodt Pharmaceuticals: While historically a significant player in radiopharmaceuticals and contrast agents, their current specific offerings for Pentetate Zinc Trisodium require direct confirmation. Their expertise in complex chemical synthesis and radiolabeling positions them as a potential supplier or partner.
GE Healthcare: A major entity in medical imaging, GE Healthcare has a broad portfolio of contrast agents and radiopharmaceuticals. While their public product listings may not always explicitly detail Pentetate Zinc Trisodium, their extensive manufacturing and regulatory infrastructure makes them a potential source, particularly for formulations or specialized applications.
Curium Pharma (formerly IBA-MedCom): This company is a significant global provider of radiopharmaceuticals and related products. Their focus on nuclear medicine applications suggests a strong possibility of involvement in the supply chain for chelating agents like Pentetate Zinc Trisodium, either directly or through custom synthesis partnerships.
Specialty Chemical Manufacturers: Beyond the large pharmaceutical conglomerates, a segment of specialized chemical manufacturers focuses on producing complex organic compounds and APIs under contract. These firms often operate on a smaller scale but can offer flexibility and expertise in niche markets. Identifying these specific entities requires deeper investigation into contract manufacturing organizations (CMOs) with experience in chelation chemistry and GMP-compliant API production. For example, companies like Bachem or Lonza possess broad capabilities in API synthesis, although specific product lines need verification.

It is important to note that the market for Pentetate Zinc Trisodium is relatively niche compared to blockbuster APIs. Therefore, direct procurement often involves engaging with companies that specialize in radiopharmaceuticals, diagnostic agents, or custom API synthesis. Availability can also be influenced by the demand for specific therapeutic applications and the presence of approved drug products utilizing this compound.

What are the Regulatory Considerations for Pentetate Zinc Trisodium?

The production and supply of Pentetate Zinc Trisodium are subject to stringent regulatory oversight by health authorities globally, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Compliance with Good Manufacturing Practices (GMP) is paramount.

Key regulatory aspects include:

GMP Certification: Manufacturers must demonstrate adherence to current Good Manufacturing Practices (cGMP). This involves rigorous quality control, robust documentation, validated manufacturing processes, and established systems for change control, deviation management, and complaint handling. Facilities are subject to regular inspections by regulatory bodies.
Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. A DMF contains confidential, detailed information about the manufacturing process, facilities, packaging, and quality controls of the API. Pharmaceutical companies seeking to use the API in their drug products reference the DMF in their regulatory submissions (e.g., New Drug Applications - NDAs).
ICH Guidelines: Manufacturers are expected to comply with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, particularly those related to quality (e.g., ICH Q7 for APIs).
Impurity Profiling: Comprehensive analysis and control of impurities, including process-related impurities, residual solvents, and potential degradation products, are critical. Specifications for impurity levels must be established and met.
Stability Testing: Manufacturers must conduct extensive stability studies to determine the shelf life of the API under various storage conditions, ensuring its quality over time.
Traceability and Supply Chain Security: Robust systems for tracking raw materials and finished product batches are essential to ensure supply chain integrity and facilitate recalls if necessary.

For Pentetate Zinc Trisodium, specific regulatory filings may exist within the context of approved radiopharmaceutical products that utilize it as an active ingredient or excipient. Companies relying on this API must ensure their chosen supplier can provide the necessary documentation and quality assurance to support their own regulatory submissions and ongoing compliance.

What is the Current Market Landscape and Supply Chain Dynamics?

The market for Pentetate Zinc Trisodium is characterized by specialized demand and a concentrated supplier base. This dynamic influences pricing, lead times, and the potential for supply chain disruptions.

Niche Market: Demand for Pentetate Zinc Trisodium is primarily driven by its use in radioprotection and certain medical imaging/therapeutic applications. This makes it a lower-volume API compared to many other pharmaceuticals, leading to fewer dedicated large-scale manufacturers.
Limited Number of Producers: As outlined previously, the number of GMP-compliant manufacturers with demonstrated expertise in producing pharmaceutical-grade Pentetate Zinc Trisodium is limited. This can create reliance on a few key entities.
Geographic Concentration: Manufacturing may be concentrated in regions with established pharmaceutical and radiochemical industries, such as North America, Europe, and parts of Asia. This can create logistical considerations and potential geopolitical risks.
Pricing: Pricing is influenced by manufacturing complexity, regulatory compliance costs, and the relatively low volume of demand. Specialized synthesis and rigorous quality control contribute to higher per-unit costs compared to commodity chemicals.
Lead Times: Due to specialized production runs and limited inventory, lead times for securing significant quantities of Pentetate Zinc Trisodium can be substantial. Planning and forecasting are critical for procurement.
Custom Synthesis: In many cases, pharmaceutical companies may engage in custom synthesis agreements with CMOs, especially if they require specific purity profiles or quantities that exceed standard catalog offerings. This process involves detailed project scoping, process development, and validation.
Inventory and Stockpiling: Given the specialized nature and potential criticality of its applications (e.g., in emergency preparedness for radiation exposure), government agencies or large healthcare organizations may maintain strategic stockpiles of Pentetate Zinc Trisodium or related chelating agents.

The supply chain resilience for Pentetate Zinc Trisodium relies heavily on the stability and capacity of its limited manufacturing base. Any significant disruption at a key supplier – due to regulatory issues, operational problems, or geopolitical events – could have a material impact on availability.

What are the Key Technical and Quality Specifications?

The quality and technical specifications for pharmaceutical-grade Pentetate Zinc Trisodium are critical for its safe and effective use. These specifications are typically detailed in pharmacopoeial monographs (if available) and in the manufacturer's Certificate of Analysis (CoA).

Key specifications include:

Assay: The concentration of Pentetate Zinc Trisodium, typically expressed as a percentage by weight. This is determined through titrimetric or chromatographic methods and must fall within a defined range, e.g., 98.0% - 102.0%.
Identification: Tests to confirm the identity of the substance, often involving spectroscopic methods (e.g., Infrared Spectroscopy - IR) and chemical tests for zinc and the DTPA moiety.
Appearance: The physical form and color of the substance, e.g., a white to off-white crystalline powder.
Solubility: Its solubility in specified solvents, such as water.
pH: The pH of an aqueous solution of the substance, indicating its acidity or alkalinity.
Water Content: Determined by Karl Fischer titration, typically specified at a low percentage to ensure stability.
Heavy Metals: Limits for heavy metal contamination, which are critical for injectable or orally administered pharmaceuticals.
Related Substances/Impurities: Limits for specific known impurities and total impurities. This includes unreacted starting materials, by-products of synthesis, and degradation products. Techniques such as High-Performance Liquid Chromatography (HPLC) are used for this analysis.
Residual Solvents: Limits for solvents used during the manufacturing process, as defined by ICH Q3C guidelines. Gas Chromatography (GC) is commonly employed.
Microbial Limits: For APIs intended for sterile drug products, stringent microbial limit testing (bioburden) and testing for bacterial endotoxins are required.
Particle Size Distribution: May be specified for certain formulations to ensure consistent dissolution rates and processability.
Zinc Content: Specific testing to confirm the stoichiometry of zinc in the complex.

Manufacturers must validate their analytical methods and ensure that all testing is performed in a GMP-compliant laboratory. A comprehensive CoA accompanying each batch provides critical assurance to the end-user regarding compliance with these specifications.

What are the Potential Risks and Mitigation Strategies for Sourcing?

Sourcing Pentetate Zinc Trisodium carries specific risks due to its niche nature and specialized manufacturing requirements. Proactive risk management is essential for supply chain continuity.

Key Risks:

Single/Sole Source Dependence: Reliance on a single manufacturer for an API can create significant vulnerability. If that supplier experiences production issues, regulatory actions, or business closure, the supply chain can be severely disrupted.
Quality Variability: Inconsistent quality from a supplier can lead to rejected batches, manufacturing delays, and regulatory non-compliance. This is particularly critical for APIs requiring strict impurity profiles.
Supply Chain Disruptions: Geopolitical events, natural disasters, transportation issues, or raw material shortages impacting a supplier's operations can halt production.
Regulatory Non-Compliance: A supplier failing to maintain GMP standards or facing regulatory sanctions can render their API unusable for pharmaceutical applications.
Price Volatility: Limited competition can lead to price increases, impacting the cost-effectiveness of finished drug products.
Long Lead Times and Low Inventory: Difficulty in rapidly scaling up production or obtaining urgent shipments can be problematic for meeting unexpected demand surges.

Mitigation Strategies:

Supplier Diversification: Identify and qualify at least two independent GMP-compliant manufacturers if feasible. This provides redundancy and leverage in negotiations.
Robust Supplier Qualification Program: Implement a comprehensive program that includes site audits, review of quality systems, assessment of financial stability, and verification of regulatory compliance history.
Contractual Agreements: Establish clear supply agreements with defined quality specifications, delivery schedules, change control procedures, and business continuity clauses. Include provisions for force majeure.
Strategic Stockpiling: Maintain a strategic inventory of the API at your facility or through a third-party logistics provider. The size of the stock should be based on lead times, demand volatility, and criticality of the drug product.
Close Supplier Relationship and Communication: Foster strong communication channels with key suppliers to gain early insight into potential production issues or changes. Regular performance reviews are beneficial.
Second-Source Development: Proactively engage with potential alternative suppliers, even if not immediately needed. This reduces the time and effort required to qualify a new source during a crisis.
Geographic Diversification of Suppliers: If possible, source from suppliers located in different geographic regions to mitigate risks associated with localized events.
Regular Audits and Quality Monitoring: Conduct periodic re-audits of qualified suppliers and continuously monitor batch-to-batch quality through incoming goods testing.
Process Understanding and Transferability: For critical APIs, invest in understanding the manufacturing process sufficiently to facilitate technology transfer to a second site or manufacturer if necessary.

By implementing these strategies, pharmaceutical companies can build a more resilient and secure supply chain for Pentetate Zinc Trisodium, ensuring continuity of supply for essential medical treatments.

Key Takeaways

The market for Pentetate Zinc Trisodium is specialized and driven by niche pharmaceutical applications, primarily radioprotection and medical imaging.
Manufacturing is concentrated among a limited number of suppliers with demonstrated GMP compliance and expertise in complex organic synthesis.
Regulatory adherence to cGMP, ICH guidelines, and robust quality control systems are non-negotiable for any supplier.
Supply chain risks include single-source dependence, quality variability, and potential disruptions, necessitating diversification and robust supplier qualification.
Key technical specifications focus on assay, purity, impurity profiling, and physical characteristics, all verified through a Certificate of Analysis.
Mitigation strategies involve supplier diversification, strong contractual agreements, strategic stockpiling, and close communication with manufacturers.

Frequently Asked Questions

What is the primary application of Pentetate Zinc Trisodium in medicine? Pentetate Zinc Trisodium is primarily used as a chelating agent to remove radioactive heavy metals from the body, such as in cases of internal contamination with plutonium, americium, or curium, and for radioprotection. It also has applications in certain diagnostic imaging and therapeutic procedures.
Are there specific pharmacopoeial monographs for Pentetate Zinc Trisodium? Availability of specific pharmacopoeial monographs can vary by region. Manufacturers must meet USP (United States Pharmacopeia), EP (European Pharmacopoeia), or JP (Japanese Pharmacopoeia) standards if such monographs exist and are relevant to the intended market. If not, manufacturers must adhere to stringent internal specifications validated by regulatory agencies.
Can Pentetate Zinc Trisodium be manufactured by any custom synthesis company? While many custom synthesis companies can produce complex organic molecules, pharmaceutical-grade Pentetate Zinc Trisodium requires adherence to strict Good Manufacturing Practices (GMP). Only companies with established GMP-certified facilities and a proven track record in API manufacturing can reliably produce this compound for pharmaceutical use.
What is the typical shelf life for pharmaceutical-grade Pentetate Zinc Trisodium? The shelf life of pharmaceutical-grade Pentetate Zinc Trisodium is determined through rigorous stability testing performed by the manufacturer under controlled conditions. Typical shelf lives can range from 2 to 5 years, contingent on storage conditions and the specific formulation and packaging.
How can a company ensure the long-term availability of Pentetate Zinc Trisodium given the specialized market? Companies can ensure long-term availability by establishing multi-year supply agreements with qualified manufacturers, developing relationships with alternative or secondary suppliers, maintaining strategic inventory levels, and actively monitoring the regulatory and operational status of their key suppliers.

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.). Guidance documents. Retrieved from https://www.ema.europa.eu/en/documents/other/guideline-structure-quality-documentation-drug-product_en [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from https://www.ich.org/page/guidelines [4] United States Pharmacopeia. (n.d.). Pharmacopeial Forum. Retrieved from https://www.uspnf.com/pharmacopeial-forum [5] European Pharmacopoeia. (n.d.). About the European Pharmacopoeia. Retrieved from https://www.edqm.eu/en/about-european-pharmacopoeia

Suppliers and packagers for generic pharmaceutical drug: PENTETATE ZINC TRISODIUM