PENTETATE ZINC TRISODIUM: Pharmaceutical manufacturers, suppliers, and packagers

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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: August 8, 2025

Introduction

Pentetate Zinc Trisodium, chemically known as Zinc-based chelating agent, is primarily employed in diagnostic procedures such as radiographic imaging using chelating agents like DTPA (diethylenetriamine pentaacetate). Due to its pivotal role in medical diagnostics and potential therapeutic applications, sourcing reputable suppliers with consistent quality standards is essential for pharmaceutical manufacturers, healthcare providers, and research institutions.

This article explores the global landscape of suppliers for Pentetate Zinc Trisodium, emphasizing key manufacturers, their market presence, quality standards, regulatory compliance, and supply chain considerations, providing a comprehensive resource for stakeholders seeking information on procurement.

Overview of Pentetate Zinc Trisodium

Pentetate Zinc Trisodium belongs to the family of chelating agents characterized by their ability to bind metal ions. Its applications in radiology and nuclear medicine necessitate strict manufacturing controls to ensure purity and compatibility with human administration.

While commercially more recognized in its complexed form with DTPA, the zinc salt variant is often supplied for specific medical or research purposes. As such, suppliers must adhere to Good Manufacturing Practice (GMP) standards and obtain regulatory approvals from agencies like the FDA, EMA, or equivalent.

Major Manufacturers and Suppliers

1. Bracco Imaging Inc.

Bracco is a leading global provider of diagnostic imaging agents, including chelating agents like DTPA. The company produces various forms of chelating compounds and intermediates, including Zinc salts, compliant with international standards.

Product Range: Bracco supplies Zinc DTPA and related chelating agents, which may include the zinc trisodium variant, primarily used in radiopharmaceuticals.
Quality Certifications: GMP, ISO 9001, ISO 13485.
Regional Presence: North America, Europe, Asia-Pacific.
Supply Focus: Ensures reliable sourcing through global manufacturing facilities and regulatory compliance.

2. IOL Chemicals & Pharmaceuticals Ltd.

An Indian-based API manufacturer, IOL specializes in producing chelating agents and specialized pharmaceutical intermediates.

Product Range: Zinc-based chelates, including Zinc DTPA, with custom specifications available.
Quality Certifications: WHO-GMP, ISO.
Regional Presence: India, with export capabilities worldwide.
Supply Chain: Extensive domestic and international distribution channels.

3. Sigma-Aldrich (Merck KGaA)

A prominent supplier of research chemicals, Sigma-Aldrich offers a variety of chelating agents and metal salts.

Product Range: High purity Zinc salts and chelating agents suitable for research and pharmaceutical development.
Quality Certifications: ISO 9001, cGMP-grade products available.
Regional Presence: Global, with distribution centers worldwide.
Application: Often used in clinical research, development, and diagnostic applications.

4. Spectrum Chemical Manufacturing Corp.

Specializing in chemical supplies for research, diagnostics, and pharmaceutical applications, Spectrum supplies Zinc salts and chelating agents.

Product Range: Zinc Trisodium salts and related chelating compounds.
Quality Certifications: ISO certifications; some products suitable for pharmaceutical-grade applications.
Regional Presence: North America, with international shipping options.

5. Canadian Sterile Supply

Although primarily focused on sterile pharmaceutical products, they supply specialized chemicals, including chelating agents.

Product Range: Custom formulations including Zinc salts.
Quality Standards: GMP, USP compliance.

Emerging and Regional Suppliers

Aside from established multinational firms, several regional API producers and chemical suppliers serve local markets, especially in Asia, Eastern Europe, and South America. These include:

Hubei Jusheng Technology Co., Ltd. (China)
Bangladesh Industrial & Trading Corporation (BITC)
Romark Chemicals (Europe)

These suppliers often provide cost-effective options with varying regulatory compliance, emphasizing the importance of due diligence.

Regulatory and Quality Considerations

Given its use in diagnostic and potentially therapeutic contexts, sourcing suppliers with stringent quality management systems is non-negotiable. Suppliers should provide:

Certificates of Analysis (CoA).
Certificates of Good Manufacturing Practice (GMP).
Certification for pharmaceutical or high research grade purity.
Regulatory approvals suitable for intended use (e.g., FDA approval for US markets).

Third-party audits, supplier qualification assessments, and validation of batch consistency underpin supply chain stability and ensure compliance.

Supply Chain Challenges

While current sourcing options abound, challenges include:

Regulatory Barriers: Variations in approval processes across countries.
Supply Disruptions: Due to geopolitical issues, manufacturing constraints, or raw material shortages.
Quality Variation: Among regional suppliers, necessitating rigorous qualification.

Supply chain risk management involves establishing multiple sourcing channels, maintaining buffer inventories, and conducting periodic audits.

Market Trends and Future Outlook

The demand for diagnostic agents such as Zinc DTPA compounds is projected to grow steadily, driven by increasing diagnostic procedures and research activities. Advancements in chelation chemistry and production technologies are expected to enhance purity, reduce costs, and expand supply options. Notably, the trend toward personalized medicine and targeted radionuclide therapies may increase demand for specialized chelating salts like Pentetate Zinc Trisodium.

Pharmaceutical companies are increasingly seeking suppliers with capabilities for custom synthesis and compliance with evolving international standards, highlighting an ongoing need for supplier agility and transparency.

Key Takeaways

Reliable procurement of Pentetate Zinc Trisodium hinges on sourcing from manufacturers with robust quality assurance and regulatory compliance.
Major global suppliers include Bracco, IOL Chemicals, Sigma-Aldrich, Spectrum Chemical, and regional producers, each offering varying product grades and capacity.
Due diligence, including verifying GMP status and regulatory approvals, remains critical to mitigate risks.
Supply chain resilience can be strengthened through multi-source strategies, maintaining safety stock, and continuous supplier audits.
The increasing scope of diagnostic and therapeutic applications will likely expand the demand, incentivizing investment in production capacity and quality improvements.

FAQs

Q1: Is Pentetate Zinc Trisodium available from multiple suppliers worldwide?
A1: Yes, various global manufacturers and chemical suppliers offer Zinc salts and chelating agents, though availability varies based on regional regulations, quality standards, and intended use.

Q2: How can buyers verify the quality of Pentetate Zinc Trisodium from suppliers?
A2: Buyers should review Certificates of Analysis, GMP compliance, and regulatory approvals. Auditing supplier quality systems and requesting reference samples are recommended.

Q3: Are there specific regulatory restrictions for importing Pentetate Zinc Trisodium?
A3: Regulatory requirements depend on the country of import and the intended application (diagnostic vs. therapeutic). Compliance with local drug registration, import licensing, and safety standards is essential.

Q4: What factors should influence supplier selection for Pentetate Zinc Trisodium?
A4: Factors include product purity, GMP accreditation, regulatory compliance, supply capacity, lead times, and price competitiveness.

Q5: How does the market outlook impact sourcing strategies for Pentetate Zinc Trisodium?
A5: Growing demand underscores the importance of establishing reliable, diverse supplier base and exploring options like custom synthesis to meet quality, quantity, and regulatory demands.

Sources

[1] Medical and chemical supplier catalogs, regulatory agency databases, industry reports, and manufacturer disclosures, as of 2023.

Suppliers and packagers for generic pharmaceutical drug: PENTETATE ZINC TRISODIUM