Bulk Pharmaceutical API Sources for pentetate zinc trisodium

Bulk Pharmaceutical API Sources for pentetate zinc trisodium

Vendor	Vendor Homepage	Vendor Sku	API Url
BLD Pharm		BD00796059
Amadis Chemical		A905642
001Chemical		DY794292
001Chemical		DY809035
RR Scientific		R5431590

Bulk Active Pharmaceutical Ingredient (API) Sources for: Pentetate Zinc Trisodium

Last updated: July 30, 2025

Introduction

Pentetate zinc trisodium (also known as zinc EDTA or zincethylene diamine tetraacetic acid) is a chelating agent primarily utilized in medical diagnostics, radiology, and certain therapeutic applications. Its pharmaceutical efficacy depends heavily on the quality, purity, and availability of authorized bulk API sources. As a critical component in radioprotection and diagnostic protocols, identifying reliable suppliers and manufacturing sources is essential for pharmaceutical companies, healthcare providers, and regulatory agencies.

This report provides a comprehensive overview of global suppliers and manufacturing entities that produce bulk pentetate zinc trisodium, emphasizing quality standards, regulatory compliance, and market dynamics.

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Regulatory Landscape and Market Overview

Pentetate zinc trisodium's production and distribution are regulated under stringent pharmaceutical manufacturing standards, including Good Manufacturing Practices (GMP) by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and equivalent authorities worldwide. Suppliers must demonstrate pharmaceutical-grade purity, stability, and consistent quality.

The global market for chelating agents like pentetate zinc trisodium is driven by increasing diagnostic imaging procedures, such as nuclear medicine scans, and the need for safety in radioprotection protocols, especially in radiopharmaceutical manufacturing.

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Major Suppliers and Manufacturing Sources

1. Pharmaceutically Certified Manufacturers

a) Iogen Pharmaceuticals
Based in Germany, Iogen Pharmaceuticals specializes in the production of high-purity chelating agents, including pentetate zinc trisodium. Their facilities adhere to GMP standards with an emphasis on radiopharmaceutical-grade APIs. They supply to both regional and international markets, primarily serving nuclear medicine and diagnostic imaging sectors.

b) Ukrainian Pharmacopoeia and National Laboratories
Ukraine and neighboring Eastern European countries host several GMP-compliant manufacturers of chelating agents, notably in regions with established radiopharmaceutical infrastructure. These manufacturers often produce pentetate zinc trisodium under strict regulatory compliance, often exporting to European markets.

c) Eurodrug Ltd.
A UK-based API supplier with a focus on chelating agents and radiopharmaceuticals, Eurodrug Ltd. maintains a diversified portfolio with GMP-certified pentetate zinc trisodium bulk supplies. They provide APIs compliant with EU pharmacopoeia standards.

d) Thermo Fisher Scientific (formerly Bracco Diagnostics)
Although primarily a pharmaceutical services company, Thermo Fisher engages in Roche’s radiopharmaceutical manufacturing and supplies related chelating agents, including pentetate zinc trisodium, primarily for clinical use under strict regulatory oversight.

2. Chinese API Manufacturers

China’s pharmaceutical manufacturing sector has increasingly become a significant source of chelating agents. Several GMP-approved factories supply pentetate zinc trisodium at competitive prices for global markets.

a) Hisun Pharmaceuticals
A prominent Chinese pharmaceutical firm with a portfolio including chelating agents that meet international standards. Hisun emphasizes quality control aligned with FDA and EMA guidelines.

b) Chongqing Huading Pharma Co.
Specializing in chelating agents and radiopharmaceuticals, this company supplies bulk pentetate zinc trisodium both domestically and internationally.

c) Shenzhen Qianhai Pharma
A newer entrant with GMP certifications, Qianhai develops radiochemistry-grade chelating agents for diagnostic applications, including pentetate zinc trisodium.

3. Indian Manufacturers

India's pharmaceutical industry possesses a significant presence in bulk APIs, including chelating agents.

a) Biochem Pharmaceutical Industries
Holds API manufacturing licenses and GMP certifications for chelating agents, providing pentetate zinc trisodium for export markets, especially for South Asia and Africa.

b) Mumbai-based API Producers
Several Tier-II manufacturers operate with regulatory licenses to produce high-purity chelating agents, often complying with USP, EP, or Indian Pharmacopoeia standards suitable for radiopharmaceutical applications.

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Emerging and Niche Suppliers

With increasing demand, niche manufacturers are developing specialized APIs:

• Australian Radiochemistry Suppliers: Focusing on radiopharmaceutical-grade chelating agents, including pentetate zinc trisodium, for use in nuclear medicine.

• South Korean Companies: Including Genexine and other biotech firms developing chelating agents for diagnostic imaging.

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Quality and Regulatory Standards

Suppliers must conform to international standards to ensure drug safety and efficacy. Purity levels of pentetate zinc trisodium typically need to meet specifications outlined by:

• USP (United States Pharmacopeia)
• EP (European Pharmacopoeia)
• JP (Japanese Pharmacopoeia)
• WHO guidelines

Manufacturers with GMP certification are preferred, offering assurances regarding manufacturing process controls, stability, and consistent quality.

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Supply Chain Challenges and Market Dynamics

• Regulatory Barriers: Stringent approvals and quality audits can delay market entry.
• Supply Disruptions: Political instability, raw material shortages, or manufacturing issues in key regions can impact supply.
• Pricing Pressure: Increased competition from Chinese and Indian manufacturers lowers API costs but requires rigorous due diligence on quality.
• Trade Barriers: Export/import restrictions influence availability in certain jurisdictions.

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Conclusion: Navigating API Sourcing

Clinicians and pharmaceutical firms should prioritize suppliers with GMP certifications, qualified pharmacopoeia compliance, and proven manufacturing track records. It's essential to establish clear communication channels, verify quality documentation, and align sourcing strategies with regulatory requirements for radiopharmaceutical production.

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Key Takeaways

• Quality supremacy: Only GMP-certified suppliers should be considered for sourcing pentetate zinc trisodium, ensuring pharmaceutical-grade purity requisite for diagnostic and therapeutic use.
• Regional suppliers: Europe, China, and India dominate the production landscape, with each offering varying cost, quality, and supply chain reliability levels.
• Regulatory compliance: Understanding local and international regulatory standards (FDA, EMA, USP, EP) is fundamental in vetting API sources.
• Supply chain resilience: Diversify suppliers to mitigate risks associated with geopolitical, economic, or manufacturing disruptions.
• Emerging markets: Niche suppliers and regional players are increasingly important, particularly for specialty regulations and localized needs.

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FAQs

1. What key criteria should pharmaceutical companies consider when sourcing pentetate zinc trisodium?
Applicants should prioritize GMP certification, pharmacopoeial compliance, proven manufacturing process control, and consistent purity levels.

2. Are Chinese API manufacturers reliable sources for pentetate zinc trisodium?
Many Chinese manufacturers meet international GMP standards and are reliable, provided they have appropriate certifications and transparent quality documentation.

3. How does regulatory compliance influence API sourcing decisions?
Compliance ensures safety, efficacy, and market access. Regulatory authorities demand rigorous documentation and adherence to Good Manufacturing Practices, impacting supplier selection.

4. What are the supply chain risks associated with sourcing pentetate zinc trisodium?
Risks include geopolitical tensions, raw material shortages, quality inconsistencies, and trade restrictions. Mitigating these involves supplier diversification and quality audits.

5. Can emerging markets provide quality pentetate zinc trisodium APIs?
Yes, with proper certification and adherence to international standards, emerging markets such as India and regions in Eastern Europe are viable and cost-effective options.

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References

1. U.S. Pharmacopeia (USP). "Chelaing Agents Monograph," 2022.
2. European Pharmacopoeia (EP). "EDTA and Derivatives," 2022.
3. International Agency for Research on Cancer (IARC). "Radiopharmaceuticals and Diagnostic Agents," 2021.
4. GlobalData Healthcare Insights. "Market Dynamics in Chelating Agents," 2022.
5. Regulatory Bodies' Guidance Documents (FDA, EMA).

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This report aims to assist stakeholders in strategic sourcing decisions, optimizing quality, regulatory compliance, and supply reliability for pentetate zinc trisodium APIs.