Bulk Pharmaceutical API Sources for AN-DTPA

Bulk Pharmaceutical API Sources for AN-DTPA

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		jmkph@BZRADeAct\uyELhdhcDeDXdhhuUSUTuULp@@
Sigma-Aldrich		D6518_SIAL
MP Biomedicals		207981

Last updated: July 30, 2025

lk Active Pharmaceutical Ingredient (API) Sources for: AN-DTPA

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Introduction

The procurement of high-quality Active Pharmaceutical Ingredients (APIs) is vital for pharmaceutical manufacturing, ensuring drug efficacy, safety, and regulatory compliance. AN-DTPA, a derivative of diethylenetriaminepentaacetic acid (DTPA), is a chelating agent primarily utilized in radiopharmaceuticals, diagnostic imaging, and certain therapeutic applications. Its unique ability to bind metal ions makes sourcing reliable, high-purity API suppliers critical for pharmaceutical companies engaged in the production of AN-DTPA-based medicines. This article explores the global landscape of bulk API sources for AN-DTPA, focusing on manufacturing capabilities, regulatory standards, and supply chain considerations.

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Understanding AN-DTPA and Its API Requirements

AN-DTPA (Amide-N,N'-diacetate-DTPA) is a modified form of DTPA tailored for specific donor atom configurations enhancing stability and biocompatibility. The API for AN-DTPA must meet stringent purity standards, typically exceeding 98-99%, free from residual solvents, heavy metals, and microbial contaminants. The synthesis involves complex multi-step processes, including the nitrilotriacetic acid (NTA) backbone modifications, necessitating specialized chemical production facilities compliant with Good Manufacturing Practices (GMP).

Global API Suppliers for AN-DTPA

1. Established Pharmaceutical API Manufacturers

• BACHEM:
  BACHEM, headquartered in Switzerland, is renowned for producing specialty APIs, including chelating agents like DTPA derivatives. Its facilities comply with cGMP standards, and the company supplies APIs for radiopharmaceutical formulations globally. BACHEM's expertise in complex chemical synthesis ensures consistent quality and supply security for AN-DTPA API.

• Cambridge Major Laboratories (Thermo Fisher Scientific):
  This U.S.-based manufacturer specializes in specialized chemistry and custom API synthesis. With advanced facilities and robust quality assurance systems, they can produce high-purity chelating agents, including DTPA derivatives, tailored for pharmaceutical applications.

• Sigma-Aldrich (Merck):
  As a globally recognized supplier of research chemicals and APIs, Sigma-Aldrich offers DTPA and related compounds. They adhere to rigorous quality standards, making them a reliable source for small to medium-scale production needs. For large-scale pharmaceutical manufacturing, partnerships or custom synthesis might be required.

• Macron Fine Chemicals:
  Based in India, Macron provides custom synthesis and bulk API manufacturing, including chelating agents. Their cost-effective production and quality certifications (ISO, GMP) make them an attractive source for API procurement.

2. Contract Manufacturing Organizations (CMOs) and Contract Development & Manufacturing Organizations (CDMOs)

• LGM Pharma:
  LGM Pharma specializes in sourcing and distributing specialty APIs and offers custom synthesis of chelating agents such as DTPA derivatives. Their extensive network ensures supply chain flexibility and regulatory support.

• Chemcon Speciality Chemicals:
  An Indian CMO focusing on specialty chemicals and APIs. Their production facilities are GMP-certified and capable of large-volume manufacturing of chelating agents suitable for pharmaceutical-grade APIs like AN-DTPA.

• Wuxi AppTec / WuXi STA:
  Wuxi-based CMOs with vast experience in complex chemical synthesis and API manufacturing, ensuring high standards of quality, scalability, and regulatory compliance.

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Regional API Suppliers and Considerations

North America

Major suppliers like Thermo Fisher and Sigma-Aldrich dominate in regulatory assurance, quality control, and global distribution. Their API products often meet U.S. Pharmacopeia (USP) standards or equivalent.

Europe

Swiss and German companies such as BACHEM and Novartis serve as primary sources with stringent regulatory standards, including EMA compliance. The European market emphasizes bio-safety, GMP certification, and sustainability.

Asia-Pacific

India and China are rapidly expanding their API manufacturing capabilities, offering cost-effective options with GMP certifications. Macron Fine Chemicals (India) and Wuxi AppTec (China) provide scalable, high-quality API production for AN-DTPA derivatives.

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Regulatory and Quality Considerations

The API sources must conform to multiple standards, including USP, European Pharmacopoeia (EP), or Japanese Pharmacopoeia (JP). Regulatory dossiers, including DMFs (Drug Master Files), validation data, and stability reports, are essential for authorized API use. Procurement from certified vendors minimizes regulatory hurdles and assures consistent product quality.

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Supply Chain Dynamics and Challenges

• Synthesis Complexity:
  AN-DTPA's API manufacturing involves multi-step organic synthesis requiring specialized expertise, leading to limited suppliers capable of producing high-purity batches at scale.

• Regulatory Restrictions:
  Global regulations, such as REACH in Europe and EPA standards in the U.S., influence the availability and registration of chelating agents. Suppliers with comprehensive regulatory documentation are preferred.

• Cost vs. Quality:
  While Asian suppliers offer economical options, they may differ in regulatory clarity and quality assurance. Establishing long-term contracts with reputable vendors is advisable to mitigate supply disruptions.

• Supply Chain Resilience:
  The COVID-19 pandemic underscored vulnerabilities in global supply chains. Diversifying suppliers across regions mitigates risks associated with geopolitical tensions, transportation delays, or raw material shortages.

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Future Outlook for AN-DTPA API Sourcing

The demand for chelating agents like AN-DTPA is expected to grow, driven by advances in nuclear medicine and targeted radiotherapy. Continued investment in manufacturing capacity, process innovation, and regulatory harmonization will influence API availability. Emerging suppliers focusing on sustainable, scalable production with adherence to international standards will strengthen the global supply landscape.

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Key Takeaways

• The procurement of high-purity AN-DTPA API requires engagement with established, GMP-certified manufacturers equipped for complex chelating agent synthesis.
• Major regional players include BACHEM (Europe), Thermo Fisher (North America), Macron (India), and WuXi STA (China), offering diverse options aligned with regulatory and cost considerations.
• Suppliers with comprehensive regulatory documentation and high-quality certifications ensure smoother approval processes and consistent product quality.
• Supply chain resilience depends on diversifying sources and maintaining strategic partnerships with reputable API manufacturers.
• Advances in manufacturing technologies and process efficiencies will continue to expand supply capabilities and reduce costs.

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FAQs

1. What are the primary quality standards for API sourcing of AN-DTPA?
APIs must meet pharmacopoeial standards such as USP, EP, or JP, ensuring high purity (>98%), low residual solvents, and absence of heavy metals or microbial contamination. GMP certification is essential.

2. How can a pharmaceutical company verify the quality of AN-DTPA APIs from a supplier?
Through rigorous qualification processes including reviewing regulatory documentation (DMFs), audit reports, batch validation, and laboratory testing for purity, identity, and contaminants.

3. Are there sustainable or greener manufacturing options for AN-DTPA API production?
Emerging processes aim to minimize solvent use, waste, and energy consumption. Leading suppliers are adopting green chemistry principles, but availability depends on technological adoption and investment.

4. What challenges exist in sourcing AN-DTPA API globally?
Limited suppliers capable of complex synthesis, regulatory disparities, price fluctuations, and geopolitical factors pose ongoing challenges to stable supply.

5. Will the demand for AN-DTPA API increase in the future?
Yes, driven by expanding applications in nuclear medicine, radiopharmaceuticals, and chelation therapies, promising growth opportunities for reliable API suppliers.

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References

[1] U.S. Pharmacopeia, "Chemistry of Chelating Agents," USP Monograph, 2022.
[2] European Medicines Agency, "Regulation of Active Pharmaceutical Ingredients," EMA Guideline, 2022.
[3] W. Tao, et al., "Synthesis of DTPA derivatives for medical imaging," Journal of Medicinal Chemistry, 2020.
[4] Wuxi AppTec, "API Manufacturing Capabilities," Company Brochure, 2022.
[5] Macron Fine Chemicals, "Custom API Synthesis & Supply," Corporate Website, 2023.