Bulk Pharmaceutical API Sources for diethylstilbestrol diphosphate

Bulk Pharmaceutical API Sources for diethylstilbestrol diphosphate

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		3032325
ABI Chem		AC1MHTX6
Aronis		ARONIS24369
ChemMol		80101524
AKos Consulting & Solutions		AKOS005267157

Bulk Active Pharmaceutical Ingredient (API) Sources for Diethylstilbestrol Diphosphate

Last updated: August 7, 2025

Introduction

Diethylstilbestrol diphosphate (DES diphosphate) is a synthetic non-steroidal estrogen historically used in hormone therapy and as a pharmaceutical agent. While its clinical applications have declined due to safety concerns, the API remains of interest for research, regulatory, or historical purposes. Procuring high-quality bulk APIs relies on identifying reliable suppliers with approved manufacturing standards, regulatory compliance, and consistent quality control processes.

This report explores current sources for bulk diethylstilbestrol diphosphate, including global pharmaceutical ingredient manufacturers, contract manufacturing organizations (CMOs), and suppliers specializing in hormonal and endocrine-related APIs. It emphasizes the importance of compliance with Good Manufacturing Practice (GMP), Quality Assurance (QA), and regulatory standards that ensure the integrity of the API for legal and safety reasons.

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Regulatory and Quality Considerations

When sourcing DES diphosphate, businesses must prioritize suppliers compliant with international standards such as GMP, ISO, and those approved by regulatory agencies like the FDA, EMA, or China's NMPA. Given the compound's toxicity and potential for misuse, rigorous quality control, thorough documentation, and validated supply chains are essential.

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Leading API Manufacturers and Suppliers

1. Global Pharmaceutical Ingredient Suppliers

Several large-scale API manufacturers dominate the market for hormonal and estrogenic compounds, including diethylstilbestrol derivatives. These companies often operate manufacturing facilities compliant with cGMP, providing bulk APIs for research and pharmaceutical applications.

• Cipla Limited (India):
  A prominent producer of hormonal APIs, Cipla offers diethylstilbestrol-based compounds. The company maintains strict quality standards and supplies APIs to global markets. While specific API availability varies, they operate extensive research and manufacturing infrastructure.

• Dr. Reddy's Laboratories (India):
  Known for endocrine pharmaceutical ingredients, Dr. Reddy’s has capabilities for producing estrogenic compounds, including diethylstilbestrol derivatives. Their global compliance standards ensure quality for research and medicinal use.

• Novartis (Switzerland/Global):
  Novartis’ API division produces a broad portfolio of hormonal APIs, adhering to stringent quality measures. Though they focus mostly on well-established APIs, some older or discontinued compounds like DES diphosphate may be available via authorized distributors.

• Sandoz (Novartis division):
  Specializes in generic medications and APIs, with historical production lines for estrogenic compounds.

2. Contract Manufacturing Organizations (CMOs)

CMOs provide custom synthesis and high-volume manufacturing tailored to specific regulatory standards.

• BASF SE (Germany):
  BASF offers a wide portfolio of chemical API synthesis, including research-grade hormonal compounds. They provide custom synthesis services for specialty APIs, including diphosphates, subject to client requirements.

• Lonza (Switzerland):
  With extensive experience in large-scale API manufacturing, Lonza offers hormonal API synthesis with a focus on cGMP compliance. They are capable of producing diethylstilbestrol diphosphate or similar derivatives based on client specifications.

• Piramal Pharma Solutions (India/UK):
  Known for high-quality API production, including hormonal and steroid compounds, with robust quality frameworks suitable for regulated markets.

• Hovione (Portugal):
  Specializes in fine chemicals and intermediates, with capabilities for the synthesis of estrogenic compounds and phosphates via custom processes.

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Research and Specialty API Suppliers

While mainstream pharmaceutical suppliers focus on controlled, high-compliance production, some specialized vendors provide research-grade or academic-quality APIs, often for laboratory use, procurement, or historical research.

• Toronto Research Chemicals (Canada):
  Offers diethylstilbestrol diphosphate or related analogs in research-grade purity, suitable for laboratory experiments but not for clinical applications.

• Sigma-Aldrich (part of Merck Group):
  May have rare or analog compounds, including estrogenic derivatives; however, sourcing specific diphosphate forms could require custom synthesis or direct inquiry.

• Toronto Research Chemicals:
  Provides research-quality diethylstilbestrol derivatives, with custom synthesis options for specialized needs.

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Key Marketplace Platforms and Distributors

• VWR International:
  Supplies chemical reagents and APIs, often through global distribution channels.

• Alfa Aesar (Thermo Fisher Scientific):
  Offers specialty chemicals and APIs, including some hormonal compounds, with a focus on research-grade materials.

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Due Diligence in Source Selection

• Quality Verification:
  Prioritize suppliers with comprehensive analytical testing, batch consistency, and transparent documentation. Certificates of Analysis (CoA), APIs purity levels, residual solvents, and endotoxin testing are critical.

• Regulatory Approvals:
  Suppliers with EDQM, FDA, EMA, or local regulatory approval ensure compliance, especially important for clinical research and investigational use.

• Supply Chain Risks:
  Confirm the supplier's manufacturing capacity, geographic stability, and ability to fulfill large or recurring orders.

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Future Trends and Considerations

Although diethylstilbestrol diphosphate faces regulatory and safety hurdles, ongoing developments in hormonal research and chemical synthesis technologies may influence sourcing dynamics. Suppliers leveraging modern synthetic methodologies, such as green chemistry or continuous manufacturing, are better positioned for consistent and compliant API production in the future.

Furthermore, with increased scrutiny on controlled substances, obtaining this API might involve stringent licensing, import/export licenses, and compliance with international drug precursor regulations, such as the Chemical Control Laws (e.g., CWC) and national legislation.

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Conclusion

Sourcing bulk diethylstilbestrol diphosphate requires navigating a landscape of high-quality, compliant suppliers capable of meeting stringent pharmaceutical standards. Leading pharmaceutical manufacturers like Cipla and Dr. Reddy's, along with specialized CMOs like Lonza and BASF, form the core supply chain. Procurement should incorporate rigorous quality verification, regulatory adherence, and assurance of supply stability. Given the compound's historical and research significance, these suppliers remain key players, but due diligence is critical due to regulatory restrictions and safety concerns.

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Key Takeaways

• Prioritize suppliers with GMP compliance, regulatory approvals, and transparent quality control processes.
• Major pharmaceutical and endocrine API manufacturers include Cipla, Dr. Reddy’s, Lonza, and BASF.
• Custom synthesis via CMOs offers flexibility for specialized bulk API production.
• Research-grade suppliers like Toronto Research Chemicals and Sigma-Aldrich can provide DI diphosphate for laboratory use but are unsuitable for clinical applications.
• Regulatory complexities necessitate thorough due diligence, licensing, and verification when sourcing this compound.

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FAQs

1. Is diethylstilbestrol diphosphate legally available for pharmaceutical manufacturing?
It depends on regional regulations. Due to safety concerns and historical restrictions, its availability is limited, often requiring special licenses and compliance with drug precursor laws.

2. Can I buy diethylstilbestrol diphosphate directly from major API manufacturers?
Most large manufacturers supply only to approved entities with proper licensing. Direct purchasing for research purposes or non-regulatory uses is more feasible through authorized distributors or research chemical suppliers.

3. What regulatory concerns exist with sourcing DES diphosphate?
The compound’s estrogenic activity and history of misapplication subject it to strict control, including licensing requirements, import/export restrictions, and adherence to chemical control laws.

4. Are there safer or alternative compounds?
Yes. Depending on the intended application, safer or alternative estrogenic compounds with similar activity might be recommended.

5. What quality standards should I verify before procurement?
Ensure certificates of analysis, purity levels (>98%), residual solvent testing, endotoxin testing, and compliance with GMP or equivalent standards.

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Sources:

[1] World Health Organization. International Pharmacopoeia.
[2] U.S. Food and Drug Administration (FDA) Annotated Commercial Drug List.
[3] Pharmaceutical Manufacturing Partner Websites and Company Disclosures.
[4] European Directorate for the Quality of Medicines & HealthCare (EDQM).
[5] Chemical Suppliers and Chemical Register Listings.