Bulk Pharmaceutical API Sources for dienestrol

Bulk Pharmaceutical API Sources for dienestrol

Vendor	Vendor Homepage	Vendor Sku	API Url
TCI (Tokyo Chemical Industry)		D0449
Molport		MolPort-003-666-162
Hangzhou APIChem Technology		AC-13162
AKos Consulting & Solutions		AKOS015902490
Finetech Industry Limited		FT-0624756
Finetech Industry Limited		FT-0666712

Bulk Active Pharmaceutical Ingredient (API) Sources for Dienestrol

Last updated: July 29, 2025

Introduction

Dienestrol, a non-steroidal estrogenic compound, has historically been utilized in hormone therapy and research applications. Its structure and mechanism of action categorize it within the class of synthetic estrogens, comparable to diethylstilbestrol but with distinct pharmaceutical attributes. The supply chain for dienestrol's Active Pharmaceutical Ingredient (API) is critical for compounding pharmaceutical formulations, regulatory compliance, and research developments. This article investigates the key bulk API sources for dienestrol, explores market dynamics, evaluates manufacturing potentials, and provides strategic insights for stakeholders.

Understanding Dienestrol and Its Market Context

Dienestrol (chemical name: 1,2-Benzothiazine-3,3'-dione, diethylenthiobarbituric acid ester) is primarily used in hormone replacement therapy, endocrinology research, and as a standard in bioassays involving estrogenic activity. Its synthesis involves complex chemical procedures, often requiring specialized chemical manufacturing capabilities. Given its niche application, supply sources tend to be limited, often concentrated among specific chemical and pharmaceutical manufacturers worldwide.

Global API Manufacturers and Suppliers for Dienestrol

1. Established Pharmaceutical API Manufacturers

Several pharmaceutical-grade API manufacturers produce dienestrol either as a specialized product or as part of their estrogenic compound portfolios. These manufacturers are predominantly located in Asia, Europe, and North America, with manufacturing plants compliant with Good Manufacturing Practices (GMP).

• Sigma-Aldrich (Merck Group): Historically, Sigma-Aldrich supplied research-grade dienestrol, primarily for laboratory applications. Their API offerings often serve academic and research institutions but may extend to small-scale pharmaceutical compounding. However, commercial supply as a bulk API might be limited or subject to de-listing based on regulatory status.

• Toronto Research Chemicals (TRC): Specializes in research chemicals, including various estrogen analogs like dienestrol, usually available in small quantities. They may offer custom synthesis for bulk quantities upon request.

• Laboratories in China: Several Chinese chemical manufacturers, such as Shandong Lanjian Pharmaceutical Co., Yantai Dongcheng Biochemicals, and other regional firms, produce dienestrol for research and pharmaceutical applications. These companies often provide bulk API at competitive prices but require rigorous vetting for quality assurance and regulatory compliance.

• European Manufacturers: Certain European pharmaceutical companies have retained the capability to produce estrogen-related APIs, including dienestrol, often for research reagents or niche pharmaceutical applications.

2. Contract Manufacturing Organizations (CMOs)

CMOs with expertise in synthetic steroids and estrogens can produce dienestrol on a contract basis. These organizations include:

• Capricorn Scientific: Offers custom API synthesis, including estrogenic compounds, with a focus on research-grade materials.
• CordenPharma and Patheon: Known for contract synthesis services, they can scale production of dienestrol for clinical or research purposes, subject to client requirements and regulatory pathways.

3. Emerging Markets and Low-Cost Sources

Several emerging markets, particularly in Southeast Asia, Eastern Europe, and South America, host chemical traders offering dienestrol APIs. These sources may vary significantly in quality, regulatory compliance, and reliability.

• Indian API Manufacturers: Companies such as Sri Sai Synthetics and Gala Biotech manufacture estrogenic APIs, including dienestrol, mainly for research and API trading. Due diligence in quality control and compliance is critical.

• Brazilian and Eastern European Suppliers: These suppliers often cater to local markets but may export APIs globally. Their reliability depends on certification and test reports.

Supply Chain Dynamics and Regulatory Considerations

The compliance landscape significantly influences API sourcing strategies. The primary concerns include:

• Regulatory Approvals: Sourcing from manufacturers with GMP certification and ISO certifications guarantees compliance with international standards.

• Quality Assurance: Certificates of Analysis (CoA), residual solvent profiles, and impurity testing determine suitability for pharmaceutical use.

• Export Restrictions and CITES Compliance: Although dienestrol is not classified as a controlled substance, regulatory restrictions can vary, especially in certain jurisdictions.

• Price and Lead Times: Competitive pricing often correlates with manufacturing location and scale, with Chinese suppliers typically offering lower prices but necessitating thorough quality vetting.

Market Trends and Future Outlook

The demand for dienestrol as a research reagent remains steady, although its pharmaceutical use has diminished due to safer and more effective alternatives. The API market for dienestrol is relatively niche; however, the trend toward custom synthesis and biosimilar development may influence supply dynamics.

Emerging gene-modification technologies and synthetic pathways could reduce reliance on traditional chemical synthesis, potentially impacting API availability and sourcing costs.

Key Factors for Stakeholders

• Due Diligence: Ensure suppliers provide comprehensive documentation, including GMP certification, batch records, and stability data.

• Supplier Diversification: To mitigate supply risks, sourcing from multiple reputable vendors in different regions can enhance supply chain resilience.

• Regulatory Alignment: Always verify local and international regulations concerning API import/export, particularly if intended for clinical use.

• Pricing Strategies: Engage in long-term partnerships with suppliers capable of scaling API production, securing favorable pricing and lead times.

Conclusion

While dienestrol remains a niche API with a primarily research-oriented market, reputable sources are accessible through Chinese chemical producers, European specialty chemical firms, and dedicated contract manufacturers. Ensuring quality and compliance remains paramount due to regulatory intricacies. As the pharmaceutical landscape evolves, so will API sourcing opportunities, making ongoing diligence and strategic supplier engagement essential.

Key Takeaways

• Limited yet Accessible: Dienestrol API is available from Chinese manufacturers, European specialty firms, and contract organizations, though primarily for research use.
• Prioritize Quality & Compliance: Always evaluate GMP certification and quality documentation before procurement.
• Diversify Suppliers: Reduce risk by sourcing from multiple vetted suppliers across regions.
• Monitor Regulatory Changes: Stay updated on import/export regulations, especially in regulated markets.
• Strategic Partnerships: Engage with established CMOs for scalable and reliable API supply.

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FAQs

1. Is dienestrol available commercially as a pharmaceutical API?
Dienestrol is mainly available as a research chemical. Commercial pharmaceutical APIs are limited; most supply caters to research and academic institutions.

2. Which regions are the primary sources for bulk dienestrol API?
China hosts the majority of bulk API manufacturing, with additional sources in Europe and North America, primarily for research-grade products.

3. What quality certifications should I verify before sourcing dienestrol?
GMP certification, ISO compliance, Certificates of Analysis (CoA), and residual solvent testing are critical for ensuring API suitability.

4. Are there regulatory restrictions on importing dienestrol?
Restrictions vary by country. While dienestrol is not commonly controlled, verify local regulations concerning estrogenic compounds and chemical imports.

5. Can dienestrol be synthesized on demand through contract manufacturers?
Yes, specialized CMOs can synthesize dienestrol via custom synthesis services, providing scalable and compliant API batches.

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Sources:

[1] Sigma-Aldrich Product Information, 2023.
[2] Toronto Research Chemicals Catalog, 2023.
[3] Chinese Chemical Manufacturer Profiles, ChemicalWeek, 2022.
[4] Contract Manufacturing Market Reports, 2023.
[5] Regulatory Guidelines on Estrogenic APIs, FDA and EMA publications, 2022.