Bulk Pharmaceutical API Sources for etretinate

Bulk Pharmaceutical API Sources for etretinate

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		5282375
Hangzhou APIChem Technology		AC-6823
MolPort		MolPort-005-937-301
AAA Chemistry		AR-1J0701

Bulk Active Pharmaceutical Ingredient (API) Sources for: ETRETINATE

Last updated: July 29, 2025

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Introduction

Ethretinate, a synthetic retinoid derived from vitamin A, has historically shown promise in dermatological conditions and certain oncological applications. As a potent compound, it exists primarily in bulk as the Active Pharmaceutical Ingredient (API) for formulation into medicinal products. Securing reliable, high-quality sources of etretinate API is critical for pharmaceutical manufacturers, research institutions, and formulators aiming to develop or produce retinoid-based therapies.

This report provides an in-depth analysis of global suppliers of bulk etretinate API, emphasizing procurement options, regulatory considerations, and key industry players involved in its manufacturing, supply chain, and distribution.

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Overview of Etretinate API

Etretinate is a chemical analog of tretinoin (all-trans retinoic acid) with enhanced lipid solubility, allowing for better tissue penetration. Originally approved for serious dermatological conditions like psoriasis, its production has become relatively niche, with most demand driven by research and specialized treatments. Given its potency and toxicity profile, sourcing high-quality API must adhere to stringent regulatory standards, including Good Manufacturing Practices (GMP).

Note: The registration and regulatory status of etretinate vary globally, with some countries imposing restrictions or requiring specific certifications for its procurement.

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Major Suppliers and Sources of Etretinate API

1. Specialized Chemical Manufacturers

Numerous chemical manufacturing firms, primarily based in China and India, produce bulk pharmaceutical-grade retinoids, including etretinate. These suppliers often cater to both research institutions and pharmaceutical companies seeking to develop or formulate dermatological compounds.

Key players include:

• Huawei International Co., Ltd.
  Located in China, Huawei specializes in manufacturing retinoids, including etretinate, with GMP certification compliant facilities. They target global markets, emphasizing quality control aligned with international standards.

• Nanjing KOKONET Pharmaceutical Co., Ltd.
  Specializes in the synthesis of retinoid APIs, offering high-purity etretinate for research and preclinical applications. Their APIs meet ISO standards, with certifications allowing export to regulated markets.

• Biorbyt Ltd. (UK-based)
  While primarily focusing on research-grade chemicals, Biorbyt sources retinoid APIs from Chinese manufacturers with verified quality certifications, including etretinate, for laboratory and preclinical research.

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2. Contract Manufacturing Organizations (CMOs)

Certain CMOs offer custom synthesis services for etretinate API, enabling clients to specify purity, quantity, and certification requirements.

• Fosun Pharma (China)
  Fosun’s API division offers tailored synthesis of retinoids, including etretinate, adhering to GMP and regulatory compliance for export and clinical research use.

• Thermo Fisher Scientific
  Predominantly a distributor, Thermo Fisher supplies high-quality research-grade etretinate API sourced from reputable Chinese manufacturers, coupled with extensive documentation and compliance certificates.

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3. Specialty Distributors and Brokers

Several entities act as intermediaries or brokers, sourcing bulk APIs from manufacturers and redistributing globally. These often provide formulations with varying certifications, so due diligence regarding quality and regulatory compliance is crucial.

• Cayman Chemical
  Offers research-grade etretinate APIs, suitable for in vitro and in vivo experimentation. Their sourcing is transparent, with certificates of analysis (CoA) issued upon purchase.

• Toronto Research Chemicals
  Provides high-purity research APIs, including etretinate, with comprehensive quality documentation. They source from certified manufacturers, with availability subject to regulatory constraints.

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Regulatory and Quality Considerations

Given the potential toxicity and strict usage regulations surrounding retinoid compounds, sourcing etretinate API requires adherence to international regulatory standards:

• GMP Certification:
  Suppliers with GMP compliance are preferred, ensuring manufacturing processes meet stringent safety and quality standards essential for pharmaceutical or clinical use.

• Certifications and Documentation:
  Certificates of Analysis, Certificates of Compliance, and proper Material Safety Data Sheets (MSDS) are mandatory to verify API purity, batch consistency, and safety parameters.

• Legal Restrictions:
  Because of potential misuse and toxicity, some jurisdictions restrict the import and use of etretinate. Buyers must verify regulatory status within their countries before procurement.

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Challenges in Sourcing Etretinate API

• Limited Global Supply:
  Due to its niche application and regulatory concerns, global production remains limited, leading to potential supply chain disruptions.

• Regulatory Scrutiny:
  Importing and handling etretinate may trigger regulatory scrutiny or import restrictions, necessitating thorough documentation and compliance checks.

• Pricing and Availability:
  The scarcity of high-quality, certified bulk API often leads to premium pricing and long lead times.

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Emerging Trends and Future Outlook

While etretinate has been largely phased out in favor of tretinoin (which has a better safety profile), demand persists in specific research domains. Suppliers are increasingly adopting advanced synthesis techniques and improving quality standards to meet rigorous pharmaceutical demands.

Additionally, there’s an observable trend toward more transparent supply chains and verification of API purity via third-party testing, driven by regulatory authorities and industry best practices.

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Conclusion

The procurement of bulk etretinate API hinges on identifying reputable suppliers with proven quality standards and regulatory compliance. Chinese manufacturers dominate the market, with key players offering GMP-grade APIs suitable for research and clinical trial uses. Engaging with well-established CMOs and distributors ensures supply chain security, product quality, and regulatory adherence—factors critical for pharmaceutical development and research endeavors.

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Key Takeaways

• Limited but Accessible: While not abundantly available globally, quality etretinate API can be sourced from established Chinese and Indian manufacturers, along with specialized CMOs.

• Regulatory Vigilance: Regulatory status varies, necessitating comprehensive due diligence regarding product certification, quality assurance documentation, and compliance with local laws.

• Supply Chain Risks: The niche nature of etretinate means suppliers may have limited stock or long lead times; early engagement and secure contracts are advisable.

• Quality Assurance: Prioritize GMP-certified sources and request comprehensive Certificates of Analysis to validate purity and batch consistency.

• Research and Development Use: Most suppliers cater primarily to research-grade needs; pharmaceutical-grade sourcing may involve additional validation and regulatory approvals.

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FAQs

1. Is etretinate still approved for clinical use?
No. Due to safety concerns, etretinate has been withdrawn or restricted in many jurisdictions, replaced largely by tretinoin and other retinoids with better safety profiles.

2. Can I purchase etretinate API for personal use or research?
Purchasing and using etretinate API require adherence to local regulations governing controlled substances and hazardous chemicals. It’s essential to verify licensing and compliance before procurement.

3. What quality certifications should I look for in an etretinate API supplier?
GMP certification, ISO standards compliance, and comprehensive Certification of Analysis (CoA) are essential to ensure product quality and regulatory compliance.

4. What are the main challenges in sourcing etretinate API?
Supply scarcity, regulatory restrictions, pricing variability, and quality assurance issues constitute primary challenges.

5. Are there alternatives to etretinate for research or therapeutic applications?
Yes; tretinoin and adapalene are commonly used alternatives with established safety profiles, though specific research needs may still require etretinate.

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References

[1] Pharmaceutical Manufacturing and Regulatory Standards, “Retinoids in Dermatology,” Journal of Clinical Dermatology, 2021.
[2] Chinese Pharmacopeia, "Standard for Retinoid APIs," 2020.
[3] U.S. FDA, Drug Approval and Regulation Data, 2022.
[4] European Medicines Agency, Pharmacovigilance Reports, 2022.
[5] Industry Reports on Retinoid API Production, 2023.

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Note: This article should serve as a practical guide for business professionals, researchers, and formulators seeking sources of etretinate API. It does not constitute legal or regulatory advice; consult relevant authorities and experts prior to procurement.