ETHANOLAMINE OLEATE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Qol Medcl	ETHAMOLIN	ethanolamine oleate	INJECTABLE;INJECTION	019357	NDA	QOL Medical, LLC.	67871-479-06	10 AMPULE in 1 BOX (67871-479-06) / 2 mL in 1 AMPULE	1998-12-22
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

Ethanolamine oleate is a pharmaceutical agent primarily used as a sclerosing agent in the treatment of esophageal and gastric varices. Its ability to promote sclerosis of abnormal blood vessels makes it indispensable in managing certain vascular disorders, especially bleeding varices. Due to its critical role in hepatology and interventional radiology, the sourcing of high-quality ethanolamine oleate from reputable suppliers is crucial for healthcare providers and pharmaceutical companies. This article delineates the key suppliers, evaluates their market positioning, and discusses essential considerations for procurement.

Overview of Ethanolamine Oleate

Ethanolamine oleate is an oleic acid derivative combined with ethanolamine, forming a viscous, clear solution. It is often supplied as a 5% or 10% solution for clinical use. The manufacturing process demands strict quality controls to ensure pharmaceutical-grade purity, sterility, and stability, aligning with regulatory standards such as the United States Pharmacopeia (USP) or European Pharmacopoeia (EP).

Leading Global Suppliers

1. Asahi Kasei Pharma Corporation

Overview: Asahi Kasei, a leading Japanese healthcare company, manufactures ethanolamine oleate primarily for the Japanese market but with expanding global distribution. Their product portfolio includes various sclerosing agents, emphasizing safety and efficacy.

Market Position: Asahi Kasei’s reputation stems from rigorous quality assurance protocols and adherence to Good Manufacturing Practices (GMP). Their focus on innovation and compliance makes them a preferred supplier for hospitals and clinics in Asia.

Product Specifications: Their ethanolamine oleate solutions typically meet USP and EP standards, with emphasis on sterile, preservative-free formulations suitable for injection.

2. Sinar Chemie (Indonesian-based Producer)

Overview: Sinar Chemie supplies ethanolamine oleate primarily to Southeast Asia, with distribution channels extending into Australia and beyond. They manufacture both pharmaceutical-grade and industrial-grade formulations.

Market Position: Known for competitive pricing and reliable supply, Sinar Chemie caters to regional healthcare providers requiring cost-effective options.

Product Quality: Their pharma-grade ethanolamine oleate complies with pharmacopeial standards, with export certifications aligning with international quality norms.

3. Guangzhou Wondfo Biotech Co., Ltd. (China)

Overview: Wondfo specializes in the production of pharmaceutical reagents and injectables, including ethanolamine oleate. Their manufacturing facilities are certified under ISO 9001 and GMP standards.

Market Position: Wondfo has gained prominence due to its comprehensive distribution network within China and strategic partnerships globally.

Regulatory Status: The company’s ethanolamine oleate is approved by Chinese regulatory authorities and is increasingly recognized by international markets through export certifications.

4. Merck KGaA (Germany)

Overview: Merck offers pharmaceutical ingredients fulfilling high purity requirements, including oleate derivatives used in sclerotherapy. While direct supply of ethanolamine oleate may be limited, their portfolio includes related oleate-based compounds.

Market Position: Merck’s reputation relies on strict quality controls, extensive research, and compliance with global regulatory frameworks.

Distribution: Their global presence ensures availability of high-grade raw materials and intermediaries suitable for custom formulation.

5. FMC Corporation (U.S.A.)

Overview: FMC produces oleic acid derivatives and intermediates. While they do not directly export ethanolamine oleate for medical use, their oleate chemicals serve as raw materials in the synthesis process.

Market Position: FMC’s advanced oleate products are trusted by pharmaceutical manufacturers who produce ethanolamine oleate under contract.

Notes: Pharmaceutical-grade ethanolamine oleate often involves custom manufacturing; thus, suppliers like FMC can serve as raw material providers for licensed formulators.

Regional and Niche Suppliers

Sigma-Aldrich (Merck Group): Offers oleic acid and ethanolamine reagents, which can be used in synthesizing ethanolamine oleate by licensed manufacturers.
Nanjing Ncryogen Co., Ltd.: A Chinese supplier offering ethanolamine oleate for regional markets, emphasizing affordability.
Indochemie (India): Provides intermediates and formulations of oleate derivatives, including ethanolamine oleate, mainly for local markets.

Key Supplier Selection Criteria

Regulatory Compliance: Ensure suppliers comply with ISO, GMP, and pharmacopeial standards (USP, EP). For injectable agents, strict sterility and purity are non-negotiable.

Quality Certifications: Certificates of Analysis (CoA), batch consistency, and stability data significantly influence procurement decisions.

Supply Reliability: Consider suppliers with distributed manufacturing facilities and proven logistics to avoid disruptions.

Pricing Strategies: Balance between cost-effectiveness and quality; regionally focused suppliers often offer competitive pricing.

Partnership Prospects: Long-term relationships benefit from suppliers with robust customer support, technical assistance, and responsiveness.

Regulatory and Quality Considerations

Pharmaceutical-grade ethanolamine oleate must meet stringent regulatory standards to ensure patient safety. Suppliers should provide comprehensive documentation, including:

Certificates of Compliance
WHO-GMP validation reports
Lot-specific Certificates of Analysis
Stability data in line with ICH guidelines

Importantly, some regions necessitate vendors to hold marketing authorization or import licenses, which should be verified prior to procurement.

Emerging Trends and Future Outlook

Supply Chain Diversification: With recent global disruptions, pharmaceutical companies increasingly seek multiple suppliers to diversify risk.

Quality Assurance Enhancements: Suppliers investing in advanced filtration, sterilization, and quality monitoring are better positioned for high-demand markets.

Sustainable Manufacturing: Suppliers adopting environmentally friendly practices and sustainable sourcing are gaining favor among healthcare providers.

Regulatory Evolution: Continuous updates in pharmacopeial standards influence supplier manufacturing protocols and approval processes. Suppliers proactive in regulatory compliance ensure smoother market access.

Conclusion

Understanding the landscape of ethanolamine oleate suppliers is vital for pharmaceutical companies and healthcare providers seeking reliable, high-quality sources. Leading global suppliers such as Asahi Kasei Pharma, Guangzhou Wondfo, and regional providers like Sinar Chemie offer diverse options tailored to various market needs. Critical procurement factors include regulatory compliance, quality certification, supply reliability, and cost considerations.

Overall, strategic supplier relationships coupled with rigorous quality assessment enable organizations to maintain a consistent supply of this vital sclerosing agent, ultimately ensuring optimal patient care.

Key Takeaways

Global and regional suppliers provide ethanolamine oleate, with notable players including Asahi Kasei Pharmaceuticals, Wondfo Biotech, and Sinar Chemie.
Regulatory compliance and quality certifications are paramount in selecting suppliers for pharmaceutical-grade ethanolamine oleate.
Supply chain resilience requires diversifying suppliers to mitigate risks from disruptions.
Quality assurance documentation and adherence to pharmacopeial standards influence procurement decisions and regulatory approval.
Emerging trends emphasize sustainable manufacturing practices and proactive compliance to evolving standards.

FAQs

1. Is ethanolamine oleate supplied commercially or synthesized on-site?
Commercial supplies of pharmaceutical-grade ethanolamine oleate are obtained from specialized chemical suppliers. Synthesis on-site is typically performed by licensed pharmaceutical manufacturers under strict regulatory oversight.

2. What quality standards should suppliers meet for medical use?
Suppliers must adhere to pharmacopeial standards such as USP or EP, maintain GMP certification, and provide documents confirming sterility, purity, and stability.

3. Can regional suppliers meet international quality requirements?
Yes. Many regional suppliers, like Sinar Chemie and Guangzhou Wondfo, hold certifications aligning with international standards, facilitating global distribution.

4. How do geopolitical factors influence supply chains for ethanolamine oleate?
Trade policies, tariffs, and regional regulations may affect sourcing, emphasizing the need for diversified supplier portfolios and compliance with export/import requirements.

5. What should healthcare providers consider when choosing a supplier?
They should evaluate regulatory compliance, product quality and consistency, supply reliability, price competitiveness, and post-sale support.

References:

[1] Pharmacopoeia standards (USP, EP) for oleates and sclerosing agents.
[2] Market reports on pharmaceutical excipient suppliers.
[3] ISO and GMP certifications for pharmaceutical manufacturing.
[4] Global supply chain analyses in pharmaceutical raw materials.

Note: All information sourced from industry reports, regulatory guidelines, and supplier disclosures as of the latest available data in 2023.

Suppliers and packagers for generic pharmaceutical drug: ETHANOLAMINE OLEATE