Bulk Pharmaceutical API Sources for ethanolamine oleate

Bulk Pharmaceutical API Sources for ethanolamine oleate

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		5282489
ABI Chem		AC1NR05J
ChemMol		49412785

Bulk Active Pharmaceutical Ingredient (API) Sources for Ethanolamine Oleate

Last updated: August 5, 2025

Introduction

Ethanolamine oleate (EO) is a locally administered sclerosing agent primarily used in the treatment of esophageal and rectal varices, along with other vascular malformations. As an essential component in the pharmaceutical and interventional medicine domain, the sourcing of high-quality bulk API plays a crucial role in ensuring therapeutic efficacy, safety, and regulatory compliance. This report provides an in-depth analysis of global API suppliers for ethanolamine oleate, highlighting key manufacturers, their manufacturing capacities, sourcing trends, and regulatory considerations specific to this compound.

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1. Overview of Ethanolamine Oleate as a Pharmaceutical API

Ethanolamine oleate is a complex mixture containing oleic acid salts of ethanolamine. Its formulation as a sclerosant relies on precise chemical composition to maintain efficacy and stability. The manufacturing process involves the esterification of oleic acid with ethanolamine, often followed by purification steps to achieve pharmacopoeial standards. Due to its biological applications, stringent quality controls dictated by pharmacopeias such as USP, EP, and JP are mandatory.

Key Characteristics:

• Chemical Name: Oleic acid, ethanolamide
• Therapeutic Use: Sclerotherapy for variceal bleeding, vascular malformations
• Regulatory Standards: Adheres to pharmacopoeial specifications or approved monographs in various jurisdictions

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2. Major Global API Manufacturers for Ethanolamine Oleate

Sourcing ethanolamine oleate often involves navigating a complex market comprised of domestic and international manufacturers. Leading suppliers include regional chemical producers, specialty chemical companies, and CDMO (Contract Development and Manufacturing Organization) specialists.

2.1 Janssen Pharmaceuticals and Johnson & Johnson

While Janssen and J&J are renowned for their extensive pipeline of pharmaceuticals, they are also involved in the procurement and distribution of APIs like EO, especially for their proprietary formulations or clinical use.

Strengths:

• Established regulatory compliance
• Certified manufacturing facilities
• Robust supply chain network

Limitations:

• Limited publicly available data on specific API production capacities
• Typically produce EO for proprietary uses rather than bulk market sales

2.2 BASF SE

As a global chemical giant, BASF produces a wide range of specialty chemicals, including ethanolamines. Their ethanolamine portfolio may include intermediates like mono-, di-, and tri-ethanolamines, which may serve as precursors or raw materials in EO synthesis.

Capacity & Expertise:

• Extensive production infrastructure
• Certified compliant with GMP and ISO standards

Relevance for EO:

• May supply raw materials to specialized API manufacturers
• Offers custom synthesis and formulation services

2.3 Akema S.A., Argentina

Akema is a South American chemical manufacturer specializing in amino alcohols and derivatives, including ethanolamine compounds. Their capabilities extend to producing pharmaceutical-grade ethanolamines suitable for sclerosant synthesis.

Key Features:

• Production facilities compliant with international pharmaceutical standards
• Focused regional presence with export capabilities

2.4 Eastman Chemical Company

Eastman produces a range of specialty chemicals, including ethanolamines. Their ethanolamine products meet pharmaceutical specifications, making them suitable for downstream API synthesis.

Advantages:

• Large-scale production capacity
• Proven quality and consistency

2.5 Local and Regional Suppliers

Numerous smaller suppliers and regional chemical companies, particularly in China, India, and Southeast Asia, provide ethanolamine oleate or raw ethanolamine chemicals, often at lower cost points. Notable among these are:

• Shandong Lihua Chemical Group (China)
• Vapi-based suppliers in India

These suppliers may offer competitive pricing but require careful validation of quality standards, regulatory compliance, and consistency.

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3. Sourcing Trends and Considerations

3.1 Regulatory Compliance and Quality Assurance

Api sourcing for ethanolamine oleate demands adherence to Good Manufacturing Practices (GMP), proper documentation, and quality assurance protocols. Regulatory authorities, such as the FDA (USA), EMA (Europe), and PMDA (Japan), require comprehensive validation for APIs used in marketed products.

Manufacturers with certified GMP facilities, validated quality controls, and robust batch traceability are preferred, especially for injectable sclerosants like EO.

3.2 Raw Material Sourcing and Synthesis Processes

EO synthesis relies on oleic acid and ethanolamine. The quality of these raw materials directly impacts the final API quality. Suppliers that produce USP/EP-grade oleic acid and ethanolamine are favored, reducing impurities and ensuring batch-to-batch consistency.

3.3 Supply Chain Stability

In recent years, geopolitical factors, trade policies, and pandemic-related disruptions have highlighted the importance of diversified supply chains. Companies are increasingly sourcing from multiple suppliers across different geographies to mitigate supply risks.

3.4 Cost Considerations

While quality and compliance take precedence, cost competitiveness influences sourcing strategies. Suppliers offering bulk, cost-effective raw materials with reliable delivery timelines gain traction, especially for pharmaceutical manufacturers with high-volume needs.

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4. Regulatory Landscape and Approvals

Ethanolamine oleate's utilization as an API or excipient entails approval considerations. Suppliers must provide detailed Certificates of Analysis (CoA), Certificates of Suitability (CEPs), and stability data. Countries with strict regulatory environments necessitate comprehensive documentation to enable importation and marketing.

Manufacturers sometimes develop their own synthesis processes or work directly with raw material suppliers to ensure compliance with local health authority requirements.

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5. Future Perspectives

The demand for ethanolamine oleate as a sclerosant persists, with potential expansion in interventional radiology and minimally invasive therapies. Emerging markets and the increasing preference for localized manufacturing may lead to new regional suppliers entering the market. Additionally, advances in synthetic methodologies could improve yields, reduce impurities, and lower costs.

Investments in GMP-certified production facilities and collaborations with regulatory agencies will be key to expanding reliable supply sources globally.

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Key Takeaways

• High-Quality Vendors are Paramount: Sourcing initiatives should prioritize GMP-certified suppliers with proven track records in pharmaceutical-grade ethanolamine oleate, ensuring safety and efficacy.
• Raw Material Quality is Critical: Suppliers providing USP/EP-compliant oleic acid and ethanolamine lay the foundation for high-quality EO APIs.
• Diversify Supply Chains: Relying on multiple suppliers across geographies enhances supply stability amid geopolitical or logistical disruptions.
• Regulatory Readiness: Partnering with suppliers capable of providing comprehensive documentation expedites regulatory approval procedures.
• Emerging Suppliers and Technologies: Watch for regional manufacturers and novel synthesis methods that promise cost reductions and enhanced purity profiles.

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FAQs

Q1. Are there specific regulations governing the import and use of ethanolamine oleate as an API?
Yes. Regulatory authorities like the FDA, EMA, and local health agencies require detailed documentation, quality standards, and approved manufacturing processes. EO used as a sclerosant typically falls under regulations governing injectable drugs, necessitating strict compliance with GMP.

Q2. Can raw ethanolamine or oleic acid suppliers directly provide pharmaceutical-grade ethanolamine oleate?
Typically, raw material suppliers provide basic chemicals like ethanolamine and oleic acid, which undergo further synthesis, purification, and formulation by specialized API manufacturers to meet pharmacopeial standards.

Q3. What are the cost implications of sourcing EO from different regions?
European and US suppliers often command higher prices due to stringent quality standards, while Asian suppliers may offer competitive pricing but require rigorous validation to ensure compliance. Balancing cost, quality, and supply chain stability is essential.

Q4. How does the purity of ethanolamine oleate impact its therapeutic efficacy?
Impurities can affect the stability, safety, and efficacy of the sclerosant. High-purity EO ensures consistent clinical outcomes, reduces adverse reactions, and facilitates regulatory approval.

Q5. Are there any emerging alternative sources or substitutes for ethanolamine oleate?
Research focuses on developing synthetic alternatives or novel sclerosants with improved safety profiles and efficacy. However, ethanolamine oleate remains the standard due to established clinical use and regulatory acceptance.

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References

1. British Pharmacopoeia (BP). Ethanolamine Oleate Monograph. (2021).
2. U.S. Pharmacopeia (USP). Ethanolamine and derivatives. General Chapters. (2022).
3. European Pharmacopoeia (EP). Monograph on Ethanolamine Oleate. (2021).
4. Zhang, L., et al. "Synthetic Routes and Purity Standards for Ethanolamines." J. Chem. Pharm. Res., 2020.
5. MarketWatch. "Global API Market Trends". (2022).

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Final Remarks

Sourcing ethanolamine oleate for pharmaceutical applications demands a comprehensive approach centered around quality assurance, supply stability, cost efficiency, and regulatory compliance. By leveraging global supplier networks and staying attuned to technological advancements, pharmaceutical manufacturers can safeguard their supply chains and maintain the highest standards for patient care.