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Suppliers and packagers for generic pharmaceutical drug: ETHANOLAMINE OLEATE
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ETHANOLAMINE OLEATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| 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 |
Suppliers and packagers for generic pharmaceutical drug: ETHANOLAMINE OLEATE
Ethanolamine Oleate Supplier Landscape: Who Manufactures Pharmaceutical-Grade Ethanolamine Oleate (CAS 104-68-3) and What to Source
Ethanolamine oleate is a fatty-acid salt used as a surfactant/emulsifier and formulation excipient in pharmaceutical and topical products. Supplier coverage for “pharmaceutical-grade” material is fragmented across fine-chemical distributors and specialty surfactant manufacturers; most commercial supply chains list it under fatty-acid salt or “oleate of ethanolamine” catalog naming, with grade controls driven by intended use (pharma excipient vs industrial).
Commercially relevant supplier types
- Specialty oleochemicals and surfactant manufacturers producing ethanolamine oleate from ethanolamine and oleic acid.
- Fine-chemical distributors sourcing from those manufacturers and selling in pharmaceutical or high-purity grades.
- Regional chemical producers for commodity surfactants where “pharma” status depends on documentation (CoA, GMP/DMF availability, impurity specs).
Actionable sourcing priorities
- Confirm whether the product is sold as pharmaceutical excipient (quality documentation aligned to excipient use) or as industrial/technical grade.
- Require documentation packages: CoA, impurity profile, manufacturing site statements, and allergen/TSE/BSE statements where applicable.
- Align with end-formulation needs (solubility, viscosity, pH behavior, saponification value, free fatty acid limits, and batch-to-batch consistency).
What this affects for R&D and regulatory
- If used in an FDA/EMA-regulated formulation, the supplier’s ability to support GMP supply, change control, and regulatory dossiers matters more than catalog price.
Who supplies pharmaceutical-grade ethanolamine oleate and what quality documentation do they provide?
Primary supplier categories that typically cover ethanolamine oleate for pharma use
- Oleochemical/surfactant producers
- Produce ethanolamine oleate as a salt of oleic acid.
- Common documentation includes full specification sheets and batch CoAs.
- Excipient-focused distributors
- Sell ethanolamine oleate under a pharma-aligned spec.
- Documentation often includes excipient-grade COAs, regulatory support statements, and traceability.
- Regional chemical suppliers
- Provide ethanolamine oleate where “pharmaceutical grade” is dependent on contract specs rather than a formal excipient listing.
Quality documentation to expect from credible pharma-facing suppliers
- Certificate of Analysis (CoA) per lot: appearance, assay/content, moisture, pH (if specified), unsaponifiables, free ethanolamine (if relevant), free fatty acids, and key impurities (process-related).
- Specification sheet: limits for fatty-acid profile and impurity targets.
- GMP capability statements for excipient supply (or manufacturing controls if not full GMP).
- Change control: notice of composition, process, or supplier changes.
- Safety and regulatory support: SDS, allergen/TSE/BSE statements where used in pharma supply chains.
What are the top commercial manufacturers and distributors of ethanolamine oleate?
A complete, audit-ready list of “pharmaceutical-grade ethanolamine oleate” suppliers requires cross-checking current catalogs and grade offerings against GMP/excipient documentation. Public listings frequently use varied naming:
- “Ethanolamine oleate”
- “Oleic acid ethanolamine salt”
- “Ethanolamine ester of oleic acid” (naming variation)
- CAS-linked listings sometimes map to different grade tiers
Supplier identification approach used in pharma procurement
- Search by CAS 104-68-3 plus “pharmaceutical” or “excipient” grade.
- Filter by manufacturers that provide formal excipient documentation or GMP supply.
- Validate that the grade is not merely “technical” by checking impurity specs and documentation scope.
Supplier targets for procurement
- Specialty surfactant producers (oleochemical-salt route).
- Excipient distributors with pharma quality management and documentation packages.
(For a procurement-grade supplier roster, you must confirm current availability and grade-specific specs on each supplier’s website/catalog entry or via direct purchase documentation, because grade naming and pharma alignment change frequently.)
How do ethanolamine oleate suppliers qualify pharmaceutical excipient supply?
Qualification criteria that buyers use
- GMP manufacture or controlled excipient production environment.
- Data package readiness:
- CoA format history
- impurity and residuals approach
- analytical method references (where provided)
- Consistency:
- stable fatty-acid profile of the oleate source
- low batch variability in assay and pH behavior
- Regulatory support:
- DMF/CEP references if available (rare for small excipient salts but sometimes offered)
- letter of access or supplier letters when needed
Regulatory-aligned documentation often required
- SDS and shipping documentation
- TSE/BSE statements (if used in sterile or regulated supply chains)
- Allergen statements (process-related, if relevant)
Which suppliers offer ethanolamine oleate with the tightest impurity specs for pharma?
In practice, impurity limits depend on:
- whether oleic acid input is controlled by grade (e.g., purified oleic acid vs lower-grade feedstock),
- whether ethanolamine input is refined,
- and the supplier’s salt formation and purification route.
Procurement indicators of tighter specs
- explicit impurity limits in the spec sheet
- defined free fatty acid limits and unsaponifiables limits
- defined moisture range
- defined residual ethanolamine (or related residuals)
- consistent appearance and viscosity range across lots
Where supplier quality diverges
- Many suppliers sell “ethanolamine oleate” as a surfactant ingredient without pharma-spec impurity control, and the spec is negotiated case-by-case.
What naming differences and CAS mapping issues affect ethanolamine oleate sourcing?
Common sourcing problems include:
- Catalog names that omit “ethanolamine” or “oleate” while still referencing the same chemistry.
- CAS-linked listings that do not guarantee identical grade purity or impurity profiles.
- “Ethanolamine oleate” sold as a mixture or with variable oleic acid profile (depending on oleic acid feed).
Procurement control
- Use CAS 104-68-3 plus grade/spec matching.
- Require a per-lot CoA to ensure assay and impurity targets meet intended use.
Does ethanolamine oleate have supplier constraints for topical vs oral pharma use?
Supplier constraints typically come from:
- end-product route: topical products need different impurity tolerance and microbial control expectations than oral formulations.
- dose form: semisolid systems need stable rheology and consistent emulsification performance.
- regulatory expectations: even when material is excipient-only, submission dossiers often require consistent quality.
Typical buyer pattern
- Choose suppliers offering documentation aligned to excipient use and stable long-term supply.
- Prefer suppliers with consistent batch profiles and the ability to support change-control notifications.
What is the Orange Book status of ethanolamine oleate, and does exclusivity affect suppliers?
Ethanolamine oleate is not a branded prescription drug active ingredient in the Orange Book sense; it is an excipient/surfactant ingredient used within drug products. Exclusivity and Orange Book listings usually relate to drug products (active pharmaceutical ingredients and certain formulations), not excipient chemical commodity salts.
Supplier implication
- No market exclusivity on ethanolamine oleate itself.
- Competition is driven by grade availability, documentation, and regulatory support.
Are there patent-licensing or manufacturing-process IP barriers for ethanolamine oleate?
Ethanolamine oleate is a well-known chemical salt. In most jurisdictions, IP barriers are more likely tied to:
- specific formulations in which ethanolamine oleate is used,
- specific delivery systems,
- or process improvements that are proprietary to a given manufacturer.
Supplier implication
- Supplier availability is usually not constrained by broad composition patents.
- Contracting focus should be on quality, not IP clearance for the base material.
How should pharma buyers build a supplier shortlist for ethanolamine oleate?
A practical shortlist framework:
- Verify excipient-facing documentation (not only technical product pages).
- Request spec sheets with explicit impurity limits.
- Confirm GMP manufacturing statements aligned to intended regulatory use.
- Evaluate sample CoAs for assay, moisture, free fatty acid, and impurity markers.
- Assess supply continuity and change-control responsiveness.
Procurement deliverable
- A signed supplier quality agreement aligned to release testing and batch acceptance criteria.
Key Takeaways
- Ethanolamine oleate sourcing for pharma use hinges on grade documentation and impurity control, not just catalog availability.
- Supplier landscape is split across oleochemical manufacturers and pharma-facing distributors; verify that the offered grade supports excipient use with a per-lot CoA and explicit specifications.
- Orange Book exclusivity is not a direct factor because ethanolamine oleate is typically an excipient/ingredient, not a separately listed drug product.
- Build a shortlist by demanding spec-sheet impurity limits, CoA history, GMP/manufacturing controls, and change-control commitments.
FAQs
1) What CAS number is used to source ethanolamine oleate consistently across suppliers?
CAS 104-68-3 is commonly used; matching by CAS plus spec is required to avoid grade drift.
2) Is ethanolamine oleate typically supplied as a pure chemical or as a variable surfactant mixture?
It is often sold as a defined salt, but supplier grade can vary with feedstock purification and purification process, so spec review and CoA matching are required.
3) Do pharmaceutical buyers require GMP for ethanolamine oleate excipient supply?
Many buyers expect GMP-aligned excipient supply documentation and long-term change control, especially for regulated end products.
4) What quality attributes most affect performance of ethanolamine oleate in formulations?
Assay/content, moisture, free fatty acid/unsaponifiables, residuals, and batch-to-batch pH and emulsification behavior.
5) Are there substitute excipients if a supplier cannot meet impurity specs?
Common substitutes are other fatty-acid ethanolamine salts and related surfactants/emulsifiers, but substitution requires formulation revalidation for performance and regulatory documentation.
References
- PubChem Compound Summary for “Ethanolamine oleate.” (accessed 2026-05-30).
- U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (accessed 2026-05-30).
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