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Suppliers and packagers for generic pharmaceutical drug: EFLORNITHINE HYDROCHLORIDE
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EFLORNITHINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Uswm | IWILFIN | eflornithine hydrochloride | TABLET;ORAL | 215500 | NDA | USWM, LLC | 78670-150-01 | 1 BOTTLE in 1 CARTON (78670-150-01) / 100 TABLET in 1 BOTTLE | 2024-01-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: EFLORNITHINE HYDROCHLORIDE
Eflornithine Hydrochloride (CAS: 56-23-5) Supplier Landscape
Who supplies eflornithine hydrochloride API and finished-dose products?
Eflornithine hydrochloride is supplied through a mix of API manufacturers and distributors, with finished-dose availability tied to historic brand supply chains. Market access depends on whether you need API (active pharmaceutical ingredient) or drug product (tablets, solution, or infusion-ready formats), and whether your use case is commercial supply, clinical trials, or hospital procurement.
Common supplier types
- API manufacturers: Produce eflornithine hydrochloride drug substance; typically sell via direct contracts or through authorized distributors.
- Global distributors: Source API from one or more manufacturers and handle packaging, documentation, and export/import.
- Finished-dose channels: In markets where the brand is discontinued or limited, procurement routes often shift to parallel distribution, hospital supply, or product re-imports where legally permitted.
Which companies are active in eflornithine hydrochloride supply?
Public supplier lists vary by country, packaging form, and whether the listing is for API vs finished product. The most reliable view comes from global chemical/pharma procurement directories that maintain active catalog pages for eflornithine hydrochloride.
Catalog-listed supplier organizations (API and/or chemical-grade listings)
The following organizations appear in public-facing catalogs or procurement databases as sellers of eflornithine hydrochloride:
- MedChemExpress (MCE) (catalog seller; typically chemical supply channel)
- ChemScene (catalog seller; typically chemical supply channel)
- TargetMol (catalog seller; typically chemical supply channel)
- Cayman Chemical (catalog seller; often reference-standard / research channel)
- TCI Chemicals (catalog seller)
- Thermo Fisher Scientific (catalog seller via branded chemical reagents or reference standards depending on region)
- Selleck Chemicals (catalog seller)
These entries are generally suited to research and smaller-scale procurement rather than routine commercial API sourcing, unless separately confirmed via GMP status documentation.
Pharma-grade / GMP API and distribution
For GMP API, eflornithine hydrochloride supply typically runs through:
- Authorized pharmaceutical distributors that hold regional licenses
- Contract manufacturers and legacy API sources aligned with historical production
- Tender-driven hospital procurement in endemic-NTD geographies
A complete GMP-approved list is contract- and jurisdiction-specific and requires verification of:
- DMF/EDMF status
- GMP certificate scope for the exact intermediate and final API form
- CoA batch traceability to your target specification
What specifications do suppliers typically support?
Supplier catalog listings often show broad chemical-grade specs. For pharmaceutical use, procurement teams must align with internal standards for:
- Assay/potency (usually expressed as anhydrous basis where applicable)
- Impurities (individual impurity limits)
- Residual solvents (ICH Q3C alignment)
- Water content if relevant to the solid form
- Particle size only if your downstream formulation requires it
- Microbiological controls (if finished dosage or sterile process implications apply)
- Salt form confirmation (hydrochloride)
Regulatory and quality documentation that procurement should demand
For commercial or clinical GMP supply, suppliers should provide:
- GMP compliance certificate covering the manufacturing site(s)
- DMF/CEP/EDMF references where applicable
- CoA for each batch, including:
- assay
- impurity profile
- residual solvents
- elemental impurities (if applicable)
- microbiological results (if applicable to grade)
- Manufacturing site statement with change control history
Finished-dose supply: who sells eflornithine products?
Eflornithine hydrochloride is historically known in the brand ecosystem for treatment of African trypanosomiasis (sleeping sickness) and other indications in the past. Finished-dose market availability depends on:
- country-specific marketing authorization status
- tender status
- manufacturing and distribution discontinuations
Procurement for finished product should be sourced through:
- country marketing authorization holders
- authorized wholesalers with chain-of-custody controls
- hospital tender suppliers where the product is stocked under regulated procurement frameworks
How suppliers differ by procurement route
| Procurement route | Typical supplier profile | Best fit |
|---|---|---|
| API chemical catalog | Specialty chemical vendors | R&D, non-clinical, smaller quantities |
| GMP API via pharma distribution | Authorized pharma distributors or legacy GMP API sources | Clinical and commercial supply (subject to verification) |
| Finished-dose procurement | Market authorization holders/authorized wholesalers | Hospital and government channels |
Practical sourcing checklist (to identify the right supplier fast)
- Confirm the need for API vs drug product
- Require GMP grade documentation for pharmaceutical use
- Verify salt form (hydrochloride) and physical form (solid grade, packaging)
- Align with your target specification sheet (assay and impurity system)
- Request CoA for the last 3 batches and confirm method traceability
- Validate documentation lead time for batch release and export paperwork
Key Takeaways
- Eflornithine hydrochloride is widely listed in public chemical catalogs via research-supply vendors, but those listings often do not equate to GMP API supply without formal confirmation.
- Pharmaceutical-grade procurement typically relies on authorized pharma distribution channels and legacy or contract GMP API sources, with sourcing gated by DMF/EDMF and GMP certificate scope.
- For high-stakes R&D or commercial supply, supplier selection must be anchored to GMP documentation, CoA batch history, and impurity/spec alignment for the exact salt form and intended grade.
FAQs
1) Are eflornithine hydrochloride suppliers generally the same for API and finished drug product?
No. API supply often comes from specialty chemical or GMP API sources, while finished-dose availability is tied to market authorization and hospital distribution channels.
2) Can research catalog sellers provide pharmaceutical-grade GMP eflornithine hydrochloride?
Sometimes, but GMP status must be verified via the supplier’s GMP certificate scope and documented quality system for the specific product/grade.
3) What is the most important documentation to request for GMP API sourcing?
A current GMP compliance certificate for the manufacturing site, plus a DMF/EDMF reference (where applicable) and batch CoAs with full impurity and solvent profiles.
4) What country factor most affects eflornithine hydrochloride availability?
Regulatory status and tender-driven procurement in the destination country, especially for finished-dose product.
5) What does “hydrochloride” change for sourcing?
It defines the salt form and impacts specifications such as assay basis, impurity profile expectations, and handling in downstream formulation.
References
[1] MedChemExpress. “Eflornithine hydrochloride” product listing. https://www.medchemexpress.com/
[2] ChemScene. “Eflornithine hydrochloride” product listing. https://www.chemscene.com/
[3] TargetMol. “Eflornithine hydrochloride” product listing. https://www.targetmol.com/
[4] Cayman Chemical. “Eflornithine hydrochloride” product listing. https://www.caymanchem.com/
[5] TCI Chemicals. “Eflornithine hydrochloride” product listing. https://www.tcichemicals.com/
[6] Thermo Fisher Scientific. “Eflornithine hydrochloride” product listing (by region and catalog). https://www.thermofisher.com/
[7] Selleck Chemicals. “Eflornithine hydrochloride” product listing. https://www.selleckchem.com/
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