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Suppliers and packagers for generic pharmaceutical drug: TRICLABENDAZOLE
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TRICLABENDAZOLE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novartis | EGATEN | triclabendazole | TABLET;ORAL | 208711 | NDA | Novartis Pharmaceuticals Corporation | 0078-0937-91 | 4 TABLET in 1 BLISTER PACK (0078-0937-91) | 2019-02-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: TRICLABENDAZOLE
What Are the Key Triclabendazole Suppliers by Segment?
Triclabendazole sourcing splits into three practical lanes: (1) branded originators that control clinical/label claims and licensed manufacturing, (2) generic API manufacturers that supply triclabendazole bulk drug substance, and (3) finished-dose formulators that supply tablets/oral suspensions under local registrations. The supplier map below is structured to support procurement, partner screening, and patent-risk diligence.
Which companies supply triclabendazole API (drug substance)?
Triclabendazole API supply is concentrated among chemical manufacturers that produce benzimidazole anthelmintics for the generic market. The most common procurement paths are through Chinese, Indian, and EU-compliant bulk-drug intermediaries that sell triclabendazole as API, often with CEP/DMF support depending on destination.
Typical API supplier categories in practice
| Supplier lane | What they sell | What buyers verify first |
|---|---|---|
| DMF/CEP-backed API manufacturers | Triclabendazole API | CEP/DMF, CoA lot history, impurity profile, residual solvents, polymorph/particle specs (when provided) |
| Contract manufacturers (CMOs) | API or API in-process intermediates | Capability for scale-up, regulatory dossier ownership, batch traceability |
| Trading distributors | API under their commercial label | Traceability to original API site, GMP status, import licenses, re-testing policy |
Commercial reality: Many “supplier” listings online are distributors rather than the API site. For procurement-grade diligence, buyers should screen for the actual manufacturing site referenced on CoA and batch manufacturing record.
Who supplies triclabendazole finished dosage (tablets/suspension) by region?
Finished-dose supply typically comes from generic pharmaceutical companies that file local marketing authorizations and distribute through public and private channels. Regional availability depends on national procurement tenders and form-specific registrations.
Common finished-dose supply model
- Local brand registrants (marketing authorizations)
- Tenders through distributors and wholesalers
- Hospital supply chains for neglected tropical disease programs
Because finished-dose triclabendazole is frequently procured through tenders, the supplier list changes with each tender cycle and country.
What are the procurement-grade supplier checkpoints for triclabendazole?
Triclabendazole procurement needs to align with anthelmintic quality expectations and API-to-finished-dose consistency.
API checkpoints
- GMP compliance at manufacturing site for drug substance
- Batch-level CoA with assay, related substances, water/solvent measures (as applicable)
- Impurity list matching the buyer’s regulatory expectations for benzimidazoles
- Packaging integrity and temperature controls where specified
Finished-dose checkpoints
- Local marketing authorization (MA) status for the target country
- Strength, dissolution, and content-uniformity specs that match local pharmacopeia requirements
- Lot release documentation (CoA, sterility is not relevant; microbiological controls may be)
- Stability data package aligned to storage claims
How should buyers structure a supplier shortlist for triclabendazole?
A workable shortlist for investment-grade diligence typically ranks suppliers by:
1) Regulatory dossier readiness
Preference for suppliers that can support DMF/CEP or national MA submissions in target markets.
2) Manufacturing transparency
CoA that identifies the manufacturing site, not only a commercial distributor.
3) Quality controls aligned to triclabendazole profiles
Verified related substance reporting and consistent assay across lots.
4) Lead time and logistics reliability
Especially for tenders and NTD program schedules.
What data sources are used to validate triclabendazole suppliers?
Supplier validation typically relies on:
- Public regulatory listings (MA databases and inspection records)
- DMF/CEP registries (where available)
- GMP inspection outcomes and site certifications
- Procurement tender records in endemic-country health systems
This is where “supplier lists” found in catalogs often diverge from the real manufacturing site and regulatory posture.
Key Takeaways
- Triclabendazole supply is best mapped by three lanes: API manufacturers, finished-dose formulators, and distributors/agents.
- For procurement, the decisive factor is traceability to the manufacturing site and regulatory dossier support (DMF/CEP or equivalent).
- Finished-dose supplier availability is market- and tender-dependent, so the supplier map must be updated against local MA and procurement records rather than static catalogs.
- A procurement-grade shortlist should be scored on regulatory readiness, batch traceability, impurity/spec alignment, and lead time.
FAQs
1) Is triclabendazole supplied mainly as API or finished dosage?
Both. API is commonly sold for generic formulation; finished-dose supply dominates for public tenders and direct clinical distribution.
2) Why do “supplier” listings often misidentify the manufacturer?
Because many listings are for distributors or trading companies that resell API or finished products without manufacturing.
3) What quality documents matter most when sourcing triclabendazole API?
Site GMP evidence, CoA with assay and related substances, and batch traceability that identifies the manufacturing site.
4) How do I compare API suppliers across regions?
Use dossier support (DMF/CEP or local regulatory acceptance), impurity reporting consistency, and documented stability for finished-dose compatibility.
5) Do finished-dose suppliers stay constant year to year?
Often not; finished-dose availability changes with local marketing authorization status and tender awards.
References (APA)
[1] European Medicines Agency. (n.d.). Public assessment reports and related information for medicinal products. https://www.ema.europa.eu/
[2] U.S. Food and Drug Administration. (n.d.). Drug databases and regulatory information. https://www.fda.gov/drugs
[3] World Health Organization. (n.d.). Treatment and control information for neglected tropical diseases, including anthelmintics. https://www.who.int/
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