Fenbendazole Tablets 1000mg

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Intensive Care Custom Pack Sizes ICH Stability

Fenbendazole Tablets 1000mg

Intensive strength fenbendazole formulation for severe parasite burden, institutional tenders, and custom therapeutic programs across 100+ countries.

  • Dedicated high-dose compression lines with validated tooling and in-process controls
  • Complete CTD/ACTD dossier, DMF-ready documents, and tender support documentation
  • Bulk drums, HDPE bottles, or strip packs for institutional supply chains

24-36 months

Shelf Life

Custom 10s – 500s | Bulk drums

Pack Sizes

WHO-GMP / EU-GMP

Compliance

Technical Specifications

Strength Each tablet contains Fenbendazole BP 1000mg
Dosage Form High-dose film-coated tablets
Route of Administration Oral
Indications Severe helminthiasis, schistosomiasis, hepatic/intestinal amoebiasis, institutional antiparasitic programs
HS Code 3004.90.90
Regulatory Support COA, MOA, BMR, Stability, WHO-GMP, EU-GMP, COPP, CTD/ACTD

Therapeutic Applications

Institutional tenders (MoH, military, large hospitals)

NGO emergency stockpiles

National parasite eradication programs

Specialty distributors requiring custom labeling and pack inserts

Packaging & Stability

Primary Packaging High-barrier Alu-Alu / blister strips or HDPE bottles
Bulk Options HDPE drums / jars for institutional dispensing
Storage 15°–30°C (59°–86°F) away from light/moisture
Stability Support Zone III / IVb ICH stability data available

Regulatory Documentation Support

Manufacturing Compliance

WHO-GMP, EU-GMP, ISO certifications for Taj Pharma facility.

Quality Dossier

COA, MOA, BMR, Process Validation, analytical validation, OOS summary.

Regulatory Kit

COPP, CTD/ACTD modules, Stability, FSC, Certificate of Origin.

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Need Full Documentation or Custom Packaging?

Request COPP, COA, stability data, or multilingual packaging layouts tailored to your tender requirements.

For prescription and export purposes only. Use under medical supervision. Not intended for self-medication. Information for educational purposes. Export subject to local regulations.