Fenbendazole Tablets 500mg

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Most Prevailing COPP Ready 100+ Countries

Fenbendazole Tablets 500mg

High-demand broad-spectrum anthelmintic with proven stability, multilingual packaging, and complete regulatory dossiers for rapid registration.

  • Dedicated anthelmintic block with automated compression and coating lines
  • ICH Zone III/IVb stability data and full CTD / ACTD submission packages
  • Customizable packaging for tenders, NGOs, institutional supply, and PCD partners

24-36 months

Shelf Life

10x10 Alu-Alu | Custom | Bulk

Pack Sizes

WHO-GMP / EU-GMP / ISO

Compliance

Technical Specifications

Strength Each tablet contains Fenbendazole BP 500mg
Dosage Form Film-coated tablets
Route of Administration Oral
Therapeutic Class Benzimidazole Anthelmintic
Indications Diarrhea caused by parasites, filariasis, schistosoma infections, liver abscesses, intestinal/hepatic amoebiasis, periodontitis
HS Code 3004.90.90
Documentation Package COA, MOA, BMR, Stability, GMP, COPP, CTD/ACTD dossier

Therapeutic Applications

Government tenders across Africa, Asia, Latin America

Institutional treatment programs and hospitals

PCD franchise marketing kits

Distributors requiring multilingual packs and rapid dossier support

Packaging & Stability

Primary Packaging Alu-Alu / Blister with moisture barrier
Secondary Packaging 10x10 cartons, shipper cartons up to 500s
Storage & Shelf Life 24–36 months at 15°–30Β°C; protect from light/moisture
Custom Packaging Multilingual labels, tamper-evident seals, QR-coded traceability on request

Regulatory Documentation Support

Manufacturing Compliance

WHO-GMP, EU-GMP, ISO 9001:2015 certifications for Taj Pharma’s facility.

Quality Dossier

COA, MOA, BMR, Process Validation, OOS/OOT summary, analytical method validation.

Regulatory Submission

COPP, CTD/ACTD modules, Stability Zone III/IVb, 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.