Fenbendazole Tablets 444mg

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Balanced Therapy EU-GMP Data Pack Ready

Fenbendazole Tablets 444mg

Balanced strength fenbendazole tablets delivering broad-spectrum efficacy with high-volume manufacturing capability for government tenders and institutional supply.

  • Validated dissolution, assay, purity, and impurity profiling for regulatory filing
  • Batch sizes scalable up to 1 million tablets with automated compression lines
  • Custom pack inserts and multilingual cartons to match tender specifications

24-36 months

Shelf Life

10s | 30s | 100s | 500s

Pack Sizes

WHO-GMP / EU-GMP

Compliance

Technical Specifications

Strength Each tablet contains Fenbendazole BP 444mg
Dosage Form Uncoated / film-coated tablets
Route of Administration Oral
Indications Filariasis, schistosomiasis, gastrointestinal helminths, amoebiasis
Pharmacological Class Anthelmintic / Benzimidazole
HS Code 3004.90.90
Documentation Available WHO-GMP, COPP, COA, MOA, BMR, Stability, CTD/ACTD

Therapeutic Applications

MoH tenders across Africa & Asia

NGO supply chains

Institutional therapy programs

Distributor / hospital demand planning

Packaging & Stability

Primary Packaging Moisture-protected Alu-Alu or blister
Secondary Packaging Cartons / shipper boxes with tamper-evident seals
Storage Conditions 15°–30Β°C (59°–86Β°F), protect from light and humidity
Stability Support Zone III / IVb stability reports as per ICH guidance

Regulatory Documentation Support

Manufacturing Compliance

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

Quality Dossier

COA, MOA, BMR, process validation, OOS/OOT summary.

Regulatory Kits

COPP, CTD/ACTD modules, Stability (Zone III/IVb), Free Sale Certificates.

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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.