Name: Fenbendazole Tablets
Brand: Taj Pharma
Availability: InStock

Validated Data for Regulatory Confidence

Taj Pharma provides complete analytical, manufacturing, and stability documentation to support Fenbendazole registrations across 100+ countries. Each strength (222mg, 444mg, 500mg, 1000mg) is backed by comprehensive technical files compliant with WHO-GMP, EU-GMP, and ICH guidelines.

ICH-compliant stability reports (Zone III / IVb) with trend analysis.
Full analytical method validations covering system suitability, specificity, accuracy, precision, LOD/LOQ.
Process validation, cleaning validation, and equipment qualification reports.

High-Level Specifications

API: Fenbendazole BP / USP compliant
Manufacturing Facility: Vapi, Gujarat – dedicated anthelmintic block
Batch Sizes: 100,000 – 1,000,000 tablets
Release Testing: USP/Ph.Eur/WHO monograph alignment

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Fenbendazole Technical Specifications Laboratory Equipment

Advanced Pharmaceutical Laboratory

State-of-the-art facility equipped with:
• HPLC systems for assay and impurity profiling
• Gas chromatography for residual solvent analysis
• UV-Vis spectrophotometry for dissolution testing
• ICH stability chambers for Zone III/IVb studies
• Microbiology lab for sterility and bioburden testing
• Digital data integrity systems for regulatory compliance

Comprehensive quality control and validation studies supporting Fenbendazole registrations across 100+ countries with WHO-GMP, EU-GMP, and ICH compliance

Product Strength Comparison

Parameter	222mg	444mg	500mg	1000mg
Active Ingredient	Fenbendazole BP 222mg	Fenbendazole BP 444mg	Fenbendazole BP 500mg	Fenbendazole BP 1000mg
Dosage Form	Uncoated / Film-coated	Uncoated / Film-coated	Film-coated	Film-coated
Route of Administration	Oral	Oral	Oral	Oral
Pharmacological Class	Benzimidazole Anthelmintic	Benzimidazole Anthelmintic	Benzimidazole Anthelmintic	Benzimidazole Anthelmintic
Indications	Community deworming, paediatric dosing	Balanced therapy for helminths	Broad-spectrum human parasitic infections	Intensive therapy for severe parasite burden
HS Code	3004.90.90	3004.90.90	3004.90.90	3004.90.90
Available Pack Sizes	10s, 30s, 100s, 500s	10s, 30s, 100s, 500s	10x10 Alu-Alu, custom bulk	Custom 10s–500s, HDPE drums
Shelf Life (ICH)	24–36 months	24–36 months	24–36 months	24–36 months

Quality & Stability Parameters

Parameter	Specification
Appearance	White to off-white tablets, smooth edges, debossed as per customer artwork
Identification	FTIR / UV match with working standard
Assay	95% – 105% of label claim
Related Substances	Total impurities ≤ 1.5% (individual ≤ 0.5%)
Dissolution	Q = 80% in 45 minutes in phosphate buffer pH 6.8
Uniformity of Dosage Forms	Complies with Ph. Eur./USP criteria
Residual Solvents	Below ICH Q3C limits
Stability Zones	Zone II, III, IVa, IVb data; accelerated 40°C/75% RH, long-term 30°C/65% RH

Documentation Matrix

All Fenbendazole dossiers are structured for CTD / ACTD submission, ensuring faster evaluation by regulatory authorities.

Manufacturing Compliance

WHO-GMP Certificate
EU-GMP Certificate
ISO 9001:2015
cGMP SOP Compendium

Quality Dossier

Certificate of Analysis (COA)
Method of Analysis (MOA) + validation
Batch Manufacturing Record (BMR)
Process validation + cleaning validation
Stability studies (Zone III / IVb)
OOS/OOT summary report

Regulatory Submission

Certificate of Pharmaceutical Product (COPP)
CTD / ACTD modules (Modules 1-5)
Free Sale Certificate (FSC)
Certificate of Origin (CoO)
Packaging artwork + PIL (multilingual)
Pharmacovigilance & risk management plan

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Testing & Validation Infrastructure

Taj Pharma’s QA/QC labs are outfitted with modern instrumentation and digital data integrity systems.

Analytical Lab

HPLC, GC, UV, FTIR, dissolution, particle size analysis, moisture content testing.

Stability Chambers

ICH Zone II/III/IV walk-in chambers with real-time & accelerated monitoring.

Microbiology

Bioburden, sterility (where applicable), and environmental monitoring.

Process Validation

Compression, coating, granulation, and packaging validation with detailed reports.

Fenbendazole Technical Specifications