Fluconazole Tablets

Antifungal · Tablets / Capsules · 150mg / 200mg

Trade Information

Minimum Order Qty	1,000,000 tablets
Capacity	100 Million Tablets per month
Strength	150mg / 200mg
Private Labelling	Custom branding, artwork & market-specific labelling
Lead Time	45–60 days from order confirmation
Payment Terms	LC at sight, TT (advance / against documents)
Shipping	FOB / CIF to major international ports including Mombasa, Dar es Salaam, Lagos, Durban, Manila, Phnom Penh
Pharmacopoeia	BP, USP, IP compliant

Packing Options

Blister (Alu-Alu / Alu-PVC)
Strip pack
Bottle pack (HDPE)
Hospital bulk pack
Custom packing as per buyer requirement

Regulatory & Quality

Registration Status	Registered in multiple African, Asian, and CIS markets. Dossier available for new market registration.
Regulatory Dossiers	CTD / ACTD format dossiers available for submission to national drug authorities.
Stability Data	Zone IVa & IVb stability data available (tropical climate conditions, 30°C/65% RH & 30°C/75% RH)
WHO Prequalification	WHO-GMP Certified

Product Details

Composition	Fluconazole
Dosage Form	Tablets / Capsules
Pack Size	1x1, 1x4, 10x10 / Custom packing available
Storage	Store below 30°C in a dry place, protected from light and moisture
Shelf Life	24 months from date of manufacture

Description

Fluconazole is a triazole antifungal widely used for candidiasis and other fungal infections, including fungal infections associated with immunosuppression. It is listed on the WHO Model List of Essential Medicines.

BioGalen manufactures Fluconazole in 150mg and 200mg tablets and capsules. In regions with high HIV prevalence it has an important role in managing opportunistic fungal infections, supporting steady demand through both retail and programme channels.

Mechanism of Action

Fluconazole is a triazole antifungal that inhibits the fungal enzyme lanosterol 14-alpha-demethylase, a cytochrome P450 enzyme essential for synthesising ergosterol, the principal sterol of the fungal cell membrane. Depleting ergosterol disrupts membrane structure and function and halts fungal growth. Fluconazole has high oral bioavailability and good penetration into body fluids including cerebrospinal fluid, which underpins its use in systemic and central nervous system fungal infections.

Indications

Vaginal candidiasis (including single-dose treatment)
Oropharyngeal and oesophageal candidiasis
Systemic candidiasis
Cryptococcal disease management
Dermatophyte and other fungal infections

Available Variants

Fluconazole Tablets 150mg
Fluconazole Tablets 200mg
Fluconazole Capsules 150mg

Frequently Asked Questions

What is Fluconazole used for?

Fluconazole is a triazole antifungal used for vaginal and oropharyngeal candidiasis, systemic candidiasis, and other fungal infections, including opportunistic fungal infections associated with immunosuppression. A single 150 mg dose is a common regimen for uncomplicated vaginal candidiasis.

What strengths of Fluconazole does BioGalen manufacture?

BioGalen manufactures Fluconazole as tablets and capsules in 150 mg and 200 mg strengths, under WHO-GMP with CTD and ACTD dossiers available.

Is Fluconazole relevant for HIV-associated infections?

Yes. Fluconazole has an important role in managing opportunistic fungal infections in people living with HIV, including oral and oesophageal candidiasis and as part of cryptococcal disease management, supporting demand through retail and programme channels.

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