Ketoconazole

Antifungal · Tablets / Cream / Shampoo / Soap · 200mg (tablets), 2% (cream / shampoo / soap)

Trade Information

Minimum Order Qty	1,000,000 tablets; 100,000 units per topical form (cream / shampoo / soap)
Capacity	100 Million Tablets; 5 Million Topical Units per month
Strength	200mg (tablets), 2% (cream / shampoo / soap)
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
Lami tube (cream)
Bottle (shampoo)
Wrapped bar (soap)
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	Ketoconazole
Dosage Form	Tablets / Cream / Shampoo / Soap
Pack Size	10x10 (tablets), tube / bottle / bar / 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

Ketoconazole is an imidazole antifungal available in an unusually broad range of forms: tablets, cream, medicated shampoo, and antifungal soap. This breadth makes it a versatile antifungal for both medical and dermatological personal-care markets.

BioGalen manufactures the full Ketoconazole range. The shampoo and soap forms in particular lend themselves to private-label and branded personal-care lines, with flexible packaging across all forms.

Mechanism of Action

Ketoconazole is an imidazole antifungal that inhibits fungal cytochrome P450 14-alpha-demethylase, blocking the conversion of lanosterol to ergosterol. The resulting ergosterol depletion and accumulation of toxic sterol precursors damage the fungal cell membrane. Ketoconazole is active against many dermatophytes and yeasts, which makes its topical forms effective for skin fungal infections and, in shampoo and soap forms, for conditions such as seborrheic dermatitis and dandruff.

Indications

Skin fungal infections (ringworm, tinea)
Cutaneous candidiasis
Seborrheic dermatitis and dandruff (shampoo / soap)
Pityriasis versicolor
Certain systemic fungal infections (tablets, as directed)

Available Variants

Ketoconazole Tablets 200mg
Ketoconazole Cream 2%
Ketoconazole Shampoo 2%
Ketoconazole 2% with Zinc Pyrithione 1% Medicated Soap

Frequently Asked Questions

What forms of Ketoconazole does BioGalen manufacture?

BioGalen manufactures Ketoconazole in tablet, cream, medicated shampoo, and antifungal soap forms, serving both pharmacy and personal-care channels, all under WHO-GMP.

What is Ketoconazole used for?

Ketoconazole is an imidazole antifungal used for skin fungal infections such as ringworm and tinea, and in shampoo and soap forms for seborrheic dermatitis and dandruff. Tablet form is used for certain systemic fungal infections.

Does BioGalen offer private-label Ketoconazole shampoo and soap?

Yes. BioGalen offers private labelling and flexible packaging across all Ketoconazole forms, including shampoo and soap, supporting distributors and brand owners building consumer and pharmacy brands.

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