Ketoconazole Tablets 200 mg Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 200 mg
Reference Brands: Nizoral(US & EU)
Category: Anti-fungal
Ketoconazole tablets inhibit fungal cytochrome P450 14α-demethylase, disrupting ergosterol synthesis essential for fungal cell membranes. They effectively treat systemic fungal infections, offering rapid, broad-spectrum antifungal activity. Benefits include oral administration, good absorption, and effectiveness against various fungal pathogens, making it vital for managing severe fungal diseases.
Product Description:
Ketoconazole tablets are approved in the EU and US for treating systemic fungal infections. In the EU, Janssen’s Nizoral tablets are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, the FDA-approved Nizoral and generic versions are based on comprehensive clinical data, biosimilarity assessments, and ongoing pharmacovigilance. Both regions require detailed regulatory dossiers for approval and post-marketing safety monitoring. For expert assistance with pharmaceutical dossiers, regulatory submissions, and compliance, visit PharmaTradz, your trusted partner in regulatory solutions, ensuring smooth market access and ongoing adherence to regulatory standards for ketoconazole tablets.
Ketoconazole Tablets — third party manufacturing & bulk supply
Ketoconazole Tablets 200 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Ketoconazole Tablets listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Ketoconazole Tablets →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Ketoconazole is used to treat fungal and yeast infections of the skin, including ringworm, jock itch, athlete’s foot, tinea versicolor, and cutaneous candidiasis. It is also used to manage dandruff and Seborrhoeic dermatitis by reducing fungal overgrowth on the skin or scalp.
Ketoconazole contains the active antifungal ingredient ketoconazole, an imidazole-derived compound. The formulation includes standard excipients suitable for topical skin or scalp application.
Common trade names include Nizoral, Ketozole, and Xolegel.
Branded Ketoconazole products like Nizoral are manufactured by different pharmaceutical companies depending on the region. Generic ketoconazole is produced by multiple GMP-approved global manufacturers.
The generic name is ketoconazole.
Brand names include Nizoral, Ketozole, and Xolegel.
Ketoconazole is manufactured in various GMP-certified facilities around the world. Both branded and generic versions are produced in multiple countries depending on market authorization.
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