Ketoconazole Tablets 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. Ketoconazole Tablets is available in Tablets and strengths such as 200 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Ketoconazole Tablets is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Ketoconazole Tablets can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
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.
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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