Ketoconazole Topical Cream/Shampoo Suppliers & Bulk Manufacturers
Available Forms: Topical Creams/Ointments/Shampoo
Available Strengths: 2%
Reference Brands: Nizoral(US & EU)
Category: Anti-fungal
Ketoconazole topical gel inhibits fungal cytochrome P450 14α-demethylase, disrupting ergosterol synthesis and fungal cell membrane integrity. It effectively treats skin infections like athlete’s foot and seborrheic dermatitis. Benefits include targeted application, fast relief, minimal systemic absorption, and broad antifungal activity for safe, effective management of superficial fungal skin conditions. Ketoconazole Topical cream/shampoo is available in Topical Creams/Ointments/Shampoo and strengths such as 2%. 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 Topical cream/shampoo 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 Topical cream/shampoo 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 topical gel is approved in the EU and US for treating fungal skin infections. In the EU, Janssen’s Nizoral gel is regulated by EMA, supported by dossiers demonstrating safety, efficacy, and quality. In the US, FDA approval is based on comprehensive clinical data, biosimilarity, and pharmacovigilance. Both regions require detailed dossiers for initial approval and ongoing safety monitoring. For expert assistance with pharmaceutical dossiers, regulatory filings, and compliance, visit PharmaTradz, your trusted partner in regulatory solutions. We help ensure efficient market access and adherence to European and American regulatory standards, supporting your product’s path to global success.
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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