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 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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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.
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