Ketoconazole Topical Cream/Shampoo

Form: Topical Creams/Ointments/Shampoo

Strength: 2%

Reference Brands: Nizoral(US & EU)

Category: Anti-fungal

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.