Ketoconazole Tablets

Form: Tablets

Strength: 200 mg

Reference Brands: Nizoral(US & EU)

Category: Anti-fungal

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.