Itraconazole Capsules

Form: Oral Capsules

Strength: 100 mg

Reference Brands: Sporanox(US & EU)

Category: Anti-fungal

Itraconazole capsules are approved in the EU and US for treating fungal infections. In the EU, Janssen’s Sporanox and generics are regulated by EMA, backed by comprehensive dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, the FDA approved Sporanox and generic versions based on detailed clinical data, biosimilarity assessments, and ongoing pharmacovigilance. Both regions require robust regulatory dossiers for initial approval and continued safety monitoring. For expert assistance with pharmaceutical dossiers, regulatory submissions, and compliance, visit PharmaTradz, your trusted partner in regulatory solutions, helping facilitate timely market access for itraconazole capsules.