Fluconazole Oral Tablets

Form: Tablets

Strength: 50 mg, 100 mg, 150 mg, 200 mg

Reference Brands: Diflucan(EU & US)

Category: Anti-fungal

Fluconazole tablets are approved in the EU and US for treating fungal infections. In the EU, Pfizer’s Diflucan and generics are regulated by the EMA, supported by comprehensive dossiers demonstrating safety, efficacy, and manufacturing quality. In the US, the FDA approved Diflucan and generic versions based on detailed clinical data and biosimilarity assessments, with ongoing pharmacovigilance. Both regions require robust dossiers for approval and post-marketing surveillance. For expert assistance with pharmaceutical dossiers, regulatory submissions, and compliance, visit PharmaTradz, your trusted partner in regulatory solutions.