Product/Composition:- | Voriconazole Intravenous (IV) Solution |
---|---|
Strength:- | 200 mg/100 mL |
Form:- | Intravenous (IV) Solution |
Reference Brands:- | Vfend(US & EU) |
MOQ | As per the manufacturer batch size |
Get Quote Send Enquiry on WhatsApp |
Voriconazole IV inhibits fungal cytochrome P450 14α-demethylase, disrupting ergosterol synthesis essential for fungal cell membranes. It provides broad-spectrum antifungal activity, rapid systemic treatment, and excellent tissue penetration. Benefits include high efficacy against invasive fungi like Aspergillus, making it vital for treating severe fungal infections.
Voriconazole IV solution is approved in the EU and US for severe fungal infections. In the EU, Pfizer’s Vfend IV is regulated by EMA, backed by dossiers demonstrating safety, efficacy, and quality. In the US, FDA approval is based on comprehensive clinical data, biosimilarity assessments, and ongoing pharmacovigilance. Both regions require detailed regulatory dossiers for initial approval and continuous safety monitoring. For expert assistance with regulatory dossiers, submissions, and compliance, visit PharmaTradz, your trusted partner in pharmaceutical regulatory solutions. We support efficient market access for voriconazole IV formulations, ensuring adherence to European and American standards for safe, effective antifungal therapy.