Liposomal Amphotericin B Injectable

Form: Injection

Strength: 50 mg/vial

Reference Brands: AmBisome(US & EU)

Category: Anti-fungal

Liposomal Amphotericin B is approved in the EU and US for severe fungal infections. In the EU, Gilead’s AmBisome is regulated by EMA, supported by dossiers demonstrating safety, efficacy, and high manufacturing standards. In the US, FDA-approved AmBisome is backed by comprehensive clinical data, biosimilarity assessments, and pharmacovigilance. Both regions require detailed dossiers for initial approval and ongoing safety monitoring. For expert assistance with regulatory dossiers, compliance, and submissions, visit PharmaTradz. We facilitate efficient market access for Liposomal Amphotericin B, ensuring adherence to European and American standards for safe, effective antifungal therapy, reducing toxicity while maintaining efficacy in severe infections.