Product/Composition:- | Amphotericin B injectable |
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Strength:- | 50 mg/vial, 50 mg/mL |
Form:- | Intravenous (IV) Injection |
Reference Brands:- | Fungizone(EU & US) |
MOQ | As per the manufacturer batch size |
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Amphotericin B binds to fungal cell membrane ergosterol, creating pores that disrupt membrane integrity and cause cell death. It provides broad-spectrum antifungal activity, effective against severe systemic infections. Benefits include potent efficacy, rapid action, and availability in lipid formulations for reduced toxicity, making it essential in managing life-threatening fungal diseases.
Amphotericin B is approved in the EU and US for treating severe systemic fungal infections. In the EU, brands like Fungizone (deoxycholate) and Ambisome (liposomal) are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA-approved formulations include Fungizone and AmBisome, backed by comprehensive clinical data and biosimilarity assessments. Both regions require detailed dossiers for initial approval and ongoing pharmacovigilance. For expert assistance with pharmaceutical dossiers, regulatory filings, and compliance, visit PharmaTradz. We facilitate efficient market entry for Amphotericin B formulations, ensuring adherence to European and American standards for safe, effective antifungal therapies.