Amphotericin B injectable
Form: Intravenous (IV) Injection
Strength: 50 mg/vial, 50 mg/mL
Reference Brands: Fungizone(EU & US)
Category: Anti-fungal
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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