Anidulafungin injection
Form: Intravenous (IV) Powder
Strength: 50 mg/vial
Reference Brands: Eraxis(US)
Category: Anti-fungal
Anidulafungin IV powder is approved in the EU and US for treating invasive fungal infections. In the EU, Pfizer’s Eraxis is regulated by EMA, supported by dossiers demonstrating safety, efficacy, and high manufacturing standards. In the US, FDA approval is based on comprehensive clinical data, biosimilarity assessments, and continuous pharmacovigilance. Both regions require detailed regulatory dossiers for initial approval and ongoing safety monitoring. For expert assistance with pharmaceutical dossiers, regulatory submissions, and compliance, visit PharmaTradz. We support efficient market access for anidulafungin IV formulations, ensuring adherence to European and American standards for safe, effective antifungal therapy.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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