Product/Composition:- | Anidulafungin injection |
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Strength:- | 50 mg/vial |
Form:- | Intravenous (IV) Powder |
Reference Brands:- | Eraxis(US) |
MOQ | As per the manufacturer batch size |
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Anidulafungin inhibits fungal β-glucan synthase, disrupting cell wall synthesis and leading to fungal cell death. It offers broad-spectrum activity against invasive Candida and Aspergillus infections, with rapid onset, minimal toxicity, and high efficacy. Its safety profile and effectiveness make it essential for treating life-threatening fungal diseases.
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.