Posaconazole Intravenous (iv) Solution Generics - Manufacturers & Suppliers
Noxafil(US & EU)
| Product/Composition:- | Posaconazole Intravenous (IV) Solution |
|---|---|
| Strength:- | 300 mg/100 mL |
| Form:- | Intravenous (IV) solution |
| Reference Brands:- | Noxafil(US & EU) |
| MOQ | As per the manufacturer batch size |
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Posaconazole IV inhibits fungal cytochrome P450 14α-demethylase, disrupting ergosterol synthesis and fungal cell membrane formation. It provides broad-spectrum antifungal activity, rapid systemic absorption, and excellent tissue penetration. Benefits include effective treatment of invasive fungal infections, reliable intravenous delivery, and high bioavailability, crucial for managing severe fungal diseases.
Posaconazole IV is approved in the EU and US for treating invasive fungal infections. In the EU, MSD’s Noxafil IV is regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval is based on extensive clinical data, biosimilarity assessments, and ongoing pharmacovigilance. Both regions require detailed regulatory dossiers for initial approval and continued safety monitoring. For expert assistance with pharmaceutical dossiers, regulatory submissions, and compliance, visit PharmaTradz. We support efficient market access for posaconazole IV formulations, ensuring adherence to European and American standards for safe, effective antifungal therapy.