Fosfomycin Iv Generics - Manufacturers & Suppliers
Zyflo(US)
| Product/Composition:- | Fosfomycin IV |
|---|---|
| Strength:- | 2 g, 4g per vial |
| Form:- | Intravenous (IV) |
| Reference Brands:- | Zyflo(US) |
| MOQ | As per the manufacturer batch size |
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Fosfomycin IV inhibits bacterial cell wall synthesis by targeting the enzyme MurA, preventing peptidoglycan formation. It offers broad-spectrum activity against resistant gram-negative bacteria and carbapenemase producers. Benefits include rapid bactericidal action, high tissue penetration, and effective treatment of complicated urinary and systemic infections, especially when resistance limits other options.
Fosfomycin IV is approved in the EU and US for complicated urinary tract infections and systemic bacterial infections. In the EU, brands like Fosfomycin are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval relies on extensive clinical data; generics are available. Both regions require detailed dossiers, including clinical trial results, manufacturing practices, and pharmacovigilance plans for approval and ongoing safety. To navigate complex regulatory requirements, optimize dossier submission, and ensure compliance, visit PharmaTradz. We facilitate seamless market access for fosfomycin IV, ensuring adherence to European and US standards for safe, effective antimicrobial therapy.