Micafungin Intravenous (iv) Powder Generics - Manufacturers & Suppliers
Mycamine(US & EU)
| Product/Composition:- | Micafungin Intravenous (IV) Powder |
|---|---|
| Strength:- | 50 mg, 100 mg/vial |
| Form:- | Intravenous (IV) Powder |
| Reference Brands:- | Mycamine(US & EU) |
| MOQ | As per the manufacturer batch size |
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Micafungin inhibits fungal β-glucan synthase, disrupting cell wall synthesis and causing fungal cell death. It provides broad-spectrum activity against Candida and Aspergillus. Benefits include rapid action, high efficacy, minimal toxicity, and suitability for critically Ill patients, making it vital for treating severe invasive fungal infections.
Micafungin IV powder is approved in the EU and US for treating invasive candidiasis and antifungal prophylaxis. In the EU, Astellas’s Mycamine is regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval is based on extensive clinical data and biosimilarity assessments. Both regions require detailed regulatory dossiers for initial approval and continuous safety monitoring. For expert assistance with pharmaceutical dossiers, regulatory submissions, and compliance, visit PharmaTradz. We facilitate efficient market access for micafungin IV formulations, ensuring adherence to European and American standards for safe, effective antifungal therapy.