Micafungin Intravenous (Iv) Powder Suppliers & Bulk Manufacturers
Available Forms: Intravenous (IV) Powder
Available Strengths: 50 mg, 100 mg/vial
Reference Brands: Mycamine(US & EU)
Category:
Anti-fungal
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 Intravenous (IV) Powder is available in Intravenous (IV) Powder
and strengths such as 50 mg, 100 mg/vial.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Micafungin Intravenous (IV) Powder is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Micafungin Intravenous (IV) Powder can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
Product Description:
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.
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