Amphotericin B Injectable Suppliers & Bulk Manufacturers
Available Forms: Intravenous (IV) Injection
Available Strengths: 50 mg/vial, 50 mg/mL
Reference Brands: Fungizone(EU & US)
Category:
Anti-fungal
Amphotericin B binds to fungal cell membrane ergosterol, creating pores that disrupt membrane integrity and cause cell death. It provides broad-spectrum antifungal activity, effective against severe systemic infections. Benefits include potent efficacy, rapid action, and availability in lipid formulations for reduced toxicity, making it essential in managing life-threatening fungal diseases.
Amphotericin B injectable is available in Intravenous (IV) Injection
and strengths such as 50 mg/vial, 50 mg/mL.
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, Amphotericin B injectable 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) |
Amphotericin B injectable 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:
Amphotericin B is approved in the EU and US for treating severe systemic fungal infections. In the EU, brands like Fungizone (deoxycholate) and Ambisome (liposomal) are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA-approved formulations include Fungizone and AmBisome, backed by comprehensive clinical data and biosimilarity assessments. Both regions require detailed dossiers for initial approval and ongoing pharmacovigilance. For expert assistance with pharmaceutical dossiers, regulatory filings, and compliance, visit PharmaTradz. We facilitate efficient market entry for Amphotericin B formulations, ensuring adherence to European and American standards for safe, effective antifungal therapies.
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