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Amphotericin B

Amphotericin B is a mixture of polyenes active against a wide variety of fungi e.g. Aspergillus, Candida and Cryptococcus species. 

Indication: Used in the treatment of severe, invasive, potentially life-threatening fungal infections (mycosis) typically in immunocompromised patients.

Applications: Administered intravenously as a colloidal complex with sodium deoxycholate or as a liposomal formulation. The low germ and endotoxin content makes Xellia’s amphotericin B particularly suitable for parenteral use.


Product grades



Ph. Eur.




Manufacturing site

Xellia Pharmaceuticals ApS, Copenhagen, Denmark

Release site

Xellia Pharmaceuticals ApS, Copenhagen, Denmark

Site registered

EU GMP issued by Danish Medicines Agency


Other health authorities

Regulatory documentation

EU Drug Master File (DMF)/Certificate of Suitability (CEP)

US Drug Master File (DMF)

China Drug Master File (CDMF)

Japan Drug Master File (JDMF)

DMF also available in other selected countries outside EU/US/China

Packaging sizes

0.1 kgA*

0.5 kgA*

1 kgA*

Packaging material

Primary: Polyethylene bag, with plastic seal

Secondary: Two polyethylene bags, heat sealed

Tertiary: Aluminum container

Shelf life

2 years

Storage conditions

Store refrigerated (2-8°C/ 36-46°F)

* Kilogram Activity