API products
Precision at the source: reliable API manufacturing for critical anti-infectives
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
Non-sterile
Packaging sizes
0.1 kgA (Kilogram Activity)
0.5 kgA (Kilogram Activity)
1 kgA (Kilogram Activity)
Packaging material
Primary: Polyethylene bag, with plastic sealSecondary: Two polyethylene bags, heat sealedTertiary: Aluminum container
Shelf life
2 years
Storage conditions
Store refrigerated (2-8°C/ 36-46°F)
Compliance
Ph. Eur., USP, JP, CP
Manufacturing site
Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Release site
Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Site registered
EU GMP issued by Danish Medicines AgencyUS FDAOther 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/Japan