Xelia Amphotericin B

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

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), United States Pharmacopeia (USP)

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Features & Benefits

Features

Product grades: Non-sterile
Manufacturing site :Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Release site :Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Site registered :Other health authorities

Applications & Uses

Markets
Applications
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.

Properties

Physical Form

Regulatory & Compliance

Certifications & Compliance
Grade
Compliance

Ph. Eur.
USP
JP

Regulatory documentation

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

US Drug Master File (DMF)
Letter of Access (LoA)

Packaging & Availability

Packaging Type
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

Storage & Handling

Shelf-life

2 Years

Storage conditions

Below 8°C (46°F)