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.
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Manufacturing site |
Xellia Pharmaceuticals ApS, Copenhagen, Denmark |
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Release site |
Xellia Pharmaceuticals ApS, Copenhagen, Denmark |
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EU GMP issued by Danish Medicines Agency US FDA Other health authorities |
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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 |
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