Daptomycin is a lipopeptide antibiotic active against gram-positive bacteria such as Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp.equisimilis and Enterococcus faecalis (vancomycin-susceptible isolates only).
Indication: Used in the treatment of complicated skin and skin structure/soft-tissue infections caused by susceptible isolates of gram-positive bacteria in adult and pediatric patients and in the treatment of patients with Staphylococcus aureus (including MRSA-methicillin-resistant strains) bacteremia, as well as right-sided endocarditis.
Application: Administered systemically as intravenous infusion or injection.
Product grades |
Non-sterile | ||
Compliance |
No monograph for daptomycin in either Ph. Eur. or USP available |
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Manufacturing site |
Xellia Pharmaceuticals Ltd., Budapest, Hungary |
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Release site |
Xellia Pharmaceuticals Ltd., Budapest, Hungary |
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Site registered |
EU GMP issued by Hungarian National Institute of Pharmacy recognized by FDA from March 1st 2018 according to Mutual Recognition Agreement (MRA) |
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Regulatory documentation |
US Drug Master File (DMF) EU Drug Master File (DMF) DMF also available in other selected countries outside EU/US |
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