Daptomycin* is a lipopeptide antibacterial agent active against Gram-positive bacteria.
Indication: Used in the treatment of complicated skin and skin structure/soft-tissue infections caused by susceptible isolates of Gram-positive bacteria: Staphylococcus aureus (including MRSA-methicillin-resistant Staphylococcus aureus), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae supsp. equisimilis and Enterococcus faecalis (vancomycinsusceptible isolates only).
Additionally used in the treatment of patients with bloodstream infections (bacteremia), including patients with right-sided infective endocarditis caused by Staphylococcus aureus.
Application: Administered as intravenous infusions or injections..
Dosage form |
Lyophilized vials |
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Strength |
350 mg 500 mg |
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Compliance |
No monograph for Daptomycin in either Ph. Eur or USP available |
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Manufacturing site |
CMO for Xellia Pharmaceuticals ApS |
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Release site |
CMO for Xellia Pharmaceuticals ApS |
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Site registered |
EU GMP issued by Medicines and Healthcare products Regulatory Agency US FDA Other Health Authorities |
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Batch size |
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Regulatory documentation |
EU dossier US dossier RoW* dossier |
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Packaging sizes |
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Shelf life |
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Storage conditions |
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* Products protected by valid patents are not offered for sale in countries, where the sale of such products constitutes a patent infringement.
* * Rest of the world
