Our products / APIs
Daptomycin
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.
Downloadables
Product grades
Non-sterile
Packaging sizes
Packaging size can be discussed with your Sales Representative
Packaging material
Primary: Aluminum foil bag (laminated with Polyethylene on the inner side and Polyester on outer side) and heat-sealed
Secondary: Primary bag placed into second identical bag also heat-welded and labelled
Shelf life
3 years
Storage conditions
Store in a freezer (-20±5°C / 5 to -13°F)
Compliance
No monograph for daptomycin in either Ph. Eur. or USP available
Manufacturing site
Xellia Pharmaceuticals Ltd., Budapest, Hungary
Release site
Xellia Pharmaceuticals Ltd., Budapest, Hungary
Site registered
EU GMP issued by Hungarian National Institute of Pharmacy recognized by FDA from March 1st 2018 according to Mutual Recognition Agreement (MRA)
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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