Downloadables
Dosage form
Lyophilized vials
Strength
350 mg
500 mg
Batch size
350 mg
EU: 32150 vials
US: 32150 and 40000 vials
500 mg
EU: 22000 vials
US: 33400, 42000 and 53500 vials
Packaging sizes
1 vial/pack
Shelf life
36 months
Storage conditions
Between 2-8°C (36-46°F)
Compliance
No monograph for daptomycin in either Ph. Eur. or USP available
Manufacturing site
CMO for Xellia Pharmaceuticals ApS
Xellia Pharmaceuticals ApS, Copenhagen, Denmark (for US only)
Release site
CMO for Xellia Pharmaceuticals ApS
Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Site registered
EU GMP issued by Danish Medicines Agency
US FDA
Other health authorities
Regulatory documentation
EU dossier
US dossiers
RoW (Rest of the World) dossier
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