Downloadables
Dosage form
Lyophilized vials
Strength
350 mg
500 mg
Batch size
350 mg
40789 vials
500 mg
42592 vials
Packaging sizes
1 vial/pack
Shelf life
24 months
Storage conditions
EU dossier: Store below 25°C (77°F)
Compliance
No monograph for daptomycin in either Ph. Eur. or USP available
Manufacturing site
CMO for Xellia Pharmaceuticals ApS
Release site
CMO for Xellia Pharmaceuticals ApS
Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Site registered
EU GMP
US FDA
Other health authorities
Regulatory documentation
EU dossier (filing Q2, 2024)
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