API products
Precision at the source: reliable API manufacturing for critical anti-infectives
Daptomycin - CMO
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 in adults.
Application: Administered systemically as intravenous infusion or injection.
Product grades
Non-sterile
Packaging sizes
2 kg, alternative packaging size can be discussed with Sales Representative
Packaging material
Primary Packaging: The final product is packaged in 2-ply polyethylene bags under vacuum and heat-sealed.
Secondary Packaging: The product is then packaged in aluminium foil bag and heat-sealed.
Tertiary Packaging: The product is then placed in aluminium container and sealed.
Shelf life
3 years
Storage conditions
2 - 8°C
Compliance
No monograph for daptomycin in either Ph. Eur. or USP available
Manufacturing site
CMO for Xellia Pharmaceuticals ApS
Release site
Testing site: Xellia Pharmaceuticals Ltd., Budapest, Hungary
Release site: Xellia Pharmaceuticals Private Limited, Hyderabad, India
Site registered
US FDA approved
Regulatory documentation
US Drug Master File (DMF)
DMF also available in other selected countries