Xelia Daptomycin

Xelia Daptomycin is a lipopeptide antibiotic active against Gram-positive bacteria: Such as Staphylococcus aureus (including methicillinresistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp.equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).

Functions: Antibiotic, Disinfectant

Dosage Form: Injectables

Certifications & Compliance: FDA Compliant, GMP

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Identification & Functionality

Pharma & Nutraceuticals Functions

Features & Benefits

Features

Product grades: Non-sterile
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 ,US FDA

Applications & Uses

Dosage Form
Applications

Administered systemically as intravenous infusion or injection

Properties

Physical Form

Regulatory & Compliance

Certifications & Compliance
Compliance

No monograph for daptomycin in either Ph. Eur. or USP available

Regulatory documentation

US Type II Drug Master File (DMF)
EU Drug Master File (DMF)

Packaging & Availability

Packaging Type
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 labeled

Storage & Handling

Shelf-life

3 years

Storage conditions

Below -20 °C (- 4°F)