Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Pharma & Nutraceuticals Functions
- Technologies
- Product Families
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
- Markets
- Applications
- Dosage Form
- Applications
Administered systemically as intravenous infusion or injection
Properties
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)