Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Pharma & Nutraceuticals Functions
- Technologies
- Product Families
Features & Benefits
- Features
Product grades Sterile, non-micronized Non-sterile, non-micronized
Manufacturing site: Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Release site: Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Site registered: EU GMP issued by Danish Medicines Agency , US FDA, Other health authorities
Applications & Uses
- Markets
- Applications
- Dosage Form
- Applications
Administered systemically by intramuscular injections or intravenous infusions. Can be mixed with bone cement.
Properties
Regulatory & Compliance
- Certifications & Compliance
- Grade
- Compliance
USP
- Regulatory documentation
EU Drug Master File (DMF)
US Drug Master File (DMF)
Letter of Access (LoA)
Packaging & Availability
- Packaging sizes
Sterile, non-micronized
2.15 kg
Non-sterile, non-micronized
2.15 kgA*- Packaging material
Sterile, non-micronized
Primary: Aluminum containers with PE insert
and polypropylene lid
Secondary: Polystyrene
Non-sterile, non-micronized
Primary: Aluminum containers with PE insert
Secondary: Polystyrene
Storage & Handling
- Shelf-life
3 years
- Storage conditions
Below 25°C (77°F)