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
Applications & Uses
- Markets
- Applications
- Dosage Form
- Applications
Administered systemically as intravenous infusions and as capsules for oral administration. IV form can also be used
orally for the treatment of Clostridium difficile infections.
Properties
Regulatory & Compliance
- Certifications & Compliance
- Grade
- Compliance
Ph. Eur.
USP- Regulatory documentation
EU Drug Master File (DMF)/Certificate of Suitability (CEP)
US Drug Master File (DMF)
Letter of Access (LoA)
Packaging & Availability
- Packaging sizes
Sterile, non-micronized
0.5 kgA*
3 kgA*
8 kgA*
Non-sterile, non-micronized
0.5 kgA*
3 kgA*
8 kgA*
10 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 and
polypropylene lid
Secondary: Polystyrene
Storage & Handling
- Shelf-life
2 years (according to EU)
3 years (according to US)- Storage conditions
Below 8°C (46°F)