Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Pharma & Nutraceuticals Functions
- Technologies
- Product Families
Features & Benefits
- Features
Product grades: Non-sterile, non-micronized
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 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
JP- Regulatory documentation
EU Drug Master File (DMF)/Certificate of Suitability (CEP)
US Drug Master File (DMF)
Letter of Access (LoA)
Packaging & Availability
- Packaging Type
- Packaging sizes
Agreed upon with customer
- Packaging material
Primary: Aluminum bag laminated with Polyethylene, heat sealed
Secondary: Same as primary
Storage & Handling
- Storage conditions
2 years (according to EU)
3 years (according to US)- Storage conditions
Below 8°C (46°F)