Knowde Enhanced TDS
Identification & Functionality
- Chemical Family
- Pharma & Nutraceuticals Functions
- Technologies
Features & Benefits
- Features
Product grades: Sterile, micronized .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
- Dosage Form
- Applications
Administered systemically as intramuscular injections and intravenous injections or infusions. Colistimethate
sodium can also be administered by inhalation or mixed with bone cement, as well used in ophthalmic formulations.
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, micronized
10 BOU*
100 BOU*
Sterile, non-micronized
15 BOU*
65 BOU*
Non-sterile, non-micronized
15 BOU*
65 BOU*- Packaging material
Primary: Almuinum containers with polyethylene insert and polypropylene lid
Secondary: Polystyrene
Storage & Handling
- Shelf-life
5 years
- Storage conditions
Below 25°C (77°F)