Knowde Enhanced TDS
Identification & Functionality
- Chemical Family
- Pharma & Nutraceuticals Functions
- Technologies
Features & Benefits
- Features
Product grades : Sterile, non-micronized Non-sterile, micronized Non-sterile, non-micronized
Manufacturing site : Xellia (Taizhou) Pharmaceuticals Co., Ltd., China (non-sterile) Xellia Pharmaceuticals ApS, Copenhagen, Denmark (sterilization only)
Release site : Xellia (Taizhou) Pharmaceuticals Co., Ltd., China (non-sterile) Xellia Pharmaceuticals ApS, Copenhagen, Denmark (sterile)
Site registered : EU GMP issued by Danish Medicines Agency US FDA
- Other documentation
Written confirmation for import into EU
Chinese Manufacturing License (Taizhou site)
Applications & Uses
- Markets
- Applications
Administered typically as a combination drug product used in topical creams, powders, ointments and
solutions. Bacitracin is also administered systemically as intramuscular injections.
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 Type
- Packaging sizes
- Sterile non-micronized
750 g
2 kg- Non-sterile micronized & non-micronized
1 kg
5 kg
15 kg- Packaging material
- Sterile non-micronized :
Primary: Aluminum container with reinforced butyl lid and tear-off aluminum seal
Secondary: Polystyrene- Non-sterile micronized & non-micronized
Primary: Polyethylene bag closed with cable tie
Secondary: Heat sealed multi-layer laminated aluminum bag
Storage & Handling
- Shelf-life
Non-sterile: 4 years
Sterile: 3 years- Storage conditions
Below 8°C (46°F)