Knowde Enhanced TDS
Identification & Functionality
- Chemical Family
- Pharma & Nutraceuticals Functions
- Technologies
Features & Benefits
- Features
- Product grades :Sterile, micronized Non-sterile, micronized Non-sterile, non-micronized
- Manufacturing site: Xellia (Taizhou) Pharmaceuticals Co., Ltd., China (non-sterile) CMO for 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
Applications & Uses
- Markets
- Dosage Form
- Applications
Administered typically as combination drug product used in topical creams, powders, ointments and solutions.
Properties
Regulatory & Compliance
- Certifications & Compliance
- Grade
- Compliance
Ph. Eur.
USP- Regulatory documentation
EU Drug Master File (DMF)/Certificate of Suitability (CEP) - non-sterile only
US Drug Master File (DMF)
Letter of Access (LoA)
Packaging & Availability
- Packaging Type
- Packaging sizes
- Sterile non-micronized
750 g
- 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: 5 years
Sterile: EU (36 months), US (48 months)- Storage conditions
Below 25°C (77°F)