Knowde Enhanced TDS
Identification & Functionality
- Chemical Family
- Pharma & Nutraceuticals Functions
- Technologies
Features & Benefits
- Features
Product grades : Non-sterile, non-micronized
Manufacturing site : Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Release site: Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Site registered : EU GMP certificate , US FDA, Other health authorities
Applications & Uses
- Markets
- Dosage Form
- Applications
Administered topically in the treatment of local infections, mainly external ear infections. Often formulated as otic
suspensions and solutions
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
10 BOU*
150 BOU*- Packaging material
Primary: Aluminum containers with a polyethylene insert and polypropylene lid
Secondary: Polystyrene
Storage & Handling
- Shelf-life
EU: 36 months
US: 48 months- Storage conditions
Below 25°C (77°F)