Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Chemical Family
- Pharma & Nutraceuticals Functions
- Technologies
- Product Families
Features & Benefits
- Features
Product grades Sterile, micronized Non-sterile, micronized Non-sterile, 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
- Applications
- Dosage Form
- Applications
Administered systemically as intravenous infusions, intramuscular or intrathecal injections and locally as eye drops
or subconjunctival 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 sizes
- Sterile Micronized
1 BOU*
5 BOU*
10 BOU*- Sterile Non-micronized
1 BOU*
10 BOU*- Non-sterile Micronized
1 BOU*
5 BOU*
10 BOU*
25 BOU*- Non-sterile Non-micronized
10 BOU*
- Packaging material
Primary: Aluminum containers with PE insert and polypropylene lid
Secondary: Polystyrene
Storage & Handling
- Shelf-life
Sterile: 24 months
Non-sterile: 5 years
USP grade for ROW and EP grade: 5 years- Storage conditions
Below 25°C (77°F)