Downloadables
Product grades
Sterile, non-micronized
Non-sterile, non-micronized
Packaging sizes
2.15 kg
Packaging material
Primary: Aluminum containers with PE insert and polypropylene lid
Secondary: Polystyrene
Shelf life
3 years
Storage conditions
Do not store above 25 °C (77 °F)
Compliance
USP
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
Regulatory documentation
EU Drug Master File (DMF)
US Drug Master File (DMF)
DMF also available in other selected countries outside EU/US
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