Product sheet
Safety data sheet
Product grades
Sterile, micronized
Non-sterile, micronized
Non-sterile, non-micronized
Packaging sizes
Sterile, micronized
750 g
2 kg
Non-sterile, micronized
1 kg
5 kg
15 kg
Non-sterile, non-micronized
1 kg
5 kg
15 kg
Packaging material
Sterile, micronized
Primary: Aluminum container with reinforced butyl lid and tear-off aluminum seal
Secondary: Polystyrene
Non-sterile, micronized
Primary: Polyethylene bag closed with cable tie
Secondary: Heat sealed multi-layer laminated aluminum bag
Non-sterile, non-micronized
Primary: Polyethylene bag closed with cable tie
Secondary: Heat sealed multi-layer laminated aluminum bag
Shelf life
Sterile, micronized
3 years
Non-sterile, micronized
4 years
Non-sterile, non-micronized
4 years
Storage conditions
Store refrigerated (2-8°C/ 36-46°F)
Compliance
Ph. Eur., USP, JP, CP
Manufacturing site
Xellia (Taizhou) Pharmaceuticals Co., Ltd., China (non-sterile)
Xellia Pharmaceuticals ApS, Copenhagen, Denmark (sterilisation 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 health authorities
Regulatory documentation
EU Drug Master File (DMF)/Certificate of Suitability (CEP)
US Drug Master File (DMF)
China Drug Master File (CDMF for non-sterile grade)
Japan Drug Master File (JDMF for non-sterile grade)
DMF also available in other selected countries outside EU/US/China
Other documentations
Written confirmation for import into EU
Chinese Manufacturing License (Taizhou Site)
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