Downloadables
Product grades
Non-sterile
Packaging sizes
0.1 kgA (Kilogram Activity)
0.5 kgA (Kilogram Activity)
1 kgA (Kilogram Activity)
Packaging material
Primary: Polyethylene bag, with plastic seal
Secondary: Two polyethylene bags, heat sealed
Tertiary: Aluminum container
Shelf life
2 years
Storage conditions
Store refrigerated (2-8°C/ 36-46°F)
Compliance
Ph. Eur., USP, JP, CP
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)/Certificate of Suitability (CEP)
US Drug Master File (DMF)
China Drug Master File (CDMF)
Japan Drug Master File (JDMF)
DMF also available in other selected countries outside EU/US/China/Japan
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