Downloadables
Product grades
Non-sterile
Packaging sizes
100 g
500 g
Packaging material
Primary: Polyethylene bag closed with twist tie plastic clip
Secondary: Heat sealed multi-layer laminated aluminum bag
Shelf life
3 years
Storage conditions
Do not store above 25 °C (77 °F)
Compliance
Ph. Eur., USP
Manufacturing site
Xellia Pharmaceuticals Ltd., Budapest, Hungary
Release site
Xellia Pharmaceuticals Ltd., Budapest, Hungary
Site registered
EU GMP issued by Hungarian National Institute of Pharmacy recognized by FDA from March 1st 2018 according to Mutual Recognition Agreement (MRA)
Regulatory documentation
EU Drug Master File (DMF)/Certificate of Suitability (CEP)
US Drug Master File (DMF)
DMF also available in other selected countries outside EU/US
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