Generics
We manufacture our products by following our customers’ and health authorities’ most stringent requirements. DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD), and FDA (US DMF). Material and product testing is performed in line with the European and United States Pharmacopeias.
Monohydrate Form B
Therapeutic Area
Musculo-skeletal system
Status
Commercial
EU DMF readiness
US DMF readiness
CEP
Other documentation
Japanese DMF
Chinese DMF
Korean DMF
Brazilian DMF
CAS No.
138926-19-9
Reference Product
Available also in injectable form