Drug Master Files

Drug Master Files Page
Expertise in Drug Master File preparation

Archimica has extensive experience in the preparation of Drug Master Files and can assist our customers in this phase of the commercialization process. Below is a listing of Drug Master Files which we currently hold.

Product
DMF Status
France
BETAINE CITRATE French DMF
CIBENZOLINE SUCCINATE Technical Package
DIFEMERINE EU DMF
HEXETIDINE COS
MORNIFLUMATE Technical Package
NIFLUMIC ACID Technical Package
PROPACETAMOL French DMF
   
USA
CHOLINE FENOFIBATE Under Filling
DEXMETHYLPHENIDATE US DMF
METHYLPHENIDATE US/EU DMF
   
Italy
ATOMOXETINE PILOT QUANTITIES
CHLORTALIDONE USDMF - EDMF - COS
FEXOFENADINE PILOT QUANTITIES
FLUTAMIDE USDMF - EDMF - COS
MINOCYCLINE HYDROCHLORIDE USDMF - DMF- COS
OXACARBAZEPINE US/EU DMF
PROPOFOL USDMF - EDMF - COS
RIBAVIRIN US/EU DMF
TERAZOSIN US/EU DMF
   
UK
CARBIMAZOLE EU DMF
DIETHYLAMINE SALICYLATE EU DMF
ETHYLENE GLYCOL MONOSALICYLATE EU DMF
ETHYL SALICYLATE  
FLUCYTOSINE US/EU DMF
ISOSORBIDE DINITRATE US/EU DMF
ISOSORBIDE-5-MONONITRATE US/EU DMF
SALICYLIC ACID COS