ORGAPHARM SAS

Overview

ORGAPHARM SAS is an active pharmaceutical ingredient (API) supplier with 6 active FDA Type II Drug Master Files, covering 3-FORMYL-5-METHOXYINDOLE INTERMEDIATE; ARTICAINE HYDROCHLORIDE DRUG SUBSTANCE; ETHIONAMIDE DRUG SUBSTANCE; HEMATOPORPHYRIN DIHYDROCHLORIDE; PROTOPORPHYRIN IX DIMETHYL ESTER (PPIX-DME); THIOTHIXENE.

API / Drug Master Files

ORGAPHARM SAS holds 6 active (8 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• ETHIONAMIDE DRUG SUBSTANCEActive2010-03-17
• PROTOPORPHYRIN IX DIMETHYL ESTER (PPIX-DME)Active2007-03-16
• 3-FORMYL-5-METHOXYINDOLE INTERMEDIATEActive2005-10-07
• ARTICAINE HYDROCHLORIDE DRUG SUBSTANCEActive2003-03-18
• HEMATOPORPHYRIN DIHYDROCHLORIDEActive1994-07-26
• THIOTHIXENEActive1984-09-28
• FENOFIBRATE DRUG SUBSTANCEInactive1999-05-26
• METHYL SULFONAMIDE INDOLE-2- CAROXYLIC ACIDInactive1994-06-02

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to ORGAPHARM SAS in our records. PharmaTek screens the full directory against live FDA enforcement data.