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.

Core services & business areas

Active pharmaceutical ingredients supplied

Substances ORGAPHARM SAS is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

API / Drug Master Files

ORGAPHARM SAS holds 5 active (6 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
• THIOTHIXENEActive1984-09-28
• 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.