ISOCHEM SA

Overview

ISOCHEM SA is an active pharmaceutical ingredient (API) supplier with 7 active FDA Type II Drug Master Files, covering AMBOX; BUFLOMEDIL HYDROCHLORIDE; EPAL-NCA; FLAVOXATE HYDROCHLORIDE; GEIBROZIL; METHYL-3-FLAVONE-8-CARBOXYLIC ACID.

API / Drug Master Files

ISOCHEM SA holds 7 active (22 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.

• SOLIFENACIN SUCCINATEActive2014-11-19
• BUFLOMEDIL HYDROCHLORIDEActive2008-07-05
• AMBOXActive2006-06-19
• GEIBROZILActive2005-02-03
• EPAL-NCAActive2001-01-23
• METHYL-3-FLAVONE-8-CARBOXYLIC ACIDActive1993-08-25
• FLAVOXATE HYDROCHLORIDEActive1991-04-02
• FENOLDOPAM MESYLATE USPInactive2006-09-02
• CARISOPRODOLInactive2006-05-05
• FLUMECINOLInactive1996-02-22
• MICONAZOLE NITRATEInactive1992-06-24
• 1,4-DITHIA-7-AZASPIRO[4,4]NONANE-8-(S)CARBOXYLIC ACID-HYDROBRInactive1991-09-06
• PHARMACEUTICAL BRAND PROTECTION AND ANTI-COUNTERFEITING INSTRUMENTATION AND PROCESSInactive1990-06-25
• TERFENADINEInactive1990-06-22
• FACILITIES AND OPERATING PROCEDURES IN GENNEVILLER, FRANCEInactive1990-05-09

Showing 15 of 22 Drug Master Files.

FDA compliance signals

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