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.

Core services & business areas

Active pharmaceutical ingredients supplied

Substances ISOCHEM SA 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

ISOCHEM SA holds 2 active (16 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.

• BUFLOMEDIL HYDROCHLORIDEActive2008-07-05
• FLAVOXATE HYDROCHLORIDEActive1991-04-02
• FENOLDOPAM MESYLATE USPInactive2006-09-02
• 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
• DILTIAZEM HCLInactive1988-04-07
• QUINIDINE BISULPHATEInactive1988-03-03
• ACCEPTANCE TESTING OF HFA-134A(1,1,1,2-TETRAFLUOROETHANE)Inactive1987-11-27
• FENOPROFEN CALCIUM USPInactive1987-08-27
• 1-METHYL AMINO-1-METHYL-THIO-2-NITROETHYLENE ANDInactive1985-05-30
• MANUFACTURING PROCEDURES FOR ETINTIDINE HYDROCHLORIDEInactive1984-03-02

Showing 15 of 16 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.