PMC ISOCHEM

Overview

PMC ISOCHEM is an active pharmaceutical ingredient (API) supplier with 13 active FDA Type II Drug Master Files, covering ACETOHYDROXAMIC ACID; AMINOPYRROLAMIDE; AMIODARONE HYDROCHLORIDE; DIOSMINE; DOMIPHEN BROMIDE; ECONAZOLE NITRATE.

API / Drug Master Files

PMC ISOCHEM holds 13 active (13 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.

• ECONAZOLE NITRATEActive2013-01-31
• VITAMIN E POLYETHYLENE GLYCOL SUCCINATEActive2010-05-20
• NEFOPAM HYDROCHLORIDEActive2008-07-29
• TRIMEBUTINE MALEATEActive2006-09-12
• DIOSMINEActive2003-12-12
• PANTOPRAZOLE SODIUM SESQUIHYDRATEActive2002-02-28
• AMINOPYRROLAMIDEActive1998-05-15
• DOMIPHEN BROMIDEActive1996-10-08
• TERTIOBUTYL-4'-CHLORO-4-BUTYROPHENONEActive1995-09-19
• AMIODARONE HYDROCHLORIDEActive1988-08-02
• LOPERAMIDE HYDROCHLORIDEActive1988-04-28
• ACETOHYDROXAMIC ACIDActive1985-01-24
• INDORAMIN HYDROCHLORIDEActive1984-10-10

FDA compliance signals

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