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.

Core services & business areas

API ManufacturingPharmaceutical Manufacturing

Active pharmaceutical ingredients supplied

Substances PMC ISOCHEM 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

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.

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