CAMBREX KARLSKOGA AB

Overview

CAMBREX KARLSKOGA AB is an active pharmaceutical ingredient (API) supplier with 7 active FDA Type II Drug Master Files, covering BUPIVACAINE BASE; BUPIVACAINE HYDROCHLORIDE; HYDROUS BENZOYL PEROXIDE; LIDOCAINE; LIDOCAINE HYDROCHLORIDE; MESALAMINE/5-AMINOSALICYLIC ACID.

API / Drug Master Files

CAMBREX KARLSKOGA AB holds 7 active (9 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.

  • RIVASTIGMINEActive2015-09-08
  • LIDOCAINE HYDROCHLORIDEActive2006-04-30
  • LIDOCAINEActive2006-04-30
  • BUPIVACAINE BASEActive2006-02-10
  • HYDROUS BENZOYL PEROXIDEActive2000-12-27
  • BUPIVACAINE HYDROCHLORIDEActive1985-08-27
  • MESALAMINE/5-AMINOSALICYLIC ACIDActive1985-01-24
  • OSPEMIFENEInactive2018-12-17
  • ISOSORBIDE-5-MONONITRATE/LACTOSEInactive1997-10-02

FDA compliance signals

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

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