CAMBREX CHARLES CITY INC

United States cambrex.com

Overview

CAMBREX CHARLES CITY INC is an active pharmaceutical ingredient (API) supplier with 30 active FDA Type II Drug Master Files, covering 5-AMINOSALICYLIC ACID; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE L- ASPARTATE; AMPHETAMINE SULFATE; ARIPIPRAZOLE; BUPRENORPHINE HYDROCHLORIDE.

Core services & business areas

API Manufacturing

Active pharmaceutical ingredients supplied

Substances CAMBREX CHARLES CITY INC 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.

AripiprazoleLevetiracetamCarvedilolCetirizineErlotinib HydrochlorideOndansetronTorsemideMethylphenidateHydrocodoneFentanylLapatinib DitosylatePhenylephrine HydrochlorideOfloxacinBuprenorphine HydrochlorideAmphetamine AspartateButalbitalDextroamphetamine SaccharateDiclofenac EpolamineSulfasalazineDextroamphetamineSodium OxybatePropoxyphene HydrochlorideAmphetamine SulfatePhentermine HydrochlorideDextromethorphan PolistirexPropoxyphene NapsylateSufentanilCalcium OxybatePotassium OxybateSufentanil CitrateMagnesium Oxybate

API / Drug Master Files

CAMBREX CHARLES CITY INC holds 30 active (45 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.

  • LISDEXAMFETAMINE DIMESYLATE (LDX)Active2026-02-24
  • SULFASALAZINE, PURIFIEDActive2025-10-17
  • BUPRENORPHINE HYDROCHLORIDEActive2023-02-21
  • CALCIUM OXYBATEActive2022-06-10
  • MAGNESIUM OXYBATEActive2022-05-26
  • POTASSIUM OXYBATEActive2022-04-26
  • SODIUM OXYBATEActive2022-04-25
  • ERLOTINIB HYDROCHLORIDEActive2015-09-16
  • AMPHETAMINE L- ASPARTATEActive2015-09-16
  • LAPATINIB DITOSYLATE MONOHYDRATEActive2015-09-15
  • HYDROCODONE BITARTRATE HEMIPENTAHYDRATEActive2015-05-06
  • OPIUM TINCTURE 2%Active2013-10-10
  • DICLOFENAC EPOLAMINEActive2012-05-31
  • NICOTINE RESINATE, 20%Active2008-07-01
  • ARIPIPRAZOLEActive2005-09-13

Showing 15 of 45 Drug Master Files.

FDA compliance signals

1 FDA enforcement record linked to this company.

  • recall — Class II2017-02-01

    Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.

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