CAMBREX CHARLES CITY INC

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.

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.

• LISDEXAETAMINE 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

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