DERIVADOS QUIMICOS SAU

Overview

DERIVADOS QUIMICOS SAU is an active pharmaceutical ingredient (API) supplier with 9 active FDA Type II Drug Master Files, covering BUTOCONAZOLE NITRATE; CICLETANINE HYDROCHLORIDE; CYCLOBENZAPRINE HYDROCHLORIDE; FENOFIBRATE; KETOCONAZOLE; MELOXICAM.

API / Drug Master Files

DERIVADOS QUIMICOS SAU holds 9 active (12 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.

• MILNACIPRAN HYDROCHLORIDEActive2012-11-07
• RACEPINEPHRINE HYDROCHLORIDEActive2012-03-12
• CICLETANINE HYDROCHLORIDEActive2011-02-11
• MELOXICAMActive2010-09-22
• FENOFIBRATEActive2010-08-04
• CYCLOBENZAPRINE HYDROCHLORIDEActive2010-02-05
• TERCONAZOLEActive2007-07-30
• BUTOCONAZOLE NITRATEActive2005-11-29
• KETOCONAZOLEActive2001-01-19
• DIOXANONEInactive2011-11-07
• BUPROPION HYDROCHLORIDEInactive2010-04-22
• FACILITIES AND OEPRATING PROCEDURES IN MURCIA, SPAINInactive1991-12-10

FDA compliance signals

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