UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)

Overview

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA) is an active pharmaceutical ingredient (API) supplier with 19 active FDA Type II Drug Master Files, covering ACYCLOVIR; ALLOPURINOL; Bicalutamide; CIMETIDINE USP; CLINDAMYCIN PHOSPHATE USP; DOXYLAMINE SUCCINATE USP.

API / Drug Master Files

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA) holds 19 active (49 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.

• SITAGLIPTIN PHOSPHATEActive2023-02-21
• RANOLAZINEActive2017-08-01
• QUETIAPINE FUMARATEActive2016-11-28
• ESOMEPRAZOLE MAGNESIUM DIHYDRATEActive2016-04-15
• SOLIFENACIN SUCCINATEActive2015-07-22
• MIVACURIUM CHLORIDEActive2014-06-19
• BicalutamideActive2007-11-30
• FAMOTIDINE USPActive2006-10-30
• LANSOPRAZOLEActive2004-10-28
• TROPICAMIDEActive2004-10-15
• OMEPRAZOLEActive2004-03-23
• NIMODIPINE (MICRONIZED)Active2003-11-03
• ALLOPURINOLActive2003-03-19
• KETOCONAZOLEActive2002-10-17
• CLINDAMYCIN PHOSPHATE USPActive1999-09-23

Showing 15 of 49 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to UNION QUIMICO FARMACEUTICA SA (UQUIFA SA) in our records. PharmaTek screens the full directory against live FDA enforcement data.