PCAS

Overview

PCAS is an active pharmaceutical ingredient (API) supplier with 31 active FDA Type II Drug Master Files, covering APRACLONIDINE HYDROCHLORIDE; ARTICAINE HCL; BACLOFEN; CICLOPIROX; CINACALCET HCL; CLOMIPHENE CITRATE.

API / Drug Master Files

PCAS holds 31 active (60 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.

• ROLUPERIDONE HYDROCHLORIDEActive2021-11-22
• MEPIVACAINE HYDROCHLORIDEActive2020-09-10
• Estetrol MonohydrateActive2019-11-27
• ZUCLOMIPHENE CITRATEActive2018-06-04
• TIMOLOL MALEATE (7125)Active2015-07-07
• CINACALCET HCLActive2015-04-30
• ENCLOMIPHENE CITRATEActive2015-04-16
• CLOMIPHENE CITRATEActive2015-01-20
• ESOMEPRAZOLE SODIUMActive2014-06-09
• TAZAROTENEActive2011-07-25
• ESOMEPRAZOLE MAGNESIUM DIHYDRATEActive2011-06-09
• MIPRIActive2011-02-23
• OLOPATADINE HCLActive2010-06-18
• DISOPYRAMIDE PHOSPHATEActive2010-05-24
• GLYCOPYRROLATEActive2005-02-22

Showing 15 of 60 Drug Master Files.

FDA compliance signals

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