PROCOS SPA

Overview

PROCOS SPA is an active pharmaceutical ingredient (API) supplier with 20 active FDA Type II Drug Master Files, covering CARGLUMIC ACID; CHLOPHEDIANOL HYDROCHLORIDE; DALFAMPRIDINE; EFINACONAZOLE; EMBUTRAMIDE; FELBAMATE.

API / Drug Master Files

PROCOS SPA holds 20 active (40 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.

• CARGLUMIC ACIDActive2023-07-12
• ISTRADEFYLLINEActive2023-04-12
• LOFEXIDINE HYDROCHLORIDEActive2022-10-25
• MIDOSTAURINActive2020-11-20
• LURASIDONE HYDROCHLORIDEActive2019-06-05
• EFINACONAZOLEActive2017-11-15
• PIRFENIDONEActive2017-07-31
• GUANFACINE HYDROCHLORIDEActive2014-05-19
• DALFAMPRIDINEActive2013-10-15
• ILOPERIDONEActive2013-03-04
• MEMANTINE HYDROCHLORIDEActive2012-07-30
• CHLOPHEDIANOL HYDROCHLORIDEActive2009-06-25
• TROSPIUM CHLORIDEActive2008-10-08
• FELBAMATEActive2008-01-14
• PYRIDOSTIGMINE BROMIDEActive2002-06-26

Showing 15 of 40 Drug Master Files.

FDA compliance signals

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