ARCHIMICA SPA

Overview

ARCHIMICA SPA is an active pharmaceutical ingredient (API) supplier with 12 active FDA Type II Drug Master Files, covering BROENAC SODIUM; CAPECITABINE; CYTARABINE; DIACEREIN (PROCESS I); DISOPYRAMIDE PHOSPHATE; HYDRALAZINE HYDROCHLORIDE.

API / Drug Master Files

ARCHIMICA SPA holds 12 active (25 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.

• PIRENZEPINE BASE PUREActive2019-06-06
• CAPECITABINEActive2011-09-07
• CYTARABINEActive2011-09-07
• DIACEREIN (PROCESS I)Active2010-07-13
• BROENAC SODIUMActive2010-04-12
• HYDRALAZINE HYDROCHLORIDEActive2008-10-31
• OXCARBAZEPINEActive2003-05-15
• SUCRALFATEActive2003-05-13
• DISOPYRAMIDE PHOSPHATEActive1999-06-11
• PIRENZEPINE DIHYDROCHLORIDEActive1998-11-05
• HYDROXYUREAActive1997-11-14
• SULFAPYRIDINEActive1986-10-29
• AMRINONE, USPInactive1998-09-22
• SANCYCLINEInactive1996-01-26
• OP 3300/15Inactive1995-11-28

Showing 15 of 25 Drug Master Files.

FDA compliance signals

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