COSMA SPA

Overview

COSMA SPA is an active pharmaceutical ingredient (API) supplier with 17 active FDA Type II Drug Master Files, covering AMISULPRIDE; CETIRIZINE DIHYDROCHLORIDE; DICLOFENAC HYDROXY ETHYL PYRROLIDINE; GLICLAZIDE; HYDROXYZINE HYDROCHLORIDE; HYDROXYZINE PAMOATE.

API / Drug Master Files

COSMA SPA holds 17 active (29 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.

• AMISULPRIDEActive2019-06-11
• LEVOMILNACIPRAN HYDROCHLORIDEActive2017-03-16
• DICLOFENAC HYDROXY ETHYL PYRROLIDINEActive2014-03-04
• MILNACIPRAN HYDROCHLORIDEActive2012-02-23
• GLICLAZIDEActive2011-12-06
• RANOLAZINEActive2009-06-15
• CETIRIZINE DIHYDROCHLORIDEActive2007-02-21
• TORSEMIDE 1016Active2001-07-31
• TORSEMIDE 1024Active2001-07-31
• LABETALOL HYDROCHLORIDEActive2000-02-04
• OXAPROZINActive1998-05-21
• PYRANTEL PAMOATEActive1988-09-09
• KETOPROFENActive1988-07-21
• METOCLOPRAMIDE HYDROCHLORIDEActive1982-05-03
• HYDROXYZINE PAMOATEActive1982-04-16

Showing 15 of 29 Drug Master Files.

FDA compliance signals

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