AMSA SPA

Overview

AMSA SPA is an active pharmaceutical ingredient (API) supplier with 6 active FDA Type II Drug Master Files, covering DICLOFENAC HYDROXY ETHYL PYRROLIDINE; ETODOLAC; GLIPIZIDE; GLYCOPYRROLATE; LURASIDONE HYDROCHLORIDE; VILOXAZINE HYDROCHLORIDE.

API / Drug Master Files

AMSA SPA holds 6 active (8 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.

• VILOXAZINE HYDROCHLORIDEActive2024-05-29
• LURASIDONE HYDROCHLORIDEActive2014-04-30
• GLYCOPYRROLATEActive2003-11-13
• DICLOFENAC HYDROXY ETHYL PYRROLIDINEActive2000-04-10
• GLIPIZIDEActive1998-07-30
• ETODOLACActive1995-02-20
• TOLMETIN SODIUMInactive2003-02-17
• CARTEOLOL HYDROCHLORIDEInactive2000-07-03

FDA compliance signals

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