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.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances AMSA SPA is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
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.
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