AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPA

Overview

AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPA is an active pharmaceutical ingredient (API) supplier with 4 active FDA Type II Drug Master Files, covering AMANTADINE HYDROCHLORIDE; FLECAINIDE ACETATE; MELOXICAM; MEMANTINE HYDROCHLORIDE.

API / Drug Master Files

AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPA holds 4 active (6 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.

• AMANTADINE HYDROCHLORIDEActive2015-09-01
• MEMANTINE HYDROCHLORIDEActive2006-06-20
• MELOXICAMActive2004-03-16
• FLECAINIDE ACETATEActive2000-02-29
• FENOFIBRATEInactive2003-11-17
• ANAGRELIDE HYDROCHLORIDEInactive2003-11-12

FDA compliance signals

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