LUNDBECK PHARMACEUTICALS ITALY SPA

Overview

LUNDBECK PHARMACEUTICALS ITALY SPA is an active pharmaceutical ingredient (API) supplier with 8 active FDA Type II Drug Master Files, covering ARGATROBAN; CLOMIPRAMINE HYDROCHLORIDE; DAPSONE; DESIPRAMINE HYDROCHLORIDE; DIAZOXIDE; IMIPRAMINE PAMOATE.

API / Drug Master Files

LUNDBECK PHARMACEUTICALS ITALY SPA holds 8 active (12 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.

• IMIPRAMINE PAMOATEActive2008-10-15
• ARGATROBANActive2008-01-30
• DAPSONEActive2000-09-29
• CLOMIPRAMINE HYDROCHLORIDEActive1990-11-19
• DIAZOXIDEActive1987-06-22
• TRIMIPRAMINE MALEATEActive1985-04-22
• METOCLOPRAMIDE HCL MONOHYDRATEActive1983-03-26
• DESIPRAMINE HYDROCHLORIDEActive1978-10-04
• ETHOTOINInactive2012-04-10
• MELPERONE HYDROCHLORIDEInactive2007-07-27
• ALFUZOSIN HYDROCHLORIDEInactive2007-05-15
• IMIPRAMINE HYDROCHLORIDEInactive1972-04-05

FDA compliance signals

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