BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG

Overview

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering ALBUTEROL SULFATE (UNMICRONIZED); EPINASTINE HYDROCHLORIDE; IPRATROPIUM BROMIDE MONOHYDRATE; PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE; REPAGLINIDE.

API / Drug Master Files

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG holds 5 active (34 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.

• PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATEActive2008-03-12
• REPAGLINIDEActive2006-07-24
• EPINASTINE HYDROCHLORIDEActive2000-09-11
• ALBUTEROL SULFATE (UNMICRONIZED)Active1999-06-25
• IPRATROPIUM BROMIDE MONOHYDRATEActive1999-06-25
• PHENYLEPHRINE HYDROCHLORIDE 150 MESHInactive2009-08-03
• TIOTROPIUM BROMIDE MONOHYDRATEInactive2008-09-05
• DIGOXIN 20 MICROMETERInactive2008-04-15
• SCOPOLAMINE (HYOSCINE)Inactive2006-09-14
• METHSCOPOLAMINE NITRATEInactive2005-04-20
• TIOTROPIUM BROMIDE MONOHYDRATEInactive2005-03-03
• METHSCOPOLAMINE BROMIDEInactive2005-02-08
• ZOLPIDEM TARTRATEInactive2003-10-31
• IFN-OMEGAInactive2003-04-07
• TROSPIUM CHLORIDEInactive2000-07-20

Showing 15 of 34 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG in our records. PharmaTek screens the full directory against live FDA enforcement data.