WOCKHARDT BIO AG

Overview

WOCKHARDT BIO AG is an active pharmaceutical ingredient (API) supplier with 8 active FDA Type II Drug Master Files, covering ARIPIPRAZOLE; FESOTERODINE FUMARATE; FOSAPREPITANT DIMEGLUMINE; PALIPERIDONE USP; PALONOSETRON HYDROCHLORIDE USP; REGADENOSON (AMORPHOUS).

API / Drug Master Files

WOCKHARDT BIO AG holds 8 active (10 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.

• PALONOSETRON HYDROCHLORIDE USPActive2016-10-19
• FOSAPREPITANT DIMEGLUMINEActive2015-12-31
• REGADENOSON (AMORPHOUS)Active2015-03-31
• PALIPERIDONE USPActive2014-10-07
• SAXAGLIPTIN HYDROCHLORIDEActive2013-07-17
• SITAGLIPTIN PHOSPHATEActive2013-05-27
• ARIPIPRAZOLEActive2013-02-26
• FESOTERODINE FUMARATEActive2012-10-24
• CLARITHROMYCIN USPInactive2004-07-14
• OXYBUTYNIN CHLORIDE USPInactive2002-07-22

FDA compliance signals

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