CHEMISCHE FABRIK BERG GMBH

Overview

CHEMISCHE FABRIK BERG GMBH is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering BUTALBITAL; HYDROXYZINE HYDROCHLORIDE; METHENAMINE HIPPURATE; PHENTERMINE HYDROCHLORIDE USP; PROPYLTHIOURACIL USP.

API / Drug Master Files

CHEMISCHE FABRIK BERG GMBH holds 5 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.

• HYDROXYZINE HYDROCHLORIDEActive2023-12-05
• METHENAMINE HIPPURATEActive2014-04-04
• PROPYLTHIOURACIL USPActive2003-05-07
• PHENTERMINE HYDROCHLORIDE USPActive2001-05-14
• BUTALBITALActive1981-11-25
• PHENOBARBITAL USPInactive2009-12-14
• PENTOBARBITAL SODIUM USPInactive2006-03-14
• BUTALBITAL USPInactive2001-10-01
• BUTABARBITAL SODIUMInactive2000-03-03
• METHENAMINE HIPPURATEInactive1988-06-08

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to CHEMISCHE FABRIK BERG GMBH in our records. PharmaTek screens the full directory against live FDA enforcement data.