LABORCHEMIE APOLDA GMBH

Overview

LABORCHEMIE APOLDA GMBH is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering BENDAMUSTINE HYDROCHLORIDE; D-PENICILLAMINE (NEEDLES); D-PENICILLAMINE HYDROCHLORIDE; DIENOGEST; MENGLYTATE.

API / Drug Master Files

LABORCHEMIE APOLDA GMBH holds 5 active (5 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.

• D-PENICILLAMINE (NEEDLES)Active2014-06-27
• BENDAMUSTINE HYDROCHLORIDEActive2014-02-24
• MENGLYTATEActive2013-01-18
• D-PENICILLAMINE HYDROCHLORIDEActive2012-11-15
• DIENOGESTActive2011-08-14

FDA compliance signals

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