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.

Core services & business areas

API ManufacturingPharmaceutical Manufacturing

Active pharmaceutical ingredients supplied

Substances LABORCHEMIE APOLDA GMBH is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

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.

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