EVONIK OPERATIONS GMBH
Overview
EVONIK OPERATIONS GMBH is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering AZELASTINE HYDROCHLORIDE; LISINOPRIL DIHYDRATE; LORAZEPAM.
API / Drug Master Files
EVONIK OPERATIONS GMBH holds 3 active (7 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.
- LISINOPRIL DIHYDRATEActive2006-01-26
- AZELASTINE HYDROCHLORIDEActive2001-05-15
- LORAZEPAMActive1983-07-09
- THIAPROLINE-M-AMINOBENZOIC ACID MONOHYDROCHLORIDEInactive2000-09-21
- NIFEDIPINEInactive1996-04-24
- CHLORHEXIDINE DIGLUCONATEInactive1990-01-19
- CHLORHEXIDINE BASEInactive1985-07-02
FDA compliance signals
No FDA recalls, Warning Letters, or Form 483 observations are linked to EVONIK OPERATIONS GMBH in our records. PharmaTek screens the full directory against live FDA enforcement data.
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