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.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances EVONIK OPERATIONS 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
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
4 FDA enforcement records linked to this company.
- 4832014-12-12
Computer control of master formula records
- 4832014-12-12
Procedures not in writing, fully followed
- 4832014-12-12
Calibration - at intervals, written program, remedial action
- 4832014-12-12
Lab controls established, including changes
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