H. Lundbeck A/S
Overview
Lundbeck LLC is the U.S. subsidiary of H. Lundbeck A/S, a global pharmaceutical company specializing in brain diseases. The company focuses on developing innovative therapies for disorders such as depression, Alzheimer's disease, and Parkinson's disease.
Therapeutic areas
API / Drug Master Files
H. Lundbeck A/S holds 4 active (9 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.
- LU AA21004 HYDROBROMIDEActive2008-01-17
- GABOXADOL MONOHYDRATEActive2005-06-09
- ESCITALOPRAM OXALATEActive1999-04-29
- CITALOPRAM HYDROBROMIDEActive1997-02-24
- LU AA24530 HYDROBROMIDEInactive2008-09-29
- MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN LAMSAS, DENMARKInactive1997-02-24
- MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN SEAL SANDS, UNITED KINGDOMInactive1997-02-24
- MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN VALBY, DENMARKInactive1997-02-24
- LU-25-109-M DRUG SUBSTANCEInactive1996-12-09
FDA compliance signals
2 FDA enforcement records linked to this company.
- 4832018-04-27
Quality control unit review of records
- 4832018-04-27
Procedures not in writing, fully followed
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