Eisai Co., Ltd.
Overview
Eisai Co., Ltd. is a leading global pharmaceutical company headquartered in Japan. It is focused on the research, development, and distribution of innovative treatments for various therapeutic areas. The company is well-known for its work in neurology and oncology.
Therapeutic areas
API / Drug Master Files
Eisai Co., Ltd. holds 1 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.
- MOH040Active2019-03-27
- INTERLEUKIN-2 DIPHTHERIA TOXIN FUSION PROTEIN (DAB 389 IL-2)Inactive1992-08-14
- EPERISONEInactive1989-04-04
- MENFEGOLInactive1985-06-28
- BENTIROMIDEInactive1984-05-31
FDA compliance signals
26 FDA enforcement records linked to this company.
- 4832023-10-27
Storage under appropriate conditions
- 4832023-10-27
Procedures not in writing, fully followed
- 4832018-12-21
Establishment of time limitations
- 4832018-12-21
Calibration/Inspection/Checking not done
- 4832018-12-21
Records not made readily available to FDA
- 4832018-12-21
Cleaning / Sanitizing / Maintenance
- 4832018-12-21
Following/documenting laboratory controls
- 4832018-12-21
Written procedures fail to include
- 4832018-12-21
Training , Education , Experience overall
- 4832016-07-22
Computer control of master formula records
- 4832016-07-22
Following/documenting laboratory controls
- 4832016-07-22
Complete test data included in records
- 4832016-07-22
Rejected in-process materials not quarantined
- 4832016-07-22
Extent of discrepancy, failure investigations
- 4832015-12-10
Procedures not in writing, fully followed
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