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.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Eisai Co., Ltd. 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
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
Training , Education , Experience overall
- 4832018-12-21
Written procedures fail to include
- 4832018-12-21
Calibration/Inspection/Checking not done
- 4832018-12-21
Records not made readily available to FDA
- 4832018-12-21
Following/documenting laboratory controls
- 4832018-12-21
Cleaning / Sanitizing / Maintenance
- 4832018-12-21
Establishment of time limitations
- 4832016-07-22
Complete test data included in records
- 4832016-07-22
Computer control of master formula records
- 4832016-07-22
Following/documenting laboratory controls
- 4832016-07-22
Rejected in-process materials not quarantined
- 4832016-07-22
Extent of discrepancy, failure investigations
- 4832015-12-10
Written warehousing procedures established/followed
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