Celgene Corporation
Overview
Celgene Corporation, acquired by Bristol Myers Squibb in 2019, is a leading biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for unmet medical needs. Celgene specializes in treatments for cancer and inflammatory disorders.
Therapeutic areas
API / Drug Master Files
Celgene Corporation holds 0 active (2 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.
- MARIZOMIB, A LYOPHILIZED POWDER FOR INJECTION WITH ACCOMPANYING DILUENTInactive2018-05-04
- FR901228Inactive1996-08-07
FDA compliance signals
11 FDA enforcement records linked to this company.
- 4832024-12-06
Failure to comply with REMS Elements to Assure Safe Use (ETASU) E
- 4832024-12-06
Failure to comply with REMS Implementation System
- 4832024-12-06
Failure to comply with REMS Elements to Assure Safe Use (ETASU) B
- 4832024-12-06
Failure to comply with REMS Elements to Assure Safe Use (ETASU) A
- 4832023-06-16
Mfg / Processing Operations Area
- 4832023-06-16
Expiration date lacking
- 4832023-06-16
Absence of Written Procedures
- 4832023-06-16
Environmental Monitoring System
- 4832013-04-24
Failure to develop written procedures
- 4832013-04-24
Post marketing study status report for other studies
- 4832013-04-24
Late submission of 15-day report
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