Bristol-Myers Squibb Company
Overview
Bristol-Myers Squibb Company is a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. After acquiring Celgene Corporation in 2019, the company has expanded its portfolio in oncology, hematology, immunology, and cardiovascular disease.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Bristol-Myers Squibb Company 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
Bristol-Myers Squibb Company holds 1 active (41 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.
- MDX-010 (ANTI-CTLA4 HUMAN MONOCLONAL ANTIBODY)Active2005-08-23
- MDX-1100 (ANTI-CXCL 10/ANTI-IP-10 HUMAN MONOCLONAL ANTIBODY)Inactive2005-04-04
- GARENOXACIN MESYLATE (BMS-284756-01) DRUG SUBSTANCEInactive2003-04-22
- HUMAN MONOCLONAL ANTIBODY (MDX-060) TO CD30Inactive2002-04-17
- ARIPIPRAZOLE TABLETSInactive2001-10-05
- AMPHOTERICIN NON PARENTAL GRADEInactive1999-07-08
- IRBESARTANInactive1998-10-08
- METHICILLIN SODIUMInactive1998-09-01
- HETACILLIN POTASSIUMInactive1998-09-01
- DICLOXACILLIN SODIUMInactive1998-09-01
- OXACILLIN SODIUMInactive1998-09-01
- CLOXACILLIN SODIUMInactive1998-09-01
- AMPICILLIN TRIHYDRATEInactive1998-09-01
- NYSTATINInactive1998-09-01
- AMIKACIN BASEInactive1998-09-01
Showing 15 of 41 Drug Master Files.
FDA compliance signals
9 FDA enforcement records linked to this company.
- recall — Class II2025-10-29
Lack of Assurance of Sterility.
- 4832019-03-07
Failure to submit scientific article
- recall — Class I2017-07-19
Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg tablets.
- 4832016-04-27
Failure to submit scientific article
- 4832013-05-02
Late submission of quarterly safety reports
- 4832013-05-02
Late submission of annual safety reports
- recall — Class II2012-10-31
Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.
- recall — Class II2012-10-31
Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.
- recall — Class I2012-10-31
Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being recalled because of an overfilled vial discovered during stability testing for a single carmustine lot.
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