BAXTER HEALTHCARE CORP
Overview
BAXTER HEALTHCARE CORP is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering CYCLOPHOSPHAMIDE, USP/EP; IFOSFAMIDE USP/EP; MESNA, USP/EP DRUG SUBSTANCE.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances BAXTER HEALTHCARE CORP 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
BAXTER HEALTHCARE CORP holds 3 active (6 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.
- MESNA, USP/EP DRUG SUBSTANCEActive2011-09-08
- CYCLOPHOSPHAMIDE, USP/EPActive1979-06-11
- IFOSFAMIDE USP/EPActive1979-04-24
- MURINE MONOCLONAL ANTIBODIES (ANTI-CD8/CD4) TO HUMAN T-CELLSInactive2005-08-23
- ANTI-PROTEIN C AFFINITY MATRIXInactive1990-12-21
- FACILITIES IN MORTON GROVE, IL AND BRIDGEPORT, NJInactive1988-07-12
FDA compliance signals
50 FDA enforcement records linked to this company.
- 4832026-04-02
Equipment Design, Size and Location
- 4832026-04-02
Defined areas of adequate size for operations
- 4832026-04-02
Acceptance/Rejection Levels
- 4832026-04-02
Written procedures not established/followed
- 4832026-04-02
Training--operations, GMPs, written procedures
- 4832026-04-02
Procedure Deviations Recorded and Justified
- 4832026-04-02
Investigations of discrepancies, failures
- 4832026-04-02
Validation lacking for sterile drug products
- 4832026-04-02
Following/documenting laboratory controls
- recall — Class II2026-02-04
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
- 4832025-09-29
Cleaning / Sanitizing / Maintenance
- 4832025-09-29
Scientifically sound laboratory controls
- 4832025-09-29
Buildings not maintained in good state of repair
- 4832025-09-29
Backup data not assured as exact and complete
- 4832025-09-29
Investigations of discrepancies, failures
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