FRESENIUS KABI ONCOLOGY LTD
Overview
FRESENIUS KABI ONCOLOGY LTD is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering BELINOSTAT.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances FRESENIUS KABI ONCOLOGY 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
FRESENIUS KABI ONCOLOGY LTD holds 1 active (28 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.
- BELINOSTATActive2018-01-05
- ROPIVACAINE HYDROCHLORIDE ANHYDROUSInactive2021-10-05
- RIBOCICLIB SUCCINATEInactive2020-09-10
- SUGAMMADEX SODIUMInactive2019-06-14
- ALECTINIB HYDROCHLORIDEInactive2019-06-12
- PLERIXAFORInactive2018-05-18
- IBRUTINIBInactive2017-05-12
- AFATINIB DIMALEATEInactive2016-12-31
- CARFILZOMIBInactive2016-01-30
- CHLORAMPHENICOL HEMISUCCINATEInactive2014-01-08
- BUPIVACAINE HYDROCHLORIDEInactive2012-12-28
- ROPIVACAINE HYDROCHLORIDEInactive2012-12-25
- BENDAMUSTINE HYDROCHLORIDEInactive2012-12-21
- TEMSIROLIMUSInactive2012-05-22
- DECITABINEInactive2011-12-16
Showing 15 of 28 Drug Master Files.
FDA compliance signals
30 FDA enforcement records linked to this company.
- 4832023-10-10
Procedures for sterile drug products
- 4832023-10-10
Scientifically sound laboratory controls
- 4832023-10-10
Validation lacking for sterile drug products
- 4832023-10-10
Procedures not in writing, fully followed
- 4832023-10-10
Following/documenting laboratory controls
- 4832023-10-10
Environmental Monitoring System
- 4832023-10-10
Prepared for each batch, include complete information
- 4832023-10-10
Written procedures not established/followed
- 4832023-10-10
Investigations of discrepancies, failures
- 4832023-10-10
Complete test data included in records
- 4832023-10-10
Cleaning System
- warning_letter2017-12-18
FDA Warning Letter (drug product)
- warning_letter2017-12-04
FDA Warning Letter (drug product)
- 4832015-05-22
SOPs not followed / documented
- 4832015-05-22
Procedures for sterile drug products
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