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.

Therapeutic areas

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

No FDA recalls, Warning Letters, or Form 483 observations are linked to FRESENIUS KABI ONCOLOGY LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.