SYNBIAS PHARMA AG

Overview

SYNBIAS PHARMA AG is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering DOXORUBICIN HYDROCHLORIDE; EPIRUBICIN HYDROCHLORIDE; IDARUBICIN HCL; NELARABINE; VALRUBICIN USP.

API / Drug Master Files

SYNBIAS PHARMA AG holds 5 active (10 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.

• IDARUBICIN HCLActive2021-12-02
• NELARABINEActive2016-05-25
• VALRUBICIN USPActive2013-02-26
• EPIRUBICIN HYDROCHLORIDEActive2002-10-31
• DOXORUBICIN HYDROCHLORIDEActive2002-10-09
• CLOFARABINEInactive2015-05-11
• VINORELBINE TARTRATEInactive2014-05-06
• TOPOTECAN HYDROCHLORIDEInactive2010-03-29
• VINORELBINE TARTRATEInactive2008-09-01
• IDARUBICIN HYDROCHLORIDEInactive2004-06-26

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to SYNBIAS PHARMA AG in our records. PharmaTek screens the full directory against live FDA enforcement data.