FARMAK AS

Overview

FARMAK AS is an active pharmaceutical ingredient (API) supplier with 7 active FDA Type II Drug Master Files, covering BRIMONIDINE TARTRATE; BROENAC SODIUM; DOFETILIDE; REGADENOSON; TIZANIDINE HCL; WARFARIN SODIUM.

API / Drug Master Files

FARMAK AS holds 7 active (18 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.

• BROENAC SODIUMActive2023-10-18
• REGADENOSONActive2021-01-04
• DOFETILIDEActive2017-07-24
• WARFARIN SODIUMActive2008-11-11
• BRIMONIDINE TARTRATEActive2001-08-15
• TIZANIDINE HCLActive2001-07-04
• ZOLPIDEM TARTRATEActive2001-06-21
• TAFAMIDIS MEGLUMINE (NON-MICRONIZED)Inactive2023-09-26
• ZILEUTON USPInactive2017-09-19
• SELEGILINE HYDROCHLORIDE USPInactive2016-10-06
• ZILEUTONInactive2013-10-30
• REGADENOSON MONOHYDRATEInactive2012-04-02
• ZOPICLONEInactive2008-12-24
• ESZOPICLONEInactive2008-03-07
• QUETIAPINE FUMARATEInactive2007-09-17

Showing 15 of 18 Drug Master Files.

FDA compliance signals

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