FUJIAN KERUI PHARMACEUTICAL CO LTD

Overview

FUJIAN KERUI PHARMACEUTICAL CO LTD is an active pharmaceutical ingredient (API) supplier with 8 active FDA Type II Drug Master Files, covering ACETYLCYSTEINE; CYCLOSPORINE; CYTARABINE; DOCETAXEL ANHYDROUS, NON-STERILE, BULK DRUG SUBSTANCE; FLUOROURACIL; PACLITAXEL (SEMI-SYNTHETIC) USP NON STERILE BULK DRUG SUBSTANCE.

API / Drug Master Files

FUJIAN KERUI PHARMACEUTICAL CO LTD holds 8 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.

• CYTARABINEActive2025-04-23
• FLUOROURACILActive2024-12-11
• ACETYLCYSTEINEActive2023-06-26
• PACLITAXEL (SEMI-SYNTHETIC) USP NON STERILE BULK DRUG SUBSTANCEActive2012-02-23
• DOCETAXEL ANHYDROUS, NON-STERILE, BULK DRUG SUBSTANCEActive2011-09-07
• TACROLIMUS, NON-STERILE, BULK DRUG SUBSTANCEActive2008-07-16
• SIROLIMUSActive2003-10-01
• CYCLOSPORINEActive1998-09-01
• 10-DEACETYL-BACCATIN III (10-DAB III) (NON-STERILE)Inactive2011-09-07
• PACLITAXEL (NATURAL) USP (NATURAL, NON-STERILE BULK DRUG SUBSTANCE)Inactive2010-02-19

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to FUJIAN KERUI PHARMACEUTICAL CO LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.