ZHUHAI RUNDU PHARMACEUTICAL CO LTD

Overview

ZHUHAI RUNDU PHARMACEUTICAL CO LTD is an active pharmaceutical ingredient (API) supplier with 10 active FDA Type II Drug Master Files, covering CANDESARTAN CILEXETIL NON-STERILE BULK DRUG SUBSTANCE; HYDROXYCHLOROQUINE SULFATE; IRBESARTAN, NON-STERILE BULK DRUG SUBSTANCE; OLMESARTAN MEDOXOMIL; SACUBITRIL CARBOXYL COMPOUND NON-STERILE BULK DRUG SUBSTANCE INTERMEDIATE; SACUBITRIL SODIUM.

API / Drug Master Files

ZHUHAI RUNDU PHARMACEUTICAL CO LTD holds 10 active (12 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.

• SACUBITRIL CARBOXYL COMPOUND NON-STERILE BULK DRUG SUBSTANCE INTERMEDIATEActive2023-12-29
• VORICONAZOLE NON-STERILE BULK DRUG SUBSTANCEActive2023-01-16
• CANDESARTAN CILEXETIL NON-STERILE BULK DRUG SUBSTANCEActive2022-11-04
• HYDROXYCHLOROQUINE SULFATEActive2022-01-26
• SACUBITRIL/VALSARTANActive2021-04-28
• OLMESARTAN MEDOXOMILActive2020-12-23
• IRBESARTAN, NON-STERILE BULK DRUG SUBSTANCEActive2019-11-12
• VALSARTAN DISODIUMActive2019-01-28
• SACUBITRIL SODIUMActive2019-01-23
• VALSARTANActive2017-12-13
• IRBESARTANInactive2011-11-14
• VALSARTANInactive2011-11-14

FDA compliance signals

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