TOPHARMAN SHANDONG CO LTD

Overview

TOPHARMAN SHANDONG CO LTD is an active pharmaceutical ingredient (API) supplier with 10 active FDA Type II Drug Master Files, covering 1-((2R,3R,4R,5R)-3-FLUORO-4-HYDROXY-5-(HYDROXYMETHYL)-3-METHYLTETRAHYDROFURAN-2-YL) PYRIMIDINE-2,4(1H,3H)-DIONE (SOFOSBUVIR INTERMEDIATE); ARIPIPRAZOLE; BREXPIPRAZOLE; DAPOXETINE HYDROCHLORIDE; EFINACONAZOLE; NERATINIB MALEATE.

API / Drug Master Files

TOPHARMAN SHANDONG CO LTD holds 10 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.

• TECOVIRIMATActive2024-01-04
• DAPOXETINE HYDROCHLORIDEActive2022-10-26
• NERATINIB MALEATEActive2022-08-29
• BREXPIPRAZOLEActive2022-06-15
• RIVAROXABANActive2021-02-04
• TADALAFILActive2018-08-10
• EFINACONAZOLEActive2018-02-02
• 1-((2R,3R,4R,5R)-3-FLUORO-4-HYDROXY-5-(HYDROXYMETHYL)-3-METHYLTETRAHYDROFURAN-2-YL) PYRIMIDINE-2,4(1H,3H)-DIONE (SOFOSBUVIR INTERMEDIATE)Active2015-08-31
• ARIPIPRAZOLEActive2014-09-16
• TELMISARTANActive2014-05-22

FDA compliance signals

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