WATERSTONE PHARMACEUTICALS (HUBEI) CO LTD

Overview

WATERSTONE PHARMACEUTICALS (HUBEI) CO LTD is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering COLESEVELAM HYDROCHLORIDE; DEFERASIROX; MONOMETHYL AURISTATIN E (MMAE); PAYLOAD-LINKER VCMMAE; SEVELAMER CARBONATE.

API / Drug Master Files

WATERSTONE PHARMACEUTICALS (HUBEI) CO LTD holds 5 active (13 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.

• PAYLOAD-LINKER VCMMAEActive2025-04-21
• DEFERASIROXActive2025-04-01
• MONOMETHYL AURISTATIN E (MMAE)Active2024-07-31
• COLESEVELAM HYDROCHLORIDEActive2022-12-22
• SEVELAMER CARBONATEActive2022-08-07
• DEXLANSOPRAZOLEInactive2015-05-19
• EZETIMIBEInactive2014-12-04
• DEFERASIROXInactive2014-10-15
• LANSOPRAZOLEInactive2014-05-20
• CELECOXIBInactive2013-12-04
• L-Ala-pAF-OH HClInactive2013-08-25
• FEBUXOSTATInactive2012-09-25
• LEVETIRACETAMInactive2012-06-25

FDA compliance signals

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