MERCK SANTE SAS

Overview

MERCK SANTE SAS is an active pharmaceutical ingredient (API) supplier with 4 active FDA Type II Drug Master Files, covering GLUCOPHAGE 850 MG, FILM-COATED TABLETS; GLUCOPHAGE XR 500 MG, PROLONGED RELEASE TABLETS – BULK (REDUCED MASS); METFORMIN HYDROCHLORIDE; METFORMIN HYDROCHLORIDE DRUG SUBTANCE.

API / Drug Master Files

MERCK SANTE SAS holds 4 active (7 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.

• GLUCOPHAGE XR 500 MG, PROLONGED RELEASE TABLETS – BULK (REDUCED MASS)Active2019-12-13
• GLUCOPHAGE 850 MG, FILM-COATED TABLETSActive2019-02-19
• METFORMIN HYDROCHLORIDE DRUG SUBTANCEActive1997-09-30
• METFORMIN HYDROCHLORIDEActive1985-08-09
• CRE 16257 DRUG SUBSTANCEInactive2002-10-11
• CRE 15876/A4 INTERMEDIATEInactive2002-10-11
• CALCIUM ACAMPROSATE NEW DRUG SUBSTANCEInactive1996-06-10

FDA compliance signals

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