MOREPEN LABORATORIES LTD

Overview

MOREPEN LABORATORIES LTD is an active pharmaceutical ingredient (API) supplier with 31 active FDA Type II Drug Master Files, covering APIXABAN; APIXABAN AMORPHOUS; APIXABAN FORM H3; ATORVASTATIN CALCIUM TRIHYDRATE; BEMPEDOIC ACID; BREXPIPRAZOLE.

API / Drug Master Files

MOREPEN LABORATORIES LTD holds 31 active (34 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.

• BEMPEDOIC ACIDActive2025-12-12
• RUPATADINE FUMARATEActive2025-11-22
• VORTIOXETINE HYDROBROMIDE (ROUTE-II)Active2025-09-05
• BREXPIPRAZOLEActive2024-12-02
• TICAGRELORActive2024-08-27
• VONOPRAZAN FUMARATEActive2023-01-05
• ERTUGLIFLOZIN L-PYROGLUTAMATEActive2022-07-26
• DAPAGLIFLOZIN AMORPHOUSActive2022-03-14
• VORTIOXETINE HYDROBROMIDEActive2022-01-31
• APIXABAN AMORPHOUSActive2021-12-27
• OLMESARTAN MEDOXOMILActive2021-12-02
• RIVAROXABANActive2021-08-28
• LINAGLIPTIN FORM CActive2021-08-18
• EDOXABAN TOSYLATEActive2021-07-02
• APIXABAN FORM H3Active2021-05-03

Showing 15 of 34 Drug Master Files.

FDA compliance signals

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