MINAKEM

Overview

MINAKEM is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering BUDESONIDE MICRONIZED; ESOMEPRAZOLE MAGNESIUM DIHYDRATE MICRONIZED AND NON MICRONIZED; ESOMEPRAZOLE MAGNESIUM TRIHYDRATE.

API / Drug Master Files

MINAKEM holds 3 active (3 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.

• ESOMEPRAZOLE MAGNESIUM DIHYDRATE MICRONIZED AND NON MICRONIZEDActive2019-10-04
• ESOMEPRAZOLE MAGNESIUM TRIHYDRATEActive2014-07-08
• BUDESONIDE MICRONIZEDActive2014-06-20

FDA compliance signals

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