INKE SA

Overview

INKE SA is an active pharmaceutical ingredient (API) supplier with 24 active FDA Type II Drug Master Files, covering ACLIDINIUM BROMIDE; APREPITANT; ARFORMOTEROL TARTRATE (FORM A); ARFORMOTEROL TARTRATE (FORM D); CLEVIDIPINE BUTYRATE; FLUCONAZOLE.

API / Drug Master Files

INKE SA holds 24 active (26 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.

• INDACATEROL MALEATE (MICRONIZED AND NON-MICRONIZED)Active2024-06-25
• OLODATEROL HYDROCHLORIDEActive2023-07-21
• UMECLIDINIUM BROMIDEActive2023-06-16
• VILANTEROL TRIFENATATEActive2023-03-16
• ACLIDINIUM BROMIDEActive2023-03-16
• REVEFENACIN TRIHYDRATEActive2022-07-27
• TETRABENAZINEActive2022-06-21
• CLEVIDIPINE BUTYRATEActive2022-06-14
• ARFORMOTEROL TARTRATE (FORM A)Active2022-05-16
• APREPITANTActive2022-04-26
• TIOTROPIUM BROMIDE MONOHYDRATE (MICRONIZED AND NON-MICRONIZED)Active2020-03-17
• ARFORMOTEROL TARTRATE (FORM D)Active2018-07-25
• GLYCOPYRROLATEActive2017-07-22
• OLANZAPINEActive2013-01-24
• RIZATRIPTAN BENZOATEActive2011-12-22

Showing 15 of 26 Drug Master Files.

FDA compliance signals

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