MEDICHEM MANUFACTURING (MALTA) LTD

Overview

MEDICHEM MANUFACTURING (MALTA) LTD is an active pharmaceutical ingredient (API) supplier with 13 active FDA Type II Drug Master Files, covering AMBRISENTAN (MED-200028/M); APIXABAN; CINACALCET HYDROCHLORIDE (MED-200140/M ); EDARAVONE; LOFEXIDINE HYDROCHLORIDE; MED-200400/M (Desvenlafaxine Succinate).

Core services & business areas

API / Drug Master Files

MEDICHEM MANUFACTURING (MALTA) LTD holds 13 active (23 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.

• LOFEXIDINE HYDROCHLORIDEActive2023-07-17
• PRUCALOPRIDE SUCCINATEActive2022-06-13
• REVEFENACINActive2022-04-19
• EDARAVONEActive2020-10-26
• SUGAMMADEX SODIUMActive2019-06-17
• APIXABANActive2016-06-30
• MICAFUNGIN SODIUMActive2016-06-06
• SUNITINIB MALATEActive2016-06-03
• RIVAROXABANActive2014-12-23
• AMBRISENTAN (MED-200028/M)Active2014-11-18
• MED-200400/M (Desvenlafaxine Succinate)Active2011-12-22
• MED-201950/E (VORICONAZOLE)Active2008-03-18
• CINACALCET HYDROCHLORIDE (MED-200140/M )Active2008-03-06
• BEPOTASTINE BESILATEInactive2014-12-10
• BEPOTASTINE BESILATEInactive2013-07-03

Showing 15 of 23 Drug Master Files.

FDA compliance signals

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