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

Active ingredients with DMF or CEP filings

Substances for which MEDICHEM MANUFACTURING (MALTA) LTD holds, or has held, a US FDA Drug Master File or an EU CEP. A filing is not proof of current supply. Open any ingredient to see all its holders, CAS number and product patent dates.

API / Drug Master Files

MEDICHEM MANUFACTURING (MALTA) LTD holds 13 active (23 total) FDA Type II Drug Master Files. A Type II DMF is filed with the FDA to support an active ingredient in drug applications; an active filing can be referenced but is not proof of current supply, and inactive filings are historical.

• 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
• SAXAGLIPTIN HYDROCHLORIDE DIHYDRATEInactive2013-04-29
• MED-200850/M (LACOSAMIDE)Inactive2012-09-05
• RASAGILINE MESYLATE(MED-201593/M)Inactive2010-04-07
• DARIFENACIN HYDROBROMIDE(MED-200380/M)Inactive2008-10-24
• MED-201570/MInactive2008-08-01
• MED-200448/MInactive2008-07-29
• MED-201100/MInactive2008-03-13
• ZALEPLON (MED - 201970)Inactive2006-05-24

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to MEDICHEM MANUFACTURING (MALTA) LTD in our records. Events are linked by company name and identifier, so this is not proof that none exist; check the FDA's own databases before relying on it.