ITF CHEMICAL LTDA

Overview

ITF CHEMICAL LTDA is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering AZACYTIDINE; DECITABINE; LEVOFLOXACIN HEMIHYDRATE; ROSIGLITAZONE MALEATE; TEMOZOLOMIDE, USP.

API / Drug Master Files

ITF CHEMICAL LTDA holds 5 active (13 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.

• AZACYTIDINEActive2014-03-18
• DECITABINEActive2012-12-11
• TEMOZOLOMIDE, USPActive2012-10-10
• ROSIGLITAZONE MALEATEActive2006-11-23
• LEVOFLOXACIN HEMIHYDRATEActive2004-07-30
• PEMETREXED DISODIUM EPInactive2015-06-09
• BENDAMUSTINE HYDROCHLORIDEInactive2014-07-29
• MOXIFLOXACIN HYDROCHLORIDEInactive2009-11-27
• SODIUM RISEDRONATE AMORPHOUSInactive2007-12-21
• TOLTERODINE L-TARTRATEInactive2006-06-07
• LANSOPRAZOLEInactive2005-03-22
• AZITHROMYCIN MONOHYDRATEInactive2005-02-28
• PAROXETINE HYDROCHLORIDE HEMIHYDRATEInactive2002-11-19

FDA compliance signals

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