CHEMI SPA

Overview

CHEMI SPA is an active pharmaceutical ingredient (API) supplier with 10 active FDA Type II Drug Master Files, covering AICA HYDROCHLORIDE; BUPROPION HCL FV3307; BUPROPION HYDROCHLORIDE; CHE001-05 (BUPROPIONE HYDROBROMIDE); DIFLUNISAL; GIVINOSTAT HYDROCHLORIDE MONOHYDRATE.

API / Drug Master Files

CHEMI SPA holds 10 active (40 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.

• GIVINOSTAT HYDROCHLORIDE MONOHYDRATEActive2023-04-04
• MESALAMINE CRYSTALLIZED, USPActive2011-10-13
• BUPROPION HCL FV3307Active2009-10-19
• OCTREOTIDE ACETATEActive2006-06-28
• CHE001-05 (BUPROPIONE HYDROBROMIDE)Active2005-10-27
• LEUPROLIDE ACETATEActive2000-03-07
• AICA HYDROCHLORIDEActive1999-03-05
• MESALAMINE USPActive1996-04-29
• BUPROPION HYDROCHLORIDEActive1996-01-29
• DIFLUNISALActive1988-05-22
• FESOTERODINE FUMARATEInactive2012-09-28
• ZOLEDRONIC ACID HEMIPENTAHYDRATEInactive2012-04-19
• EPTIFIBATIDEInactive2011-05-11
• DAPC (1,2-DIARACHIDOYL-SN-GLYCERO-3-PHOSPHOCHOLINE)Inactive2008-02-20
• SODIUM IBANDRONATE MONOHYDRATEInactive2007-04-05

Showing 15 of 40 Drug Master Files.

FDA compliance signals

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