ABX ADVANCED BIOCHEMICAL COMPOUNDS BIOMEDIZINISCHE FORSCHUNGSREAGENZIEN GMBH

Overview

ABX ADVANCED BIOCHEMICAL COMPOUNDS BIOMEDIZINISCHE FORSCHUNGSREAGENZIEN GMBH is an active pharmaceutical ingredient (API) supplier with 11 active FDA Type II Drug Master Files, covering [18O] WATER; BETIATIDE; DIBROMOMETHANE; DIMETHYLAMINOETHANOL; DOTA-TATE ACETATE; DOTA-TOC ACETATE.

API / Drug Master Files

ABX ADVANCED BIOCHEMICAL COMPOUNDS BIOMEDIZINISCHE FORSCHUNGSREAGENZIEN GMBH holds 11 active (15 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.

• [18O] WATERActive2024-09-16
• DOTA-TOC ACETATEActive2022-02-28
• TBSCT-FPActive2020-11-25
• DIMETHYLAMINOETHANOLActive2020-11-17
• DIBROMOMETHANEActive2020-11-17
• PSMA-11Active2019-04-30
• DOTA-TATE ACETATEActive2019-04-30
• TETRAKIS (2-METHOXY-ISOBUTYL ISONITRILE) COPPER (I) TETRAFLUOROBORATEActive2015-12-11
• BETIATIDEActive2013-12-20
• EXAMETAZIMEActive2013-09-09
• MIBG DRUG SUBSTANCEActive2008-04-18
• Ethanol Ph. Eur.Inactive2022-03-22
• REAGENT KIT FOR SYNTHESIS OF 68GA PEPTIDES USING CATIONIC PURIFICATIONInactive2022-03-04
• CASSETTE FOR SYNTHESIS OF 68 GA PEPTIDESInactive2022-03-04
• REAGENT AND HARDWARE KIT FOR SYNTHESIS OF 68GA PEPTIDES USING CATIONIC PURIFICATIONInactive2017-03-13

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to ABX ADVANCED BIOCHEMICAL COMPOUNDS BIOMEDIZINISCHE FORSCHUNGSREAGENZIEN GMBH in our records. PharmaTek screens the full directory against live FDA enforcement data.