KONGO CHEMICAL CO LTD

Overview

KONGO CHEMICAL CO LTD is an active pharmaceutical ingredient (API) supplier with 7 active FDA Type II Drug Master Files, covering 2-HYDROXYMETHYL-4-(3-METHOXYPROPOXY)-3-METHYLPYRIDINE; BOC-PIPERAZINE (S)-3-[[(1,1-DIMETHYLETHYL) AMINO] CARBONYL] -1- PIPERAZINECARBOXYLIC ACID 1,1-DIMETHYLETHYL ESTER; CARBINOXAMINE MALEATE; CHLORPHENIRAMINE MALEATE USP; DEXCHLORPHENIRAMINE MALEATE; DIPHENHYDRAMINE HCL USP.

API / Drug Master Files

KONGO CHEMICAL CO LTD holds 7 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.

• 2-HYDROXYMETHYL-4-(3-METHOXYPROPOXY)-3-METHYLPYRIDINEActive1996-03-31
• BOC-PIPERAZINE (S)-3-[[(1,1-DIMETHYLETHYL) AMINO] CARBONYL] -1- PIPERAZINECARBOXYLIC ACID 1,1-DIMETHYLETHYL ESTERActive1995-10-31
• CARBINOXAMINE MALEATEActive1992-08-28
• PHENIRAMINE MALEATEActive1991-02-04
• DEXCHLORPHENIRAMINE MALEATEActive1982-10-16
• CHLORPHENIRAMINE MALEATE USPActive1980-07-14
• DIPHENHYDRAMINE HCL USPActive1980-07-14
• PAA-HC1 [4-PIPERIDYL ACETIC ACID-HCL]Inactive2001-10-01
• MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN OSAKA, JAPANInactive1998-09-30
• (3-N-ISOPROPYLAMINO-2-PIPERAZINYL) PYRIDINEInactive1996-03-29
• HYD [2-HYDROXYMETHYL-3-METHYL-4-(2,2,2-TRIFLUOROETHOXY PYRIDINE]Inactive1992-06-30
• D-BROMPHENIRAMINE MALEATEInactive1990-09-06
• PYRMETHYL ALCOHOLInactive1989-08-10
• L- CARNITINE HYDROCHLORIDEInactive1983-03-10
• FOLIC ACIDInactive1980-07-14

FDA compliance signals

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