YUKI GOSEI KOGYO CO LTD

Overview

YUKI GOSEI KOGYO CO LTD is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering AMINOACETIC ACID; ISONIAZID BULK FORM; PROTAMINE SULFATE; TRIFLUOROTHYMIDINE; TRIFLURIDINE.

API / Drug Master Files

YUKI GOSEI KOGYO CO LTD holds 5 active (17 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.

• TRIFLURIDINEActive2014-11-20
• PROTAMINE SULFATEActive2000-01-25
• TRIFLUOROTHYMIDINEActive1996-06-20
• ISONIAZID BULK FORMActive1982-12-07
• AMINOACETIC ACIDActive1982-12-07
• BETA-ALANINEInactive2009-07-30
• MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF NIACINAMIDE IN JOBAN, IWAKI-CITY, FUKUSHIMA PREFECTURE, JAPAN.Inactive1993-03-08
• MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF GLYCINE IN IWAKI-CITY, FUKUSHIMA PREFECTURE, JAPAN.Inactive1992-02-28
• MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF ISONAZID IN JOBAN FACTORY, IWAKI-CITY, FUKUSHIMA PREFECTURE, JAPAN.Inactive1991-09-07
• MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF PROTAMINE SULFATE IN TOKYO, JAPAN.Inactive1991-05-21
• SULFADIAZINE SILVERInactive1991-05-14
• MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF SULFADIAZINE SILVER IN JAPAN.Inactive1991-05-14
• MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF 2-DEOXYCYTIDINE HYDROCHLORIDE IN TOKYO, JAPAN.Inactive1989-09-01
• 2,3,-DIDEOXYINOSINEInactive1989-04-08
• 2' DEOXYCYTIDINE HYDROCHLORIDE (BULK)Inactive1987-12-12

Showing 15 of 17 Drug Master Files.

FDA compliance signals

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