01 1Avanos
02 1BioSpectra
03 1Cambridge Isotope Laboratories
04 1ISP Sutton Laboratories
05 1Merck Group
06 1PerkinElmer
07 1SAFC
08 1Takasugi Pharmaceutical
01 1Germany
02 1Japan
03 6U.S.A
01 5Active
02 2Inactive
03 1Blank
01 1Valid
02 7Blank
01 1218MF10723
02 7Blank
01 8Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18942
Submission : 2005-11-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31669
Submission : 2017-04-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11378
Submission : 1995-03-16
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-24
Pay. Date : 2016-07-26
DMF Number : 29874
Submission : 2015-10-06
Status : Active
Type : II
Certificate Number : R1-CEP 2011-045 - Rev 01
Issue Date : 2017-11-09
Type : Chemical
Substance Number : 743
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11455
Submission : 1995-04-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5519
Submission : 1984-09-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10161
Submission : 1993-03-23
Status : Inactive
Type : II
Registration Number : 218MF10723
Registrant's Address : 2-7-26 Yoshizuka, Hakata-ku, Fukuoka City, Fukuoka Prefecture
Initial Date of Registration : 2006-09-06
Latest Date of Registration : --
A Urea API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Urea API, including repackagers and relabelers. The FDA regulates Urea API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Urea API API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Urea API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Urea API supplier is an individual or a company that provides Urea API active pharmaceutical ingredient (API) or Urea API finished formulations upon request. The Urea API suppliers may include Urea API API manufacturers, exporters, distributors and traders.
click here to find a list of Urea API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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