01 1Avanos
02 1BioSpectra
03 1Cambridge Isotope Laboratories
04 1ISP Sutton Laboratories
05 1Merck Group
06 1PerkinElmer
07 1SAFC
01 113C UREA
02 1GERMALL II (DIAZOLIDINYL UREA)
03 1UREA
04 1UREA ACTIVE PHARMACEUTICAL INGREDIENT
05 1UREA-13 C
06 1[14C]-UREA
07 1[14C]-UREA, USP (PYTEST DRUG SUBSTANCE)
01 1Germany
02 6U.S.A
01 5Active
02 2Inactive
01 1Complete
02 6Blank
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 5519
Submission : 1984-09-05
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-24
Pay. Date : 2016-07-26
DMF Number : 29874
Submission : 2015-10-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10161
Submission : 1993-03-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11455
Submission : 1995-04-17
Status : Active
Type : II
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.
A Urea API DMF (Drug Master File) is a document detailing the whole manufacturing process of Urea API active pharmaceutical ingredient (API) in detail. Different forms of Urea API DMFs exist exist since differing nations have different regulations, such as Urea API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Urea API DMF submitted to regulatory agencies in the US is known as a USDMF. Urea API USDMF includes data on Urea API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Urea API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Urea API suppliers with USDMF on PharmaCompass.
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