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
33
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A Breathtek ubt for h-pylori manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Breathtek ubt for h-pylori, including repackagers and relabelers. The FDA regulates Breathtek ubt for h-pylori manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Breathtek ubt for h-pylori API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Breathtek ubt for h-pylori DMF (Drug Master File) is a document detailing the whole manufacturing process of Breathtek ubt for h-pylori active pharmaceutical ingredient (API) in detail. Different forms of Breathtek ubt for h-pylori DMFs exist exist since differing nations have different regulations, such as Breathtek ubt for h-pylori USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Breathtek ubt for h-pylori DMF submitted to regulatory agencies in the US is known as a USDMF. Breathtek ubt for h-pylori USDMF includes data on Breathtek ubt for h-pylori's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Breathtek ubt for h-pylori USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 7 companies offering Breathtek ubt for h-pylori
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