01 1ANGUS Chemical Company
02 1Abbott Laboratories
03 1BioSpectra
04 1F. Hoffmann-La Roche
05 1SIGMA TAU
06 1Takara Bio
07 1The Mosaic Company
01 110X M BUFFER
02 1RS-37619-00-31-3 (RS-37619, TROMETHAMINE SALT)
03 1TRIZMA BASE AS PROCESSED IN THE SAINT LOUIS, MISSOURI FACILITIES
04 2TROMETHAMINE
05 1TROMETHAMINE (TRIS AMINO)
06 1TROMETHAMINE,USP
01 1France
02 1Switzerland
03 5U.S.A
01 2Active
02 5Inactive
01 1Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12635
Submission : 1997-08-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10599
Submission : 1993-11-29
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-10
Pay. Date : 2017-06-05
DMF Number : 31483
Submission : 2017-03-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3240
Submission : 1978-06-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4941
Submission : 1983-04-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41942
Submission : 2025-05-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 434
Submission : 1961-06-22
Status : Inactive
Type : II
85
PharmaCompass offers a list of Tromethamine API API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Tromethamine API manufacturer or Tromethamine API supplier for your needs.
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A Tris-base manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tris-base, including repackagers and relabelers. The FDA regulates Tris-base manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tris-base 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 Tris-base manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tris-base supplier is an individual or a company that provides Tris-base active pharmaceutical ingredient (API) or Tris-base finished formulations upon request. The Tris-base suppliers may include Tris-base API manufacturers, exporters, distributors and traders.
click here to find a list of Tris-base suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tris-base DMF (Drug Master File) is a document detailing the whole manufacturing process of Tris-base active pharmaceutical ingredient (API) in detail. Different forms of Tris-base DMFs exist exist since differing nations have different regulations, such as Tris-base USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tris-base DMF submitted to regulatory agencies in the US is known as a USDMF. Tris-base USDMF includes data on Tris-base's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tris-base USDMF is kept confidential to protect the manufacturer’s intellectual property.
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