01 1ANGUS Chemical Company
02 1Abbott Laboratories
03 1BioSpectra
04 1F. Hoffmann-La Roche
05 1SIGMA TAU
06 1The Mosaic Company
01 1RS-37619-00-31-3 (RS-37619, TROMETHAMINE SALT)
02 1TRIZMA BASE AS PROCESSED IN THE SAINT LOUIS, MISSOURI FACILITIES
03 2TROMETHAMINE
04 1TROMETHAMINE (TRIS AMINO)
05 1TROMETHAMINE,USP
01 1Switzerland
02 5U.S.A
01 1Active
02 5Inactive
01 1Complete
02 5Blank
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 : 434
Submission : 1961-06-22
Status : Inactive
Type : II
A Tromethamine API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tromethamine API, including repackagers and relabelers. The FDA regulates Tromethamine API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tromethamine 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 Tromethamine API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tromethamine API supplier is an individual or a company that provides Tromethamine API active pharmaceutical ingredient (API) or Tromethamine API finished formulations upon request. The Tromethamine API suppliers may include Tromethamine API API manufacturers, exporters, distributors and traders.
click here to find a list of Tromethamine API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tromethamine API DMF (Drug Master File) is a document detailing the whole manufacturing process of Tromethamine API active pharmaceutical ingredient (API) in detail. Different forms of Tromethamine API DMFs exist exist since differing nations have different regulations, such as Tromethamine API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tromethamine API DMF submitted to regulatory agencies in the US is known as a USDMF. Tromethamine API USDMF includes data on Tromethamine API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tromethamine API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tromethamine API suppliers with USDMF on PharmaCompass.
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