Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

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01 1Pfanstiehl
02 1ANGUS Chemical Company
03 1Abbott Laboratories
04 1BioSpectra
05 1F. Hoffmann-La Roche
06 1SIGMA TAU
07 1Takara Bio
08 1The Mosaic Company
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01 110X M BUFFER
02 1RS-37619-00-31-3 (RS-37619, TROMETHAMINE SALT)
03 1TRIS BASE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, USP, EP, BP, CHP (T-153)
04 1TRIZMA BASE AS PROCESSED IN THE SAINT LOUIS, MISSOURI FACILITIES
05 2TROMETHAMINE
06 1TROMETHAMINE (TRIS AMINO)
07 1TROMETHAMINE,USP
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01 1France
02 1Switzerland
03 6U.S.A
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01 3Active
02 5Inactive
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01 1Complete
02 7Blank
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42613
Submission : 2025-09-22
Status : Active
Type : II
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

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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 Tromethamolum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tromethamolum, including repackagers and relabelers. The FDA regulates Tromethamolum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tromethamolum 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 Tromethamolum supplier is an individual or a company that provides Tromethamolum active pharmaceutical ingredient (API) or Tromethamolum finished formulations upon request. The Tromethamolum suppliers may include Tromethamolum API manufacturers, exporters, distributors and traders.
click here to find a list of Tromethamolum suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tromethamolum DMF (Drug Master File) is a document detailing the whole manufacturing process of Tromethamolum active pharmaceutical ingredient (API) in detail. Different forms of Tromethamolum DMFs exist exist since differing nations have different regulations, such as Tromethamolum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tromethamolum DMF submitted to regulatory agencies in the US is known as a USDMF. Tromethamolum USDMF includes data on Tromethamolum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tromethamolum USDMF is kept confidential to protect the manufacturer’s intellectual property.
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