01 1AMINO GmbH
02 2Ajinomoto Company
03 2Mitsubishi Tanabe Pharma
04 1SIGMA TAU
01 6L-THREONINE
01 1Germany
02 4Japan
03 1U.S.A
01 3Active
02 3Inactive
01 2Complete
02 4Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-12
Pay. Date : 2017-04-17
DMF Number : 29306
Submission : 2015-04-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-04-30
Pay. Date : 2020-11-30
DMF Number : 31564
Submission : 2017-03-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34526
Submission : 2020-03-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10061
Submission : 1993-01-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1248
Submission : 1968-10-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9992
Submission : 1992-11-25
Status : Inactive
Type : II
A L-Threonine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Threonine, including repackagers and relabelers. The FDA regulates L-Threonine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Threonine 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 L-Threonine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Threonine supplier is an individual or a company that provides L-Threonine active pharmaceutical ingredient (API) or L-Threonine finished formulations upon request. The L-Threonine suppliers may include L-Threonine API manufacturers, exporters, distributors and traders.
click here to find a list of L-Threonine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Threonine DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Threonine active pharmaceutical ingredient (API) in detail. Different forms of L-Threonine DMFs exist exist since differing nations have different regulations, such as L-Threonine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Threonine DMF submitted to regulatory agencies in the US is known as a USDMF. L-Threonine USDMF includes data on L-Threonine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Threonine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Threonine suppliers with USDMF on PharmaCompass.
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