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 : 2021-04-30
Pay. Date : 2020-11-30
DMF Number : 31564
Submission : 2017-03-21
Status : Active
Type : II
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 : 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 Threonine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Threonine, including repackagers and relabelers. The FDA regulates Threonine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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 Threonine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Threonine supplier is an individual or a company that provides Threonine active pharmaceutical ingredient (API) or Threonine finished formulations upon request. The Threonine suppliers may include Threonine API manufacturers, exporters, distributors and traders.
click here to find a list of Threonine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Threonine DMF (Drug Master File) is a document detailing the whole manufacturing process of Threonine active pharmaceutical ingredient (API) in detail. Different forms of Threonine DMFs exist exist since differing nations have different regulations, such as Threonine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Threonine DMF submitted to regulatory agencies in the US is known as a USDMF. Threonine USDMF includes data on Threonine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Threonine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Threonine suppliers with USDMF on PharmaCompass.
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