01 1Mitsubishi Tanabe Pharma
01 1DL-THREONINE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1318
Submission : 1969-01-23
Status : Inactive
Type : II
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A Allo-DL-threonine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Allo-DL-threonine, including repackagers and relabelers. The FDA regulates Allo-DL-threonine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Allo-DL-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.
A Allo-DL-threonine supplier is an individual or a company that provides Allo-DL-threonine active pharmaceutical ingredient (API) or Allo-DL-threonine finished formulations upon request. The Allo-DL-threonine suppliers may include Allo-DL-threonine API manufacturers, exporters, distributors and traders.
click here to find a list of Allo-DL-threonine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Allo-DL-threonine DMF (Drug Master File) is a document detailing the whole manufacturing process of Allo-DL-threonine active pharmaceutical ingredient (API) in detail. Different forms of Allo-DL-threonine DMFs exist exist since differing nations have different regulations, such as Allo-DL-threonine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Allo-DL-threonine DMF submitted to regulatory agencies in the US is known as a USDMF. Allo-DL-threonine USDMF includes data on Allo-DL-threonine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Allo-DL-threonine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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