01 1Mitsubishi Tanabe Pharma
01 1DL-TRYPTOPHAN
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1317
Submission : 1969-01-23
Status : Inactive
Type : II
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A Dl-Tryptophan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dl-Tryptophan, including repackagers and relabelers. The FDA regulates Dl-Tryptophan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dl-Tryptophan 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 Dl-Tryptophan supplier is an individual or a company that provides Dl-Tryptophan active pharmaceutical ingredient (API) or Dl-Tryptophan finished formulations upon request. The Dl-Tryptophan suppliers may include Dl-Tryptophan API manufacturers, exporters, distributors and traders.
click here to find a list of Dl-Tryptophan suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Dl-Tryptophan DMF (Drug Master File) is a document detailing the whole manufacturing process of Dl-Tryptophan active pharmaceutical ingredient (API) in detail. Different forms of Dl-Tryptophan DMFs exist exist since differing nations have different regulations, such as Dl-Tryptophan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dl-Tryptophan DMF submitted to regulatory agencies in the US is known as a USDMF. Dl-Tryptophan USDMF includes data on Dl-Tryptophan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dl-Tryptophan USDMF is kept confidential to protect the manufacturer’s intellectual property.
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