01 1Mitsubishi Tanabe Pharma
01 1DL - METHIONINE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1832
Submission : 1971-12-17
Status : Inactive
Type : II
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A Pedameth manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pedameth, including repackagers and relabelers. The FDA regulates Pedameth manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pedameth 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 Pedameth manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Pedameth supplier is an individual or a company that provides Pedameth active pharmaceutical ingredient (API) or Pedameth finished formulations upon request. The Pedameth suppliers may include Pedameth API manufacturers, exporters, distributors and traders.
click here to find a list of Pedameth suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Pedameth DMF (Drug Master File) is a document detailing the whole manufacturing process of Pedameth active pharmaceutical ingredient (API) in detail. Different forms of Pedameth DMFs exist exist since differing nations have different regulations, such as Pedameth USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pedameth DMF submitted to regulatory agencies in the US is known as a USDMF. Pedameth USDMF includes data on Pedameth's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pedameth USDMF is kept confidential to protect the manufacturer’s intellectual property.
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