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