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