01 1NOF CORPORATION
01 1[A-METHOXY-W-AMINOPROPYL, POLY (OXYETHYLENE)]-BLOCK-POLY (L-SODIUM GLUTAMATE)
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28196
Submission : 2014-04-10
Status : Inactive
Type : II
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A l-Monosodium glutamate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of l-Monosodium glutamate, including repackagers and relabelers. The FDA regulates l-Monosodium glutamate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. l-Monosodium glutamate 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 l-Monosodium glutamate supplier is an individual or a company that provides l-Monosodium glutamate active pharmaceutical ingredient (API) or l-Monosodium glutamate finished formulations upon request. The l-Monosodium glutamate suppliers may include l-Monosodium glutamate API manufacturers, exporters, distributors and traders.
click here to find a list of l-Monosodium glutamate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A l-Monosodium glutamate DMF (Drug Master File) is a document detailing the whole manufacturing process of l-Monosodium glutamate active pharmaceutical ingredient (API) in detail. Different forms of l-Monosodium glutamate DMFs exist exist since differing nations have different regulations, such as l-Monosodium glutamate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A l-Monosodium glutamate DMF submitted to regulatory agencies in the US is known as a USDMF. l-Monosodium glutamate USDMF includes data on l-Monosodium glutamate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The l-Monosodium glutamate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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