01 1GOLDEN SHELL BIOCHEMICAL CO LTD
02 1Nippon Protein Co Ltd
01 2N-ACETYL-D-GLUCOSAMINE
01 1China
02 1Japan
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25181
Submission : 2011-07-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10770
Submission : 1994-03-11
Status : Inactive
Type : II
A N-Acetylglucosamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N-Acetylglucosamine, including repackagers and relabelers. The FDA regulates N-Acetylglucosamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N-Acetylglucosamine 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 N-Acetylglucosamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A N-Acetylglucosamine supplier is an individual or a company that provides N-Acetylglucosamine active pharmaceutical ingredient (API) or N-Acetylglucosamine finished formulations upon request. The N-Acetylglucosamine suppliers may include N-Acetylglucosamine API manufacturers, exporters, distributors and traders.
click here to find a list of N-Acetylglucosamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A N-Acetylglucosamine DMF (Drug Master File) is a document detailing the whole manufacturing process of N-Acetylglucosamine active pharmaceutical ingredient (API) in detail. Different forms of N-Acetylglucosamine DMFs exist exist since differing nations have different regulations, such as N-Acetylglucosamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A N-Acetylglucosamine DMF submitted to regulatory agencies in the US is known as a USDMF. N-Acetylglucosamine USDMF includes data on N-Acetylglucosamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The N-Acetylglucosamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of N-Acetylglucosamine suppliers with USDMF on PharmaCompass.
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