01 1Borregaard
01 15-AMINO-N,N'-BIS(2,3-DIHYDROXYPROPYL)-ISOPHTALAMIDE-HYDROCHLORIDE
01 1Norway
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6720
Submission : 1986-12-05
Status : Inactive
Type : II
36
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A 5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride, including repackagers and relabelers. The FDA regulates 5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride 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 5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride supplier is an individual or a company that provides 5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride active pharmaceutical ingredient (API) or 5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride finished formulations upon request. The 5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride suppliers may include 5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride API manufacturers, exporters, distributors and traders.
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A 5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of 5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of 5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride DMFs exist exist since differing nations have different regulations, such as 5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. 5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride USDMF includes data on 5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 5-amino-N1,N3-bis(2,3-dihydroxypropyl)benzene-1,3-dicarboxamide hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
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