01 1Benzo Chem Industries Pvt
01 11-(2,6-DICHLOROPHENYL)-2-INDOLINONE
01 1India
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18300
Submission : 2004-10-29
Status : Inactive
Type : II
12
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A 1-(2,6-DICHLOROPHENYL)-2-INDOLINONE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1-(2,6-DICHLOROPHENYL)-2-INDOLINONE, including repackagers and relabelers. The FDA regulates 1-(2,6-DICHLOROPHENYL)-2-INDOLINONE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1-(2,6-DICHLOROPHENYL)-2-INDOLINONE 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 1-(2,6-DICHLOROPHENYL)-2-INDOLINONE supplier is an individual or a company that provides 1-(2,6-DICHLOROPHENYL)-2-INDOLINONE active pharmaceutical ingredient (API) or 1-(2,6-DICHLOROPHENYL)-2-INDOLINONE finished formulations upon request. The 1-(2,6-DICHLOROPHENYL)-2-INDOLINONE suppliers may include 1-(2,6-DICHLOROPHENYL)-2-INDOLINONE API manufacturers, exporters, distributors and traders.
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A 1-(2,6-DICHLOROPHENYL)-2-INDOLINONE DMF (Drug Master File) is a document detailing the whole manufacturing process of 1-(2,6-DICHLOROPHENYL)-2-INDOLINONE active pharmaceutical ingredient (API) in detail. Different forms of 1-(2,6-DICHLOROPHENYL)-2-INDOLINONE DMFs exist exist since differing nations have different regulations, such as 1-(2,6-DICHLOROPHENYL)-2-INDOLINONE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1-(2,6-DICHLOROPHENYL)-2-INDOLINONE DMF submitted to regulatory agencies in the US is known as a USDMF. 1-(2,6-DICHLOROPHENYL)-2-INDOLINONE USDMF includes data on 1-(2,6-DICHLOROPHENYL)-2-INDOLINONE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1-(2,6-DICHLOROPHENYL)-2-INDOLINONE USDMF is kept confidential to protect the manufacturer’s intellectual property.
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