01 1Gedeon Richter
02 1Medimpex
03 1Pliva Hrvatska
04 2Blank
01 1GLUETHIMIDE
02 2GLUTETHIMIDE
03 1GLUTETHIMIDE (CHEM NAME: 2-ETHYL-2-PHENYL GLUTARIMIDE)
04 1GLUTETHIMIDE BULK
01 1Croatia
02 1Hungary
03 1United Kingdom
04 2Blank
01 5Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12616
Submission : 1997-06-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4005
Submission : 1980-11-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4168
Submission : 1981-05-07
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2293
Submission : 1974-06-21
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1914
Submission : 1972-04-12
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Glutethimide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glutethimide, including repackagers and relabelers. The FDA regulates Glutethimide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glutethimide 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 Glutethimide supplier is an individual or a company that provides Glutethimide active pharmaceutical ingredient (API) or Glutethimide finished formulations upon request. The Glutethimide suppliers may include Glutethimide API manufacturers, exporters, distributors and traders.
click here to find a list of Glutethimide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glutethimide DMF (Drug Master File) is a document detailing the whole manufacturing process of Glutethimide active pharmaceutical ingredient (API) in detail. Different forms of Glutethimide DMFs exist exist since differing nations have different regulations, such as Glutethimide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glutethimide DMF submitted to regulatory agencies in the US is known as a USDMF. Glutethimide USDMF includes data on Glutethimide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glutethimide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glutethimide suppliers with USDMF on PharmaCompass.
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