01 1ABX Advanced Biochemical Compounds
01 1DIMETHYLAMINOETHANOL
01 1Germany
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35031
Submission : 2020-11-17
Status : Active
Type : II
A Dimethylethanolamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dimethylethanolamine, including repackagers and relabelers. The FDA regulates Dimethylethanolamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dimethylethanolamine 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 Dimethylethanolamine supplier is an individual or a company that provides Dimethylethanolamine active pharmaceutical ingredient (API) or Dimethylethanolamine finished formulations upon request. The Dimethylethanolamine suppliers may include Dimethylethanolamine API manufacturers, exporters, distributors and traders.
click here to find a list of Dimethylethanolamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dimethylethanolamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Dimethylethanolamine active pharmaceutical ingredient (API) in detail. Different forms of Dimethylethanolamine DMFs exist exist since differing nations have different regulations, such as Dimethylethanolamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dimethylethanolamine DMF submitted to regulatory agencies in the US is known as a USDMF. Dimethylethanolamine USDMF includes data on Dimethylethanolamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dimethylethanolamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dimethylethanolamine suppliers with USDMF on PharmaCompass.
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