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
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PharmaCompass offers a list of Dimethylethanolamine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Dimethylethanolamine manufacturer or Dimethylethanolamine supplier for your needs.
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A DMAE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DMAE, including repackagers and relabelers. The FDA regulates DMAE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DMAE 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 DMAE supplier is an individual or a company that provides DMAE active pharmaceutical ingredient (API) or DMAE finished formulations upon request. The DMAE suppliers may include DMAE API manufacturers, exporters, distributors and traders.
click here to find a list of DMAE suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A DMAE DMF (Drug Master File) is a document detailing the whole manufacturing process of DMAE active pharmaceutical ingredient (API) in detail. Different forms of DMAE DMFs exist exist since differing nations have different regulations, such as DMAE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DMAE DMF submitted to regulatory agencies in the US is known as a USDMF. DMAE USDMF includes data on DMAE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DMAE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DMAE suppliers with USDMF on PharmaCompass.
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