01 1Gattefosse
01 1TRANSCUTOL
01 1France
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5718
Submission : 1985-02-11
Status : Active
Type : IV
A Diethylene Glycol Monoethyl Ether manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diethylene Glycol Monoethyl Ether, including repackagers and relabelers. The FDA regulates Diethylene Glycol Monoethyl Ether manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diethylene Glycol Monoethyl Ether 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 Diethylene Glycol Monoethyl Ether supplier is an individual or a company that provides Diethylene Glycol Monoethyl Ether active pharmaceutical ingredient (API) or Diethylene Glycol Monoethyl Ether finished formulations upon request. The Diethylene Glycol Monoethyl Ether suppliers may include Diethylene Glycol Monoethyl Ether API manufacturers, exporters, distributors and traders.
click here to find a list of Diethylene Glycol Monoethyl Ether suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Diethylene Glycol Monoethyl Ether DMF (Drug Master File) is a document detailing the whole manufacturing process of Diethylene Glycol Monoethyl Ether active pharmaceutical ingredient (API) in detail. Different forms of Diethylene Glycol Monoethyl Ether DMFs exist exist since differing nations have different regulations, such as Diethylene Glycol Monoethyl Ether USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diethylene Glycol Monoethyl Ether DMF submitted to regulatory agencies in the US is known as a USDMF. Diethylene Glycol Monoethyl Ether USDMF includes data on Diethylene Glycol Monoethyl Ether's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diethylene Glycol Monoethyl Ether USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Diethylene Glycol Monoethyl Ether suppliers with USDMF on PharmaCompass.
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