01 1Merck & Co
01 12-METHOXYESTRADIOL
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20836
Submission : 2007-09-06
Status : Inactive
Type : II
A 2-Methoxyestradiol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 2-Methoxyestradiol, including repackagers and relabelers. The FDA regulates 2-Methoxyestradiol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 2-Methoxyestradiol 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 2-Methoxyestradiol supplier is an individual or a company that provides 2-Methoxyestradiol active pharmaceutical ingredient (API) or 2-Methoxyestradiol finished formulations upon request. The 2-Methoxyestradiol suppliers may include 2-Methoxyestradiol API manufacturers, exporters, distributors and traders.
click here to find a list of 2-Methoxyestradiol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 2-Methoxyestradiol DMF (Drug Master File) is a document detailing the whole manufacturing process of 2-Methoxyestradiol active pharmaceutical ingredient (API) in detail. Different forms of 2-Methoxyestradiol DMFs exist exist since differing nations have different regulations, such as 2-Methoxyestradiol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 2-Methoxyestradiol DMF submitted to regulatory agencies in the US is known as a USDMF. 2-Methoxyestradiol USDMF includes data on 2-Methoxyestradiol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 2-Methoxyestradiol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 2-Methoxyestradiol suppliers with USDMF on PharmaCompass.
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