01 1WEINAN HIGH TECH NEW ELECTRONIC CHEMICAL CO LTD
01 1P-[[(1S)-2-[4-(BENZOYLAMINO)-2-OXO-1(2H)-PYRIMIDINYL]-1-(HYDROXYMETHYL)ETHOXY]METHYL]PHOSPHONIC ACID DIETHYL ESTER
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28117
Submission : 2014-02-09
Status : Active
Type : II
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A 1,2-dimethyl-ethane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1,2-dimethyl-ethane, including repackagers and relabelers. The FDA regulates 1,2-dimethyl-ethane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1,2-dimethyl-ethane 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 1,2-dimethyl-ethane supplier is an individual or a company that provides 1,2-dimethyl-ethane active pharmaceutical ingredient (API) or 1,2-dimethyl-ethane finished formulations upon request. The 1,2-dimethyl-ethane suppliers may include 1,2-dimethyl-ethane API manufacturers, exporters, distributors and traders.
click here to find a list of 1,2-dimethyl-ethane suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A 1,2-dimethyl-ethane DMF (Drug Master File) is a document detailing the whole manufacturing process of 1,2-dimethyl-ethane active pharmaceutical ingredient (API) in detail. Different forms of 1,2-dimethyl-ethane DMFs exist exist since differing nations have different regulations, such as 1,2-dimethyl-ethane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1,2-dimethyl-ethane DMF submitted to regulatory agencies in the US is known as a USDMF. 1,2-dimethyl-ethane USDMF includes data on 1,2-dimethyl-ethane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1,2-dimethyl-ethane USDMF is kept confidential to protect the manufacturer’s intellectual property.
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