01 1BrightGene Bio-Medical Technology Co.,Ltd
01 12-AMINO-1,9-DIHYDRO-9-[(1S,3R,4S)-4-(BENZYLOXY)-3-(BENZYLOXYMETHYL)-2-METHYLENE CYCLOPENTYL]-6H-PURINE-6-ONE(ET1)
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26257
Submission : 2012-08-12
Status : Active
Type : II
A Entecavir Intermediate VIII Isomer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Entecavir Intermediate VIII Isomer, including repackagers and relabelers. The FDA regulates Entecavir Intermediate VIII Isomer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Entecavir Intermediate VIII Isomer 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 Entecavir Intermediate VIII Isomer supplier is an individual or a company that provides Entecavir Intermediate VIII Isomer active pharmaceutical ingredient (API) or Entecavir Intermediate VIII Isomer finished formulations upon request. The Entecavir Intermediate VIII Isomer suppliers may include Entecavir Intermediate VIII Isomer API manufacturers, exporters, distributors and traders.
click here to find a list of Entecavir Intermediate VIII Isomer suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Entecavir Intermediate VIII Isomer DMF (Drug Master File) is a document detailing the whole manufacturing process of Entecavir Intermediate VIII Isomer active pharmaceutical ingredient (API) in detail. Different forms of Entecavir Intermediate VIII Isomer DMFs exist exist since differing nations have different regulations, such as Entecavir Intermediate VIII Isomer USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Entecavir Intermediate VIII Isomer DMF submitted to regulatory agencies in the US is known as a USDMF. Entecavir Intermediate VIII Isomer USDMF includes data on Entecavir Intermediate VIII Isomer's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Entecavir Intermediate VIII Isomer USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Entecavir Intermediate VIII Isomer suppliers with USDMF on PharmaCompass.
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