01 1Mitsui & Co.,Ltd
01 1POLYPHENON E (USAN: SINECATECHINS)
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20492
Submission : 2007-04-27
Status : Active
Type : II
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A (-)-Epigallocatechin gallate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (-)-Epigallocatechin gallate, including repackagers and relabelers. The FDA regulates (-)-Epigallocatechin gallate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (-)-Epigallocatechin gallate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of (-)-Epigallocatechin gallate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A (-)-Epigallocatechin gallate supplier is an individual or a company that provides (-)-Epigallocatechin gallate active pharmaceutical ingredient (API) or (-)-Epigallocatechin gallate finished formulations upon request. The (-)-Epigallocatechin gallate suppliers may include (-)-Epigallocatechin gallate API manufacturers, exporters, distributors and traders.
click here to find a list of (-)-Epigallocatechin gallate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A (-)-Epigallocatechin gallate DMF (Drug Master File) is a document detailing the whole manufacturing process of (-)-Epigallocatechin gallate active pharmaceutical ingredient (API) in detail. Different forms of (-)-Epigallocatechin gallate DMFs exist exist since differing nations have different regulations, such as (-)-Epigallocatechin gallate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (-)-Epigallocatechin gallate DMF submitted to regulatory agencies in the US is known as a USDMF. (-)-Epigallocatechin gallate USDMF includes data on (-)-Epigallocatechin gallate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (-)-Epigallocatechin gallate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of (-)-Epigallocatechin gallate suppliers with USDMF on PharmaCompass.
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