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
A Green Tea Extract manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Green Tea Extract, including repackagers and relabelers. The FDA regulates Green Tea Extract manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Green Tea Extract 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 Green Tea Extract manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Green Tea Extract supplier is an individual or a company that provides Green Tea Extract active pharmaceutical ingredient (API) or Green Tea Extract finished formulations upon request. The Green Tea Extract suppliers may include Green Tea Extract API manufacturers, exporters, distributors and traders.
click here to find a list of Green Tea Extract suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Green Tea Extract DMF (Drug Master File) is a document detailing the whole manufacturing process of Green Tea Extract active pharmaceutical ingredient (API) in detail. Different forms of Green Tea Extract DMFs exist exist since differing nations have different regulations, such as Green Tea Extract USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Green Tea Extract DMF submitted to regulatory agencies in the US is known as a USDMF. Green Tea Extract USDMF includes data on Green Tea Extract's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Green Tea Extract USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Green Tea Extract suppliers with USDMF on PharmaCompass.
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