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