01 1Mitsui & Co.,Ltd
01 1POLYPHENON E (NON TOPICAL USE)
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22693
Submission : 2009-03-31
Status : Active
Type : II
A ( -)-Catechin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ( -)-Catechin, including repackagers and relabelers. The FDA regulates ( -)-Catechin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ( -)-Catechin 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 ( -)-Catechin supplier is an individual or a company that provides ( -)-Catechin active pharmaceutical ingredient (API) or ( -)-Catechin finished formulations upon request. The ( -)-Catechin suppliers may include ( -)-Catechin API manufacturers, exporters, distributors and traders.
click here to find a list of ( -)-Catechin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ( -)-Catechin DMF (Drug Master File) is a document detailing the whole manufacturing process of ( -)-Catechin active pharmaceutical ingredient (API) in detail. Different forms of ( -)-Catechin DMFs exist exist since differing nations have different regulations, such as ( -)-Catechin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ( -)-Catechin DMF submitted to regulatory agencies in the US is known as a USDMF. ( -)-Catechin USDMF includes data on ( -)-Catechin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ( -)-Catechin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ( -)-Catechin suppliers with USDMF on PharmaCompass.
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