01 1ASAHI GLASS CO LTD
01 1HYDRAZINE-DIOL
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17145
Submission : 2004-02-04
Status : Inactive
Type : II
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A Benzene-1,4-Diol;Hydrazine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzene-1,4-Diol;Hydrazine, including repackagers and relabelers. The FDA regulates Benzene-1,4-Diol;Hydrazine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzene-1,4-Diol;Hydrazine 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 Benzene-1,4-Diol;Hydrazine supplier is an individual or a company that provides Benzene-1,4-Diol;Hydrazine active pharmaceutical ingredient (API) or Benzene-1,4-Diol;Hydrazine finished formulations upon request. The Benzene-1,4-Diol;Hydrazine suppliers may include Benzene-1,4-Diol;Hydrazine API manufacturers, exporters, distributors and traders.
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A Benzene-1,4-Diol;Hydrazine DMF (Drug Master File) is a document detailing the whole manufacturing process of Benzene-1,4-Diol;Hydrazine active pharmaceutical ingredient (API) in detail. Different forms of Benzene-1,4-Diol;Hydrazine DMFs exist exist since differing nations have different regulations, such as Benzene-1,4-Diol;Hydrazine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benzene-1,4-Diol;Hydrazine DMF submitted to regulatory agencies in the US is known as a USDMF. Benzene-1,4-Diol;Hydrazine USDMF includes data on Benzene-1,4-Diol;Hydrazine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benzene-1,4-Diol;Hydrazine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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