01 1Bristol Myers Squibb
02 1Sumitomo Pharma
01 1ENOXACIN SESQUIHYDRATE
02 1GARENOXACIN MESYLATE (BMS-284756-01) DRUG SUBSTANCE
01 1Japan
02 1U.S.A
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16546
Submission : 2003-04-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7252
Submission : 1987-12-09
Status : Inactive
Type : II
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A Pierre Fabre Brand of Enoxacin Sesquihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pierre Fabre Brand of Enoxacin Sesquihydrate, including repackagers and relabelers. The FDA regulates Pierre Fabre Brand of Enoxacin Sesquihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pierre Fabre Brand of Enoxacin Sesquihydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Pierre Fabre Brand of Enoxacin Sesquihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Pierre Fabre Brand of Enoxacin Sesquihydrate active pharmaceutical ingredient (API) in detail. Different forms of Pierre Fabre Brand of Enoxacin Sesquihydrate DMFs exist exist since differing nations have different regulations, such as Pierre Fabre Brand of Enoxacin Sesquihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pierre Fabre Brand of Enoxacin Sesquihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Pierre Fabre Brand of Enoxacin Sesquihydrate USDMF includes data on Pierre Fabre Brand of Enoxacin Sesquihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pierre Fabre Brand of Enoxacin Sesquihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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