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