01 2Fujifilm Toyama Chemical
01 1T-3811(BMS-284756-01) DRUG SUBSTANCE
02 1T-3811ME DRUG SUBSTANCE
01 2Japan
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14393
Submission : 1999-09-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13935
Submission : 1999-01-12
Status : Inactive
Type : II
A Garenoxacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Garenoxacin, including repackagers and relabelers. The FDA regulates Garenoxacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Garenoxacin 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 Garenoxacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Garenoxacin supplier is an individual or a company that provides Garenoxacin active pharmaceutical ingredient (API) or Garenoxacin finished formulations upon request. The Garenoxacin suppliers may include Garenoxacin API manufacturers, exporters, distributors and traders.
click here to find a list of Garenoxacin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Garenoxacin DMF (Drug Master File) is a document detailing the whole manufacturing process of Garenoxacin active pharmaceutical ingredient (API) in detail. Different forms of Garenoxacin DMFs exist exist since differing nations have different regulations, such as Garenoxacin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Garenoxacin DMF submitted to regulatory agencies in the US is known as a USDMF. Garenoxacin USDMF includes data on Garenoxacin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Garenoxacin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Garenoxacin suppliers with USDMF on PharmaCompass.
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