01 1Otsuka Chemical Co Ltd
01 1NADIFLOXACIN DRUG SUBSTANCE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12418
Submission : 1997-03-01
Status : Inactive
Type : II
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A Nadifloxacine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nadifloxacine, including repackagers and relabelers. The FDA regulates Nadifloxacine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nadifloxacine 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 Nadifloxacine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Nadifloxacine supplier is an individual or a company that provides Nadifloxacine active pharmaceutical ingredient (API) or Nadifloxacine finished formulations upon request. The Nadifloxacine suppliers may include Nadifloxacine API manufacturers, exporters, distributors and traders.
click here to find a list of Nadifloxacine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Nadifloxacine DMF (Drug Master File) is a document detailing the whole manufacturing process of Nadifloxacine active pharmaceutical ingredient (API) in detail. Different forms of Nadifloxacine DMFs exist exist since differing nations have different regulations, such as Nadifloxacine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nadifloxacine DMF submitted to regulatory agencies in the US is known as a USDMF. Nadifloxacine USDMF includes data on Nadifloxacine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nadifloxacine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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