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