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