01 1Katayama Seiyakusyo
01 1LOMEFLOXACIN HYDROCHLORIDE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19132
Submission : 2006-01-26
Status : Inactive
Type : II
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A Lomefloxacin HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lomefloxacin HCl, including repackagers and relabelers. The FDA regulates Lomefloxacin HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lomefloxacin HCl 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 Lomefloxacin HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Lomefloxacin HCl supplier is an individual or a company that provides Lomefloxacin HCl active pharmaceutical ingredient (API) or Lomefloxacin HCl finished formulations upon request. The Lomefloxacin HCl suppliers may include Lomefloxacin HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Lomefloxacin HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Lomefloxacin HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Lomefloxacin HCl active pharmaceutical ingredient (API) in detail. Different forms of Lomefloxacin HCl DMFs exist exist since differing nations have different regulations, such as Lomefloxacin HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lomefloxacin HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Lomefloxacin HCl USDMF includes data on Lomefloxacin HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lomefloxacin HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
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