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