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