01 1Juzen Chemical Corporation
01 1PRULIFLOXACIN
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17667
Submission : 2004-09-03
Status : Active
Type : II
A Prulifloxacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prulifloxacin, including repackagers and relabelers. The FDA regulates Prulifloxacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prulifloxacin 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 Prulifloxacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prulifloxacin supplier is an individual or a company that provides Prulifloxacin active pharmaceutical ingredient (API) or Prulifloxacin finished formulations upon request. The Prulifloxacin suppliers may include Prulifloxacin API manufacturers, exporters, distributors and traders.
click here to find a list of Prulifloxacin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prulifloxacin DMF (Drug Master File) is a document detailing the whole manufacturing process of Prulifloxacin active pharmaceutical ingredient (API) in detail. Different forms of Prulifloxacin DMFs exist exist since differing nations have different regulations, such as Prulifloxacin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prulifloxacin DMF submitted to regulatory agencies in the US is known as a USDMF. Prulifloxacin USDMF includes data on Prulifloxacin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prulifloxacin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prulifloxacin suppliers with USDMF on PharmaCompass.
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