01 1Aurore Life Sciences
02 1Katsura Chemical
01 1NAFAMOSTAT MESILATE JP
02 1NAFAMOSTAT MESILATE-K (USAN: NAFAMOSTAT MESYLATE)
01 1India
02 1Japan
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36046
Submission : 2021-07-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36042
Submission : 2021-12-09
Status : Active
Type : II
A Nafamostat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nafamostat, including repackagers and relabelers. The FDA regulates Nafamostat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nafamostat 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 Nafamostat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nafamostat supplier is an individual or a company that provides Nafamostat active pharmaceutical ingredient (API) or Nafamostat finished formulations upon request. The Nafamostat suppliers may include Nafamostat API manufacturers, exporters, distributors and traders.
click here to find a list of Nafamostat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nafamostat DMF (Drug Master File) is a document detailing the whole manufacturing process of Nafamostat active pharmaceutical ingredient (API) in detail. Different forms of Nafamostat DMFs exist exist since differing nations have different regulations, such as Nafamostat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nafamostat DMF submitted to regulatory agencies in the US is known as a USDMF. Nafamostat USDMF includes data on Nafamostat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nafamostat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nafamostat suppliers with USDMF on PharmaCompass.
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