01 1Engichem Life Sciences Co., Ltd.
02 1Kukjeon Pharmaceutical Co., Ltd.
03 1Kyungbo Pharmaceutical Co., Ltd.
01 1Engichem Life Sciences Co., Ltd.
02 1Kukjeon Pharmaceutical Co., Ltd.
03 1Kyungbo Pharmaceutical Co., Ltd.
01 3Nafamostat mesylate
01 2South Korea
02 1Blank
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2014-08-01
Registration Number : 2520-14-ND
Manufacturer Name : Kukjeon Pharmaceutical Co., ...
Manufacturer Address : 8, Balan Industrial Complex-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2021-05-25
Registration Number : 1673-41-ND
Manufacturer Name : Kyungbo Pharmaceutical Co., ...
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do
Registrant Name : Engichem Life Sciences Co., Ltd.
Registration Date : 2014-10-22
Registration Number : 238-3-ND
Manufacturer Name : Engichem Life Sciences Co., ...
Manufacturer Address : 59 Biovalley-ro, Jecheon-si, Chungcheongbuk-do
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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.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Nafamostat Drug Master File in Korea (Nafamostat KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nafamostat. The MFDS reviews the Nafamostat KDMF as part of the drug registration process and uses the information provided in the Nafamostat KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nafamostat KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Nafamostat API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nafamostat suppliers with KDMF on PharmaCompass.
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