01 1Kemport Co., Ltd.
01 1Kemport Co., Ltd.
01 1Ethyl icosapentate
01 1United Kingdom
Registrant Name : Kemport Co., Ltd.
Registration Date : 2022-08-22
Registration Number : 20220822-211-J-1348
Manufacturer Name : Kemport Co., Ltd.
Manufacturer Address : Laboratory: 2nd floor, Research Building, 52, Goha-daero 719beongil, Mokpo-si, Jeolla...
A Icosapent manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Icosapent, including repackagers and relabelers. The FDA regulates Icosapent manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Icosapent 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 Icosapent manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Icosapent supplier is an individual or a company that provides Icosapent active pharmaceutical ingredient (API) or Icosapent finished formulations upon request. The Icosapent suppliers may include Icosapent API manufacturers, exporters, distributors and traders.
click here to find a list of Icosapent 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 Icosapent Drug Master File in Korea (Icosapent KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Icosapent. The MFDS reviews the Icosapent KDMF as part of the drug registration process and uses the information provided in the Icosapent KDMF to evaluate the safety and efficacy of the drug.
After submitting a Icosapent 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 Icosapent API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Icosapent suppliers with KDMF on PharmaCompass.
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