01 1Kashima Plant, Eisai Co., Ltd.
01 1Korea Ezai Co., Ltd.
01 1Eribulin mesylate
01 1Japan
Registrant Name : Korea Ezai Co., Ltd.
Registration Date : 2012-08-09
Registration Number : Su3834-1-ND
Manufacturer Name : Kashima Plant, Eisai Co., Lt...
Manufacturer Address : 22 Sunayama, Kamisu-shi, Ibaraki-ken 314-0255
A Eribulin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eribulin, including repackagers and relabelers. The FDA regulates Eribulin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eribulin 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 Eribulin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eribulin supplier is an individual or a company that provides Eribulin active pharmaceutical ingredient (API) or Eribulin finished formulations upon request. The Eribulin suppliers may include Eribulin API manufacturers, exporters, distributors and traders.
click here to find a list of Eribulin 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 Eribulin Drug Master File in Korea (Eribulin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eribulin. The MFDS reviews the Eribulin KDMF as part of the drug registration process and uses the information provided in the Eribulin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eribulin 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 Eribulin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eribulin suppliers with KDMF on PharmaCompass.
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