01 1Kashima Plant, Eisai Co., Ltd.
01 1Eisai Korea Co., Ltd.
01 1Eribulin mesylate
01 1Japan
Registrant Name : Eisai Korea 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
95
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A Halaven manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Halaven, including repackagers and relabelers. The FDA regulates Halaven manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Halaven 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 Halaven manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Halaven supplier is an individual or a company that provides Halaven active pharmaceutical ingredient (API) or Halaven finished formulations upon request. The Halaven suppliers may include Halaven API manufacturers, exporters, distributors and traders.
click here to find a list of Halaven suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Halaven Drug Master File in Korea (Halaven KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Halaven. The MFDS reviews the Halaven KDMF as part of the drug registration process and uses the information provided in the Halaven KDMF to evaluate the safety and efficacy of the drug.
After submitting a Halaven 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 Halaven API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Halaven suppliers with KDMF on PharmaCompass.
