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 441045-17-6 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 441045-17-6, including repackagers and relabelers. The FDA regulates 441045-17-6 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 441045-17-6 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 441045-17-6 supplier is an individual or a company that provides 441045-17-6 active pharmaceutical ingredient (API) or 441045-17-6 finished formulations upon request. The 441045-17-6 suppliers may include 441045-17-6 API manufacturers, exporters, distributors and traders.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 441045-17-6 Drug Master File in Korea (441045-17-6 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 441045-17-6. The MFDS reviews the 441045-17-6 KDMF as part of the drug registration process and uses the information provided in the 441045-17-6 KDMF to evaluate the safety and efficacy of the drug.
After submitting a 441045-17-6 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 441045-17-6 API can apply through the Korea Drug Master File (KDMF).
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