01 1BrightGene Pharmaceutical Co. , Ltd.
02 1Eisai Co., Ltd.
01 2Eribulin Mesylate
01 1China
02 1Japan
Registration Number : 304MF10030
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2022-02-10
Latest Date of Registration : 2022-02-10
Registration Number : 301MF10104
Registrant's Address : 4-6-10 Koishikawa, Bunkyo-ku, Tokyo
Initial Date of Registration : 2019-12-10
Latest Date of Registration : 2019-12-10
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.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Eribulin Drug Master File in Japan (Eribulin JDMF) empowers Eribulin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Eribulin JDMF during the approval evaluation for pharmaceutical products. At the time of Eribulin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Eribulin suppliers with JDMF on PharmaCompass.
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