01 1EISAI PHARMACEUTICALS INDIA PVT LTD
02 1Eisai Co., Ltd.
01 1Fosravuconazole L-lysine ethanol adduct
02 1Hosurabu Kona tetrazole L- lysine ethanol adduct
01 2Japan
Fosravuconazole L-Lysine Ethanolate
Registration Number : 230MF10083
Registrant's Address : 4-6-10 Koishikawa, Bunkyo-ku, Tokyo
Initial Date of Registration : 2018-07-09
Latest Date of Registration : 2018-07-09
Fosravuconazole L-Lysine Ethanolate
Registration Number : 228MF10209
Registrant's Address : Ramky Pharma City (SEZ), Plot Nos. 96,97,98,124 & 126, Parawada-531 019, Visakhapatna...
Initial Date of Registration : 2016-11-09
Latest Date of Registration : 2016-11-09
A Fosravuconazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosravuconazole, including repackagers and relabelers. The FDA regulates Fosravuconazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosravuconazole 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 Fosravuconazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fosravuconazole supplier is an individual or a company that provides Fosravuconazole active pharmaceutical ingredient (API) or Fosravuconazole finished formulations upon request. The Fosravuconazole suppliers may include Fosravuconazole API manufacturers, exporters, distributors and traders.
click here to find a list of Fosravuconazole 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 Fosravuconazole Drug Master File in Japan (Fosravuconazole JDMF) empowers Fosravuconazole 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 Fosravuconazole JDMF during the approval evaluation for pharmaceutical products. At the time of Fosravuconazole 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 Fosravuconazole suppliers with JDMF on PharmaCompass.
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