01 1Patheon Austria GmbH & Co KG
01 1Fostamatinib Disodium Hexahydrate
01 1U.S.A
Fostamatinib Disodium Hexahydrate
Registration Number : 304MF10064
Registrant's Address : St. -Peter-Strasse 25, 4020 Linz / Austria
Initial Date of Registration : 2022-04-06
Latest Date of Registration : 2022-04-06
A Fostamatinib Disodium Hexahydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fostamatinib Disodium Hexahydrate, including repackagers and relabelers. The FDA regulates Fostamatinib Disodium Hexahydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fostamatinib Disodium Hexahydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Fostamatinib Disodium Hexahydrate supplier is an individual or a company that provides Fostamatinib Disodium Hexahydrate active pharmaceutical ingredient (API) or Fostamatinib Disodium Hexahydrate finished formulations upon request. The Fostamatinib Disodium Hexahydrate suppliers may include Fostamatinib Disodium Hexahydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Fostamatinib Disodium Hexahydrate 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 Fostamatinib Disodium Hexahydrate Drug Master File in Japan (Fostamatinib Disodium Hexahydrate JDMF) empowers Fostamatinib Disodium Hexahydrate 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 Fostamatinib Disodium Hexahydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Fostamatinib Disodium Hexahydrate 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 Fostamatinib Disodium Hexahydrate suppliers with JDMF on PharmaCompass.
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