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
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PharmaCompass offers a list of Fostamatinib Disodium Hexahydrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Fostamatinib Disodium Hexahydrate manufacturer or Fostamatinib Disodium Hexahydrate supplier for your needs.
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PharmaCompass also assists you with knowing the Fostamatinib Disodium Hexahydrate API Price utilized in the formulation of products. Fostamatinib Disodium Hexahydrate API Price is not always fixed or binding as the Fostamatinib Disodium Hexahydrate Price is obtained through a variety of data sources. The Fostamatinib Disodium Hexahydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fostamatinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fostamatinib, including repackagers and relabelers. The FDA regulates Fostamatinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fostamatinib 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 supplier is an individual or a company that provides Fostamatinib active pharmaceutical ingredient (API) or Fostamatinib finished formulations upon request. The Fostamatinib suppliers may include Fostamatinib API manufacturers, exporters, distributors and traders.
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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 Drug Master File in Japan (Fostamatinib JDMF) empowers Fostamatinib 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Fostamatinib JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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