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List of Drug Master Files (JDMF) for Fostamatinib Disodium Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 Patheon Austria GmbH & Co KG (1)

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01 Fostamatinib Disodium Hexahydrate (1)

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01 U.S.A (1)

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2022-04-06
2022-04-06
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Looking for 1025687-58-4 / Fostamatinib Disodium Hexahydrate API manufacturers, exporters & distributors?

Fostamatinib Disodium Hexahydrate manufacturers, exporters & distributors 1

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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.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fostamatinib Disodium Hexahydrate manufacturer or Fostamatinib Disodium Hexahydrate supplier.

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.

API | Excipient name

Fostamatinib Disodium Hexahydrate

Synonyms

1025687-58-4, Fostamatinib disodium, R788 disodium, R788 (fostamatinib) disodium, R 788 sodium, R935788 (fostamatinib disodium, r788)

Cas Number

1025687-58-4

Unique Ingredient Identifier (UNII)

X9417132K8

About Fostamatinib Disodium Hexahydrate

Fostamatinib Disodium Anhydrous is the anhydrous form of fostamatinib disodium, an orally available Syk kinase inhibitor with potential anti-inflammatory and immunomodulating activities. Fostamatinib inhibits Syk kinase-mediated IgG Fc gamma receptor signaling, resulting in inhibition of the activation of mast cells, macrophages, and B-cells and related inflammatory responses and tissue damage. Syk kinase, widely expressed in hematopoietic cells, is a nonreceptor tyrosine kinase that is involved in coupling activated immunoreceptors to signal downstream events that mediate diverse cellular responses, including proliferation, differentiation, and phagocytosis.

Fostamatinib Disodium Manufacturers

A Fostamatinib Disodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fostamatinib Disodium, including repackagers and relabelers. The FDA regulates Fostamatinib Disodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fostamatinib Disodium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Fostamatinib Disodium Suppliers

A Fostamatinib Disodium supplier is an individual or a company that provides Fostamatinib Disodium active pharmaceutical ingredient (API) or Fostamatinib Disodium finished formulations upon request. The Fostamatinib Disodium suppliers may include Fostamatinib Disodium API manufacturers, exporters, distributors and traders.

click here to find a list of Fostamatinib Disodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Fostamatinib Disodium JDMF

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 Drug Master File in Japan (Fostamatinib Disodium JDMF) empowers Fostamatinib Disodium 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Fostamatinib Disodium 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 suppliers with JDMF on PharmaCompass.

Fostamatinib Disodium Manufacturers | Traders | Suppliers

Fostamatinib Disodium Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Fostamatinib Disodium

Get in contact with the supplier of your choice:

  1. Patheon
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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