01 1Hetero Drugs
01 1FOSTAMATINIB DISODIUM HEXAHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-04
Pay. Date : 2022-01-05
DMF Number : 36629
Submission : 2022-02-04
Status : Active
Type : II
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.
A Fostamatinib Disodium Hexahydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Fostamatinib Disodium Hexahydrate active pharmaceutical ingredient (API) in detail. Different forms of Fostamatinib Disodium Hexahydrate DMFs exist exist since differing nations have different regulations, such as Fostamatinib Disodium Hexahydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fostamatinib Disodium Hexahydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Fostamatinib Disodium Hexahydrate USDMF includes data on Fostamatinib Disodium Hexahydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fostamatinib Disodium Hexahydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fostamatinib Disodium Hexahydrate suppliers with USDMF on PharmaCompass.
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