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 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.
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.
A Fostamatinib Disodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Fostamatinib Disodium active pharmaceutical ingredient (API) in detail. Different forms of Fostamatinib Disodium DMFs exist exist since differing nations have different regulations, such as Fostamatinib Disodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fostamatinib Disodium DMF submitted to regulatory agencies in the US is known as a USDMF. Fostamatinib Disodium USDMF includes data on Fostamatinib Disodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fostamatinib Disodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fostamatinib Disodium suppliers with USDMF on PharmaCompass.
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