01 1Hetero Drugs
02 1Patheon
01 1India
02 1U.S.A
01 1Active
02 1Blank
01 2Blank
01 1304MF10064
02 1Blank
01 2Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-04
Pay. Date : 2022-01-05
DMF Number : 36629
Submission : 2022-02-04
Status : Active
Type : II
NDC Package Code : 68554-0130
Start Marketing Date : 2018-04-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registration Number : 304MF10064
Registrant's Address : St. -Peter-Strasse 25, 4020 Linz / Austria
Initial Date of Registration : 2022-04-06
Latest Date of Registration : --
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.
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