01 1MSN Laboratories
01 1GILTERITINIB FUMARATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-23
Pay. Date : 2022-06-10
DMF Number : 36745
Submission : 2022-01-31
Status : Active
Type : II
A Gilteritinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gilteritinib, including repackagers and relabelers. The FDA regulates Gilteritinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gilteritinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Gilteritinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gilteritinib supplier is an individual or a company that provides Gilteritinib active pharmaceutical ingredient (API) or Gilteritinib finished formulations upon request. The Gilteritinib suppliers may include Gilteritinib API manufacturers, exporters, distributors and traders.
click here to find a list of Gilteritinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gilteritinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Gilteritinib active pharmaceutical ingredient (API) in detail. Different forms of Gilteritinib DMFs exist exist since differing nations have different regulations, such as Gilteritinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gilteritinib DMF submitted to regulatory agencies in the US is known as a USDMF. Gilteritinib USDMF includes data on Gilteritinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gilteritinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gilteritinib suppliers with USDMF on PharmaCompass.
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