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01 1MSN Laboratories
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01 1GILTERITINIB FUMARATE
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01 1India
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01 1Active
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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
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PharmaCompass offers a list of Gilteritinib Fumarate 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 Gilteritinib Fumarate manufacturer or Gilteritinib Fumarate supplier for your needs.
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PharmaCompass also assists you with knowing the Gilteritinib Fumarate API Price utilized in the formulation of products. Gilteritinib Fumarate API Price is not always fixed or binding as the Gilteritinib Fumarate Price is obtained through a variety of data sources. The Gilteritinib Fumarate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 1254053-84-3 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1254053-84-3, including repackagers and relabelers. The FDA regulates 1254053-84-3 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1254053-84-3 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 1254053-84-3 supplier is an individual or a company that provides 1254053-84-3 active pharmaceutical ingredient (API) or 1254053-84-3 finished formulations upon request. The 1254053-84-3 suppliers may include 1254053-84-3 API manufacturers, exporters, distributors and traders.
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A 1254053-84-3 DMF (Drug Master File) is a document detailing the whole manufacturing process of 1254053-84-3 active pharmaceutical ingredient (API) in detail. Different forms of 1254053-84-3 DMFs exist exist since differing nations have different regulations, such as 1254053-84-3 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1254053-84-3 DMF submitted to regulatory agencies in the US is known as a USDMF. 1254053-84-3 USDMF includes data on 1254053-84-3's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1254053-84-3 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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