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01 2Daiichi Sankyo
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01 1MAAA-1162A
02 1MAAA-1162A (COMMERCIAL)
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01 2Japan
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01 2Active
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01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34021
Submission : 2019-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30003
Submission : 2015-12-09
Status : Active
Type : II
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PharmaCompass offers a list of Deruxtecan 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 Deruxtecan manufacturer or Deruxtecan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Deruxtecan manufacturer or Deruxtecan supplier.
PharmaCompass also assists you with knowing the Deruxtecan API Price utilized in the formulation of products. Deruxtecan API Price is not always fixed or binding as the Deruxtecan Price is obtained through a variety of data sources. The Deruxtecan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Deruxtecan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Deruxtecan, including repackagers and relabelers. The FDA regulates Deruxtecan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Deruxtecan 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 Deruxtecan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Deruxtecan supplier is an individual or a company that provides Deruxtecan active pharmaceutical ingredient (API) or Deruxtecan finished formulations upon request. The Deruxtecan suppliers may include Deruxtecan API manufacturers, exporters, distributors and traders.
click here to find a list of Deruxtecan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Deruxtecan DMF (Drug Master File) is a document detailing the whole manufacturing process of Deruxtecan active pharmaceutical ingredient (API) in detail. Different forms of Deruxtecan DMFs exist exist since differing nations have different regulations, such as Deruxtecan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Deruxtecan DMF submitted to regulatory agencies in the US is known as a USDMF. Deruxtecan USDMF includes data on Deruxtecan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Deruxtecan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Deruxtecan suppliers with USDMF on PharmaCompass.
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