01 2Daiichi Sankyo
01 1CS-917 DRUG PRODUCT
02 1CS-917 DRUG SUBSTANCE
01 2Japan
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16550
Submission : 2003-04-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16543
Submission : 2003-04-22
Status : Inactive
Type : II
A Managlinat Dialanetil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Managlinat Dialanetil, including repackagers and relabelers. The FDA regulates Managlinat Dialanetil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Managlinat Dialanetil 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 Managlinat Dialanetil supplier is an individual or a company that provides Managlinat Dialanetil active pharmaceutical ingredient (API) or Managlinat Dialanetil finished formulations upon request. The Managlinat Dialanetil suppliers may include Managlinat Dialanetil API manufacturers, exporters, distributors and traders.
click here to find a list of Managlinat Dialanetil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Managlinat Dialanetil DMF (Drug Master File) is a document detailing the whole manufacturing process of Managlinat Dialanetil active pharmaceutical ingredient (API) in detail. Different forms of Managlinat Dialanetil DMFs exist exist since differing nations have different regulations, such as Managlinat Dialanetil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Managlinat Dialanetil DMF submitted to regulatory agencies in the US is known as a USDMF. Managlinat Dialanetil USDMF includes data on Managlinat Dialanetil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Managlinat Dialanetil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Managlinat Dialanetil suppliers with USDMF on PharmaCompass.
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