01 1Abbott Laboratories
01 1DICUMAROL
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5641
Submission : 1984-12-20
Status : Inactive
Type : II
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A Dicoumerol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dicoumerol, including repackagers and relabelers. The FDA regulates Dicoumerol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dicoumerol 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 Dicoumerol supplier is an individual or a company that provides Dicoumerol active pharmaceutical ingredient (API) or Dicoumerol finished formulations upon request. The Dicoumerol suppliers may include Dicoumerol API manufacturers, exporters, distributors and traders.
click here to find a list of Dicoumerol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Dicoumerol DMF (Drug Master File) is a document detailing the whole manufacturing process of Dicoumerol active pharmaceutical ingredient (API) in detail. Different forms of Dicoumerol DMFs exist exist since differing nations have different regulations, such as Dicoumerol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dicoumerol DMF submitted to regulatory agencies in the US is known as a USDMF. Dicoumerol USDMF includes data on Dicoumerol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dicoumerol USDMF is kept confidential to protect the manufacturer’s intellectual property.
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