01 1SIGMA TAU
01 1DEUTERIUM OXIDE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4064
Submission : 1981-02-02
Status : Inactive
Type : II
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A Deuterium Oxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Deuterium Oxide, including repackagers and relabelers. The FDA regulates Deuterium Oxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Deuterium Oxide 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 Deuterium Oxide supplier is an individual or a company that provides Deuterium Oxide active pharmaceutical ingredient (API) or Deuterium Oxide finished formulations upon request. The Deuterium Oxide suppliers may include Deuterium Oxide API manufacturers, exporters, distributors and traders.
click here to find a list of Deuterium Oxide suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Deuterium Oxide DMF (Drug Master File) is a document detailing the whole manufacturing process of Deuterium Oxide active pharmaceutical ingredient (API) in detail. Different forms of Deuterium Oxide DMFs exist exist since differing nations have different regulations, such as Deuterium Oxide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Deuterium Oxide DMF submitted to regulatory agencies in the US is known as a USDMF. Deuterium Oxide USDMF includes data on Deuterium Oxide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Deuterium Oxide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Deuterium Oxide suppliers with USDMF on PharmaCompass.
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