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
25
PharmaCompass offers a list of Deuterium Oxide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Deuterium Oxide manufacturer or Deuterium Oxide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Deuterium Oxide manufacturer or Deuterium Oxide supplier.
A D2O manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of D2O, including repackagers and relabelers. The FDA regulates D2O manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. D2O 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 D2O supplier is an individual or a company that provides D2O active pharmaceutical ingredient (API) or D2O finished formulations upon request. The D2O suppliers may include D2O API manufacturers, exporters, distributors and traders.
click here to find a list of D2O suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A D2O DMF (Drug Master File) is a document detailing the whole manufacturing process of D2O active pharmaceutical ingredient (API) in detail. Different forms of D2O DMFs exist exist since differing nations have different regulations, such as D2O USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A D2O DMF submitted to regulatory agencies in the US is known as a USDMF. D2O USDMF includes data on D2O's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The D2O USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of D2O suppliers with USDMF on PharmaCompass.
