01 1The Dow Chemical Company
01 120% OXYGEN, 80% ARGON
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3275
Submission : 1978-08-15
Status : Inactive
Type : II
A Oxygen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxygen, including repackagers and relabelers. The FDA regulates Oxygen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxygen 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 Oxygen supplier is an individual or a company that provides Oxygen active pharmaceutical ingredient (API) or Oxygen finished formulations upon request. The Oxygen suppliers may include Oxygen API manufacturers, exporters, distributors and traders.
click here to find a list of Oxygen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxygen DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxygen active pharmaceutical ingredient (API) in detail. Different forms of Oxygen DMFs exist exist since differing nations have different regulations, such as Oxygen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxygen DMF submitted to regulatory agencies in the US is known as a USDMF. Oxygen USDMF includes data on Oxygen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxygen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxygen suppliers with USDMF on PharmaCompass.
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