01 1The Dow Chemical Company
01 1VERSENE NA CHELATING AGENT
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11287
Submission : 1994-12-29
Status : Inactive
Type : II
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PharmaCompass offers a list of Edetate Sodium 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 Edetate Sodium manufacturer or Edetate Sodium supplier for your needs.
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A Na4EDTA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Na4EDTA, including repackagers and relabelers. The FDA regulates Na4EDTA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Na4EDTA 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 Na4EDTA supplier is an individual or a company that provides Na4EDTA active pharmaceutical ingredient (API) or Na4EDTA finished formulations upon request. The Na4EDTA suppliers may include Na4EDTA API manufacturers, exporters, distributors and traders.
click here to find a list of Na4EDTA suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Na4EDTA DMF (Drug Master File) is a document detailing the whole manufacturing process of Na4EDTA active pharmaceutical ingredient (API) in detail. Different forms of Na4EDTA DMFs exist exist since differing nations have different regulations, such as Na4EDTA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Na4EDTA DMF submitted to regulatory agencies in the US is known as a USDMF. Na4EDTA USDMF includes data on Na4EDTA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Na4EDTA USDMF is kept confidential to protect the manufacturer’s intellectual property.
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