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