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