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