01 1Mallinckrodt Pharmaceuticals
01 1SODIUM HYDROGEN L-TARTRATE
01 1Ireland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11227
Submission : 1994-12-01
Status : Inactive
Type : II
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PharmaCompass offers a list of Sodium Bitartrate 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 Sodium Bitartrate manufacturer or Sodium Bitartrate supplier for your needs.
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A Sodium Bitartrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Bitartrate, including repackagers and relabelers. The FDA regulates Sodium Bitartrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Bitartrate 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 Sodium Bitartrate supplier is an individual or a company that provides Sodium Bitartrate active pharmaceutical ingredient (API) or Sodium Bitartrate finished formulations upon request. The Sodium Bitartrate suppliers may include Sodium Bitartrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Bitartrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sodium Bitartrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Bitartrate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Bitartrate DMFs exist exist since differing nations have different regulations, such as Sodium Bitartrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Bitartrate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Bitartrate USDMF includes data on Sodium Bitartrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Bitartrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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