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01 1POTASSIUM BICARBONATE, USP
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6403
Submission : 1986-06-02
Status : Inactive
Type : II
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A Potassium hydrogen carbonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium hydrogen carbonate, including repackagers and relabelers. The FDA regulates Potassium hydrogen carbonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium hydrogen carbonate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Potassium hydrogen carbonate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Potassium hydrogen carbonate supplier is an individual or a company that provides Potassium hydrogen carbonate active pharmaceutical ingredient (API) or Potassium hydrogen carbonate finished formulations upon request. The Potassium hydrogen carbonate suppliers may include Potassium hydrogen carbonate API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium hydrogen carbonate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Potassium hydrogen carbonate DMF (Drug Master File) is a document detailing the whole manufacturing process of Potassium hydrogen carbonate active pharmaceutical ingredient (API) in detail. Different forms of Potassium hydrogen carbonate DMFs exist exist since differing nations have different regulations, such as Potassium hydrogen carbonate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Potassium hydrogen carbonate DMF submitted to regulatory agencies in the US is known as a USDMF. Potassium hydrogen carbonate USDMF includes data on Potassium hydrogen carbonate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Potassium hydrogen carbonate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Potassium hydrogen carbonate suppliers with USDMF on PharmaCompass.
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