01 1Jost Chemical
01 1POTASSIUM GLUCONATE ANHYDROUS
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28845
Submission : 2014-11-17
Status : Active
Type : II
A Potassium Gluconate API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium Gluconate API, including repackagers and relabelers. The FDA regulates Potassium Gluconate API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium Gluconate API 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 Gluconate API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Potassium Gluconate API supplier is an individual or a company that provides Potassium Gluconate API active pharmaceutical ingredient (API) or Potassium Gluconate API finished formulations upon request. The Potassium Gluconate API suppliers may include Potassium Gluconate API API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium Gluconate API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Potassium Gluconate API DMF (Drug Master File) is a document detailing the whole manufacturing process of Potassium Gluconate API active pharmaceutical ingredient (API) in detail. Different forms of Potassium Gluconate API DMFs exist exist since differing nations have different regulations, such as Potassium Gluconate API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Potassium Gluconate API DMF submitted to regulatory agencies in the US is known as a USDMF. Potassium Gluconate API USDMF includes data on Potassium Gluconate API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Potassium Gluconate API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Potassium Gluconate API suppliers with USDMF on PharmaCompass.
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