01 1JUNGBUNZLAUER LADENBURG GMBH Ladenburg DE
01 1Potassium citrate
01 1Switzerland
01 1Valid
Certificate Number : CEP 2011-388 - Rev 03
Status : Valid
Issue Date : 2024-05-15
Type : Chemical
Substance Number : 400
A Potassium Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium Citrate, including repackagers and relabelers. The FDA regulates Potassium Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium Citrate 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 Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Potassium Citrate supplier is an individual or a company that provides Potassium Citrate active pharmaceutical ingredient (API) or Potassium Citrate finished formulations upon request. The Potassium Citrate suppliers may include Potassium Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Potassium Citrate CEP of the European Pharmacopoeia monograph is often referred to as a Potassium Citrate Certificate of Suitability (COS). The purpose of a Potassium Citrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Potassium Citrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Potassium Citrate to their clients by showing that a Potassium Citrate CEP has been issued for it. The manufacturer submits a Potassium Citrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Potassium Citrate CEP holder for the record. Additionally, the data presented in the Potassium Citrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Potassium Citrate DMF.
A Potassium Citrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Potassium Citrate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Potassium Citrate suppliers with CEP (COS) on PharmaCompass.
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