01 1Merck KGaA Darmstadt DE
01 1Dipotassium phosphate
01 1Germany
01 1Valid
Certificate Number : R1-CEP 2014-307 - Rev 00
Status : Valid
Issue Date : 2020-12-10
Type : Chemical
Substance Number : 1003
A Potassium Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium Phosphate, including repackagers and relabelers. The FDA regulates Potassium Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium Phosphate 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 Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Potassium Phosphate supplier is an individual or a company that provides Potassium Phosphate active pharmaceutical ingredient (API) or Potassium Phosphate finished formulations upon request. The Potassium Phosphate suppliers may include Potassium Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Potassium Phosphate CEP of the European Pharmacopoeia monograph is often referred to as a Potassium Phosphate Certificate of Suitability (COS). The purpose of a Potassium Phosphate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Potassium Phosphate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Potassium Phosphate to their clients by showing that a Potassium Phosphate CEP has been issued for it. The manufacturer submits a Potassium Phosphate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Potassium Phosphate CEP holder for the record. Additionally, the data presented in the Potassium Phosphate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Potassium Phosphate DMF.
A Potassium Phosphate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Potassium Phosphate 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 Phosphate suppliers with CEP (COS) on PharmaCompass.
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