01 1Merck KGaA Darmstadt DE
01 1Potassium iodide
01 1Germany
01 1Valid
Certificate Number : R1-CEP 2007-337 - Rev 02
Status : Valid
Issue Date : 2020-05-27
Type : Chemical
Substance Number : 186
A Potassium Iodide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium Iodide, including repackagers and relabelers. The FDA regulates Potassium Iodide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium Iodide 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 Iodide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Potassium Iodide supplier is an individual or a company that provides Potassium Iodide active pharmaceutical ingredient (API) or Potassium Iodide finished formulations upon request. The Potassium Iodide suppliers may include Potassium Iodide API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium Iodide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Potassium Iodide CEP of the European Pharmacopoeia monograph is often referred to as a Potassium Iodide Certificate of Suitability (COS). The purpose of a Potassium Iodide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Potassium Iodide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Potassium Iodide to their clients by showing that a Potassium Iodide CEP has been issued for it. The manufacturer submits a Potassium Iodide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Potassium Iodide CEP holder for the record. Additionally, the data presented in the Potassium Iodide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Potassium Iodide DMF.
A Potassium Iodide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Potassium Iodide 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 Iodide suppliers with CEP (COS) on PharmaCompass.
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