01 1Merck KGaA Darmstadt DE
02 1QUALITY CHEMICALS S.L. Esparreguera ES
01 2Sodium fluoride
01 1Germany
02 1Spain
01 2Valid
Certificate Number : R1-CEP 1997-088 - Rev 04
Status : Valid
Issue Date : 2018-01-11
Type : Chemical
Substance Number : 514
Certificate Number : R1-CEP 2016-103 - Rev 00
Status : Valid
Issue Date : 2022-03-18
Type : Chemical
Substance Number : 514
A Sodium Fluoride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Fluoride, including repackagers and relabelers. The FDA regulates Sodium Fluoride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Fluoride 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 Sodium Fluoride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Fluoride supplier is an individual or a company that provides Sodium Fluoride active pharmaceutical ingredient (API) or Sodium Fluoride finished formulations upon request. The Sodium Fluoride suppliers may include Sodium Fluoride API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Fluoride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Fluoride CEP of the European Pharmacopoeia monograph is often referred to as a Sodium Fluoride Certificate of Suitability (COS). The purpose of a Sodium Fluoride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sodium Fluoride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sodium Fluoride to their clients by showing that a Sodium Fluoride CEP has been issued for it. The manufacturer submits a Sodium Fluoride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sodium Fluoride CEP holder for the record. Additionally, the data presented in the Sodium Fluoride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sodium Fluoride DMF.
A Sodium Fluoride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sodium Fluoride 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 Sodium Fluoride suppliers with CEP (COS) on PharmaCompass.
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