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
65
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A UN1690 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of UN1690, including repackagers and relabelers. The FDA regulates UN1690 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. UN1690 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 UN1690 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A UN1690 supplier is an individual or a company that provides UN1690 active pharmaceutical ingredient (API) or UN1690 finished formulations upon request. The UN1690 suppliers may include UN1690 API manufacturers, exporters, distributors and traders.
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A UN1690 CEP of the European Pharmacopoeia monograph is often referred to as a UN1690 Certificate of Suitability (COS). The purpose of a UN1690 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of UN1690 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of UN1690 to their clients by showing that a UN1690 CEP has been issued for it. The manufacturer submits a UN1690 CEP (COS) as part of the market authorization procedure, and it takes on the role of a UN1690 CEP holder for the record. Additionally, the data presented in the UN1690 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the UN1690 DMF.
A UN1690 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. UN1690 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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