01 1TRUTAG TECHNOLOGIES, INC. Kapolei US
01 1Silica, colloidal anhydrous
01 1U.S.A
01 1Valid
Certificate Number : R0-CEP 2020-282 - Rev 00
Status : Valid
Issue Date : 2022-10-03
Type : Chemical
Substance Number : 434
71
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A Tridimite manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tridimite, including repackagers and relabelers. The FDA regulates Tridimite manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tridimite API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Tridimite supplier is an individual or a company that provides Tridimite active pharmaceutical ingredient (API) or Tridimite finished formulations upon request. The Tridimite suppliers may include Tridimite API manufacturers, exporters, distributors and traders.
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A Tridimite CEP of the European Pharmacopoeia monograph is often referred to as a Tridimite Certificate of Suitability (COS). The purpose of a Tridimite CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tridimite EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tridimite to their clients by showing that a Tridimite CEP has been issued for it. The manufacturer submits a Tridimite CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tridimite CEP holder for the record. Additionally, the data presented in the Tridimite CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tridimite DMF.
A Tridimite CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tridimite 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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