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
25
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A Quartz dust manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Quartz dust, including repackagers and relabelers. The FDA regulates Quartz dust manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Quartz dust 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 Quartz dust supplier is an individual or a company that provides Quartz dust active pharmaceutical ingredient (API) or Quartz dust finished formulations upon request. The Quartz dust suppliers may include Quartz dust API manufacturers, exporters, distributors and traders.
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A Quartz dust CEP of the European Pharmacopoeia monograph is often referred to as a Quartz dust Certificate of Suitability (COS). The purpose of a Quartz dust CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Quartz dust EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Quartz dust to their clients by showing that a Quartz dust CEP has been issued for it. The manufacturer submits a Quartz dust CEP (COS) as part of the market authorization procedure, and it takes on the role of a Quartz dust CEP holder for the record. Additionally, the data presented in the Quartz dust CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Quartz dust DMF.
A Quartz dust CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Quartz dust 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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