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