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