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