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 Aerosil 380 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aerosil 380, including repackagers and relabelers. The FDA regulates Aerosil 380 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aerosil 380 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 Aerosil 380 supplier is an individual or a company that provides Aerosil 380 active pharmaceutical ingredient (API) or Aerosil 380 finished formulations upon request. The Aerosil 380 suppliers may include Aerosil 380 API manufacturers, exporters, distributors and traders.
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A Aerosil 380 CEP of the European Pharmacopoeia monograph is often referred to as a Aerosil 380 Certificate of Suitability (COS). The purpose of a Aerosil 380 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Aerosil 380 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Aerosil 380 to their clients by showing that a Aerosil 380 CEP has been issued for it. The manufacturer submits a Aerosil 380 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Aerosil 380 CEP holder for the record. Additionally, the data presented in the Aerosil 380 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Aerosil 380 DMF.
A Aerosil 380 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Aerosil 380 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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