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