01 2Mingtai Chemical Co., Ltd. Taoyuan Hsien TW
01 1Croscarmellose sodium
02 1Croscarmellose sodium, Process II
01 2China
01 2Valid
Croscarmellose Sodium, Process II
Certificate Number : R1-CEP 2012-141 - Rev 00
Status : Valid
Issue Date : 2019-09-18
Type : Chemical
Substance Number : 985
Certificate Number : R1-CEP 2002-250 - Rev 00
Status : Valid
Issue Date : 2010-02-24
Type : Chemical
Substance Number : 985
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A Avicel RC/CL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Avicel RC/CL, including repackagers and relabelers. The FDA regulates Avicel RC/CL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Avicel RC/CL 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 Avicel RC/CL supplier is an individual or a company that provides Avicel RC/CL active pharmaceutical ingredient (API) or Avicel RC/CL finished formulations upon request. The Avicel RC/CL suppliers may include Avicel RC/CL API manufacturers, exporters, distributors and traders.
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A Avicel RC/CL CEP of the European Pharmacopoeia monograph is often referred to as a Avicel RC/CL Certificate of Suitability (COS). The purpose of a Avicel RC/CL CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Avicel RC/CL EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Avicel RC/CL to their clients by showing that a Avicel RC/CL CEP has been issued for it. The manufacturer submits a Avicel RC/CL CEP (COS) as part of the market authorization procedure, and it takes on the role of a Avicel RC/CL CEP holder for the record. Additionally, the data presented in the Avicel RC/CL CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Avicel RC/CL DMF.
A Avicel RC/CL CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Avicel RC/CL 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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