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
60
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A Fine Gum HES manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fine Gum HES, including repackagers and relabelers. The FDA regulates Fine Gum HES manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fine Gum HES 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 Fine Gum HES supplier is an individual or a company that provides Fine Gum HES active pharmaceutical ingredient (API) or Fine Gum HES finished formulations upon request. The Fine Gum HES suppliers may include Fine Gum HES API manufacturers, exporters, distributors and traders.
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A Fine Gum HES CEP of the European Pharmacopoeia monograph is often referred to as a Fine Gum HES Certificate of Suitability (COS). The purpose of a Fine Gum HES CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fine Gum HES EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fine Gum HES to their clients by showing that a Fine Gum HES CEP has been issued for it. The manufacturer submits a Fine Gum HES CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fine Gum HES CEP holder for the record. Additionally, the data presented in the Fine Gum HES CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fine Gum HES DMF.
A Fine Gum HES CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fine Gum HES 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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