01 2Fresenius Kabi Austria GmbH Linz AT
02 2SERUMWERK BERNBURG AG Bernburg DE
01 1Starches, hydroxyethyl, Mw 130, MS 0.42, C2/C6 6
02 2Starches, hydroxyethyl, Mw 200, MS 0.5, C2/C6 6
03 1Starches, hydroxyethyl, Mw 450, MS 0.7, C2/C6 5
01 2Austria
02 2Germany
01 4Valid
Starches, Hydroxyethyl, Mw 200, MS 0.5, C2/C6 6
Certificate Number : R1-CEP 2010-242 - Rev 00
Status : Valid
Issue Date : 2017-06-29
Type : Chemical
Substance Number : 1785
Starches, Hydroxyethyl, Mw 450, MS 0.7, C2/C6 5
Certificate Number : R1-CEP 2010-284 - Rev 00
Status : Valid
Issue Date : 2017-06-29
Type : Chemical
Substance Number : 1785
Starches, Hydroxyethyl, Mw 130, MS 0.42, C2/C6 6
Certificate Number : R1-CEP 2013-234 - Rev 00
Status : Valid
Issue Date : 2019-06-21
Type : Chemical
Substance Number : 1785
Starches, Hydroxyethyl, Mw 200, MS 0.5, C2/C6 6
Certificate Number : R1-CEP 2014-281 - Rev 00
Status : Valid
Issue Date : 2020-03-26
Type : Chemical
Substance Number : 1785
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A Remyline Ac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Remyline Ac, including repackagers and relabelers. The FDA regulates Remyline Ac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Remyline Ac 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 Remyline Ac CEP of the European Pharmacopoeia monograph is often referred to as a Remyline Ac Certificate of Suitability (COS). The purpose of a Remyline Ac CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Remyline Ac EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Remyline Ac to their clients by showing that a Remyline Ac CEP has been issued for it. The manufacturer submits a Remyline Ac CEP (COS) as part of the market authorization procedure, and it takes on the role of a Remyline Ac CEP holder for the record. Additionally, the data presented in the Remyline Ac CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Remyline Ac DMF.
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