01 1Chemische Fabrik Berg GmbH Bitterfeld-Wolfen DE
02 1SANDOZ GMBH Kundl AT
01 2Thiopental Sodium And Sodium Carbonate, Sterile
01 2Germany
01 1Valid
02 1Withdrawn by Holder
Thiopental Sodium And Sodium Carbonate, Sterile
Certificate Number : R1-CEP 2007-181 - Rev 03
Status : Valid
Issue Date : 2023-06-02
Type : Chemical
Substance Number : 212
Thiopental Sodium And Sodium Carbonate, Sterile
Certificate Number : R1-CEP 1998-028 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2010-02-22
Type : Chemical
Substance Number : 212
67
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A 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium, including repackagers and relabelers. The FDA regulates 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium 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 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium supplier is an individual or a company that provides 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium active pharmaceutical ingredient (API) or 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium finished formulations upon request. The 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium suppliers may include 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium API manufacturers, exporters, distributors and traders.
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A 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium CEP of the European Pharmacopoeia monograph is often referred to as a 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium Certificate of Suitability (COS). The purpose of a 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium to their clients by showing that a 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium CEP has been issued for it. The manufacturer submits a 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium CEP holder for the record. Additionally, the data presented in the 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium DMF.
A 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium 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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