01 1MESSER FRANCE Suresnes FR
02 1S.E. DE CARBUROS METALICOS, S.A. Cornellà de Llobregat ES
01 2Carbon dioxide
01 1France
02 1Spain
01 1Valid
02 1Withdrawn by Holder
Certificate Number : R1-CEP 2009-393 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2016-09-27
Type : Chemical
Substance Number : 375
Certificate Number : R0-CEP 2019-254 - Rev 00
Status : Valid
Issue Date : 2021-04-14
Type : Chemical
Substance Number : 375
A Carbon Dioxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carbon Dioxide, including repackagers and relabelers. The FDA regulates Carbon Dioxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carbon Dioxide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Carbon Dioxide supplier is an individual or a company that provides Carbon Dioxide active pharmaceutical ingredient (API) or Carbon Dioxide finished formulations upon request. The Carbon Dioxide suppliers may include Carbon Dioxide API manufacturers, exporters, distributors and traders.
click here to find a list of Carbon Dioxide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Carbon Dioxide CEP of the European Pharmacopoeia monograph is often referred to as a Carbon Dioxide Certificate of Suitability (COS). The purpose of a Carbon Dioxide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Carbon Dioxide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Carbon Dioxide to their clients by showing that a Carbon Dioxide CEP has been issued for it. The manufacturer submits a Carbon Dioxide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Carbon Dioxide CEP holder for the record. Additionally, the data presented in the Carbon Dioxide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Carbon Dioxide DMF.
A Carbon Dioxide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Carbon Dioxide CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Carbon Dioxide suppliers with CEP (COS) on PharmaCompass.
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