01 1AIR PRODUCTS Saint Quentin Fallavier FR
02 1Air Liquide Paris FR
03 1MESSER FRANCE Suresnes FR
04 2SOL S.P.A. Monza IT
01 4Nitrogen
02 1Nitrogen, low-oxygen
01 2France
02 2Italy
03 1U.S.A
01 5Valid
Certificate Number : R1-CEP 2004-180 - Rev 00
Status : Valid
Issue Date : 2010-06-25
Type : Chemical
Substance Number : 1247
Certificate Number : R1-CEP 2007-041 - Rev 02
Status : Valid
Issue Date : 2019-07-31
Type : Chemical
Substance Number : 1247
Certificate Number : R1-CEP 2010-017 - Rev 00
Status : Valid
Issue Date : 2016-09-21
Type : Chemical
Substance Number : 1247
Certificate Number : R1-CEP 2014-311 - Rev 00
Status : Valid
Issue Date : 2021-03-10
Type : Chemical
Substance Number : 1685
Certificate Number : R1-CEP 2014-312 - Rev 00
Status : Valid
Issue Date : 2021-03-10
Type : Chemical
Substance Number : 1247
A Nitrogen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitrogen, including repackagers and relabelers. The FDA regulates Nitrogen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitrogen 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 Nitrogen supplier is an individual or a company that provides Nitrogen active pharmaceutical ingredient (API) or Nitrogen finished formulations upon request. The Nitrogen suppliers may include Nitrogen API manufacturers, exporters, distributors and traders.
click here to find a list of Nitrogen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nitrogen CEP of the European Pharmacopoeia monograph is often referred to as a Nitrogen Certificate of Suitability (COS). The purpose of a Nitrogen CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nitrogen EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nitrogen to their clients by showing that a Nitrogen CEP has been issued for it. The manufacturer submits a Nitrogen CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nitrogen CEP holder for the record. Additionally, the data presented in the Nitrogen CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nitrogen DMF.
A Nitrogen CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nitrogen 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 Nitrogen suppliers with CEP (COS) on PharmaCompass.
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