01 1AIR LIQUIDE HEALTHCARE ESPAÑA, S.L. Madrid ES
02 1AIR PRODUCTS Saint Quentin Fallavier FR
03 1LINDE GMBH Pullach DE
04 3SOL S.P.A. Monza IT
01 4Oxygen
02 1Oxygen, Mantova site
03 1Oxygen, Verona site
01 1France
02 3Italy
03 2U.S.A
01 6Valid
Certificate Number : CEP 2023-357 - Rev 00
Status : Valid
Issue Date : 2024-07-01
Type : Chemical
Substance Number : 417
Certificate Number : R1-CEP 2009-404 - Rev 00
Status : Valid
Issue Date : 2016-07-13
Type : Chemical
Substance Number : 417
Certificate Number : CEP 2019-005 - Rev 05
Status : Valid
Issue Date : 2024-06-05
Type : Chemical
Substance Number : 417
Certificate Number : CEP 2023-184 - Rev 00
Status : Valid
Issue Date : 2024-03-05
Type : Chemical
Substance Number : 417
Certificate Number : CEP 2023-162 - Rev 00
Status : Valid
Issue Date : 2024-03-06
Type : Chemical
Substance Number : 417
Certificate Number : R0-CEP 2020-295 - Rev 00
Status : Valid
Issue Date : 2021-05-10
Type : Chemical
Substance Number : 417
A Oxygen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxygen, including repackagers and relabelers. The FDA regulates Oxygen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxygen 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 Oxygen supplier is an individual or a company that provides Oxygen active pharmaceutical ingredient (API) or Oxygen finished formulations upon request. The Oxygen suppliers may include Oxygen API manufacturers, exporters, distributors and traders.
click here to find a list of Oxygen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxygen CEP of the European Pharmacopoeia monograph is often referred to as a Oxygen Certificate of Suitability (COS). The purpose of a Oxygen CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oxygen EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oxygen to their clients by showing that a Oxygen CEP has been issued for it. The manufacturer submits a Oxygen CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oxygen CEP holder for the record. Additionally, the data presented in the Oxygen CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oxygen DMF.
A Oxygen CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oxygen 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 Oxygen suppliers with CEP (COS) on PharmaCompass.
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