01 1LINDE HEALTHCARE AB Solna SE
02 1SOL S.P.A. Monza IT
01 2Nitric oxide
01 1Italy
02 1U.S.A
01 2Valid
Certificate Number : R1-CEP 2016-217 - Rev 00
Status : Valid
Issue Date : 2022-09-09
Type : Chemical
Substance Number : 1550
Certificate Number : R1-CEP 2014-103 - Rev 00
Status : Valid
Issue Date : 2020-05-26
Type : Chemical
Substance Number : 1550
A Nitric Oxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitric Oxide, including repackagers and relabelers. The FDA regulates Nitric Oxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitric Oxide 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 Nitric Oxide supplier is an individual or a company that provides Nitric Oxide active pharmaceutical ingredient (API) or Nitric Oxide finished formulations upon request. The Nitric Oxide suppliers may include Nitric Oxide API manufacturers, exporters, distributors and traders.
click here to find a list of Nitric Oxide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nitric Oxide CEP of the European Pharmacopoeia monograph is often referred to as a Nitric Oxide Certificate of Suitability (COS). The purpose of a Nitric Oxide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nitric Oxide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nitric Oxide to their clients by showing that a Nitric Oxide CEP has been issued for it. The manufacturer submits a Nitric Oxide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nitric Oxide CEP holder for the record. Additionally, the data presented in the Nitric Oxide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nitric Oxide DMF.
A Nitric Oxide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nitric Oxide 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 Nitric Oxide suppliers with CEP (COS) on PharmaCompass.
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