01 1FRESENIUS KABI IPSUM S.R.L. Cassina de’Pecchi IT
01 1Cefalotin sodium, Sterile
01 1Germany
01 1Withdrawn by Holder
Certificate Number : R1-CEP 2004-227 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2019-04-24
Type : Chemical
Substance Number : 987
67
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A Keflin N Injektionsflaschen CEP of the European Pharmacopoeia monograph is often referred to as a Keflin N Injektionsflaschen Certificate of Suitability (COS). The purpose of a Keflin N Injektionsflaschen CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Keflin N Injektionsflaschen EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Keflin N Injektionsflaschen to their clients by showing that a Keflin N Injektionsflaschen CEP has been issued for it. The manufacturer submits a Keflin N Injektionsflaschen CEP (COS) as part of the market authorization procedure, and it takes on the role of a Keflin N Injektionsflaschen CEP holder for the record. Additionally, the data presented in the Keflin N Injektionsflaschen CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Keflin N Injektionsflaschen DMF.
A Keflin N Injektionsflaschen CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Keflin N Injektionsflaschen 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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