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Status : Withdrawn by Holder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 Cefalotin sodium Sterile manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefalotin sodium Sterile, including repackagers and relabelers. The FDA regulates Cefalotin sodium Sterile manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefalotin sodium Sterile API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Cefalotin sodium Sterile supplier is an individual or a company that provides Cefalotin sodium Sterile active pharmaceutical ingredient (API) or Cefalotin sodium Sterile finished formulations upon request. The Cefalotin sodium Sterile suppliers may include Cefalotin sodium Sterile API manufacturers, exporters, distributors and traders.
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A Cefalotin sodium Sterile CEP of the European Pharmacopoeia monograph is often referred to as a Cefalotin sodium Sterile Certificate of Suitability (COS). The purpose of a Cefalotin sodium Sterile CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cefalotin sodium Sterile EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cefalotin sodium Sterile to their clients by showing that a Cefalotin sodium Sterile CEP has been issued for it. The manufacturer submits a Cefalotin sodium Sterile CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cefalotin sodium Sterile CEP holder for the record. Additionally, the data presented in the Cefalotin sodium Sterile CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cefalotin sodium Sterile DMF.
A Cefalotin sodium Sterile CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cefalotin sodium Sterile 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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