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Status : Withdrawn by Holder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