01 1ABBOTT MEDICAL St. Paul US
01 1Glutaraldehyde fixed bovine pericardium
01 1China
01 1Valid
Glutaraldehyde Fixed Bovine Pericardium
Certificate Number : CEP 2015-381 - Rev 02
Status : Valid
Issue Date : 2024-08-20
Type : TSE
Substance Number :
40
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A Pentane-1,5-dial manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentane-1,5-dial, including repackagers and relabelers. The FDA regulates Pentane-1,5-dial manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentane-1,5-dial 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 Pentane-1,5-dial supplier is an individual or a company that provides Pentane-1,5-dial active pharmaceutical ingredient (API) or Pentane-1,5-dial finished formulations upon request. The Pentane-1,5-dial suppliers may include Pentane-1,5-dial API manufacturers, exporters, distributors and traders.
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A Pentane-1,5-dial CEP of the European Pharmacopoeia monograph is often referred to as a Pentane-1,5-dial Certificate of Suitability (COS). The purpose of a Pentane-1,5-dial CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pentane-1,5-dial EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pentane-1,5-dial to their clients by showing that a Pentane-1,5-dial CEP has been issued for it. The manufacturer submits a Pentane-1,5-dial CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pentane-1,5-dial CEP holder for the record. Additionally, the data presented in the Pentane-1,5-dial CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pentane-1,5-dial DMF.
A Pentane-1,5-dial CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pentane-1,5-dial 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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