01 1Zhejiang Charioteer Pharmaceutical Co., Ltd. Xianju CN
01 1Ganciclovir
01 1China
01 1Valid
Certificate Number : R1-CEP 2013-123 - Rev 01
Status : Valid
Issue Date : 2019-06-20
Type : Chemical
Substance Number : 1752
17
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A Cymevan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cymevan, including repackagers and relabelers. The FDA regulates Cymevan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cymevan 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 Cymevan supplier is an individual or a company that provides Cymevan active pharmaceutical ingredient (API) or Cymevan finished formulations upon request. The Cymevan suppliers may include Cymevan API manufacturers, exporters, distributors and traders.
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A Cymevan CEP of the European Pharmacopoeia monograph is often referred to as a Cymevan Certificate of Suitability (COS). The purpose of a Cymevan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cymevan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cymevan to their clients by showing that a Cymevan CEP has been issued for it. The manufacturer submits a Cymevan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cymevan CEP holder for the record. Additionally, the data presented in the Cymevan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cymevan DMF.
A Cymevan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cymevan 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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