01 2CSPC INNOVATION PHARMACEUTICAL CO., LTD. Shijiazhuang City CN
01 2Theobromine - Text Deleted 1/07/2021
01 2China
01 1Expired
02 1Withdrawn by EDQM Failure to CEP procedure
Theobromine - Text Deleted 1/07/2021
Certificate Number : R0-CEP 2010-168 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2011-07-27
Type : Chemical
Substance Number :
Theobromine - Text Deleted 1/07/2021
Certificate Number : R0-CEP 2014-228 - Rev 00
Status : Expired
Issue Date : 2016-05-20
Type : Chemical
Substance Number :
76
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A CAS-83-67-0 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-83-67-0, including repackagers and relabelers. The FDA regulates CAS-83-67-0 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-83-67-0 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 CAS-83-67-0 supplier is an individual or a company that provides CAS-83-67-0 active pharmaceutical ingredient (API) or CAS-83-67-0 finished formulations upon request. The CAS-83-67-0 suppliers may include CAS-83-67-0 API manufacturers, exporters, distributors and traders.
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A CAS-83-67-0 CEP of the European Pharmacopoeia monograph is often referred to as a CAS-83-67-0 Certificate of Suitability (COS). The purpose of a CAS-83-67-0 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of CAS-83-67-0 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of CAS-83-67-0 to their clients by showing that a CAS-83-67-0 CEP has been issued for it. The manufacturer submits a CAS-83-67-0 CEP (COS) as part of the market authorization procedure, and it takes on the role of a CAS-83-67-0 CEP holder for the record. Additionally, the data presented in the CAS-83-67-0 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the CAS-83-67-0 DMF.
A CAS-83-67-0 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. CAS-83-67-0 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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