01 1VITAL LABORATORIES PVT. LIMITED Mumbai IN
01 1Reserpine
01 1India
01 1Withdrawn by EDQM Failure to CEP procedure
Certificate Number : R0-CEP 2010-041 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2011-11-29
Type : Chemical
Substance Number : 528
95
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A Hydrosine 25 CEP of the European Pharmacopoeia monograph is often referred to as a Hydrosine 25 Certificate of Suitability (COS). The purpose of a Hydrosine 25 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hydrosine 25 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hydrosine 25 to their clients by showing that a Hydrosine 25 CEP has been issued for it. The manufacturer submits a Hydrosine 25 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hydrosine 25 CEP holder for the record. Additionally, the data presented in the Hydrosine 25 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hydrosine 25 DMF.
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