01 1BAYER AG Leverkusen DE
02 1GEDEON RICHTER PLC Budapest HU
03 1Hubei Gedian Humanwell Pharmaceutical Co., Ltd. E-Zhou CN
04 1Industriale Chimica S.R.L. Saronno IT
05 1Jenapharm GmbH & Co KG Jena DE
06 1LUPIN LIMITED Mumbai IN
07 3QINHUANGDAO ZIZHU PHARMACEUTICAL CO., LTD. Qinhuangdao City CN
08 2STERLING CHEMICAL MALTA LTD. Birzebbugia MT
01 6Levonorgestrel
02 1Levonorgestrel, Micro 20
03 1Levonorgestrel, Micronised
04 1Levonorgestrel, Micronised, Process II
05 1Levonorgestrel, Micronised, code 200318
06 1Levonorgestrel, Non-micronised and micronised
01 4China
02 2Germany
03 1Hungary
04 1India
05 3Italy
01 9Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 1Withdrawn by Holder
Certificate Number : R1-CEP 2000-101 - Rev 03
Status : Valid
Issue Date : 2017-03-03
Type : Chemical
Substance Number : 926
Certificate Number : R1-CEP 1999-141 - Rev 04
Status : Valid
Issue Date : 2021-12-20
Type : Chemical
Substance Number : 926
Levonorgestrel, Non-micronised And Micronised
Certificate Number : R0-CEP 2022-199 - Rev 00
Status : Valid
Issue Date : 2023-05-19
Type : Chemical
Substance Number : 926
Certificate Number : CEP 2003-127 - Rev 03
Status : Valid
Issue Date : 2024-08-01
Type : Chemical
Substance Number : 926
Certificate Number : CEP 2012-349 - Rev 01
Status : Valid
Issue Date : 2024-09-13
Type : Chemical
Substance Number : 926
Levonorgestrel, Micronised, Process II
Certificate Number : R0-CEP 2022-225 - Rev 00
Status : Valid
Issue Date : 2022-12-20
Type : Chemical
Substance Number : 926
Certificate Number : R1-CEP 2013-237 - Rev 00
Status : Valid
Issue Date : 2019-04-30
Type : Chemical
Substance Number : 926
Certificate Number : R1-CEP 2006-218 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2014-02-27
Type : Chemical
Substance Number : 926
Levonorgestrel, Micronised, Code 200318
Certificate Number : R0-CEP 2021-255 - Rev 01
Status : Valid
Issue Date : 2023-06-16
Type : Chemical
Substance Number : 926
Certificate Number : R1-CEP 2015-056 - Rev 00
Status : Valid
Issue Date : 2023-02-07
Type : Chemical
Substance Number : 926
61
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A Trinordiol 21 CEP of the European Pharmacopoeia monograph is often referred to as a Trinordiol 21 Certificate of Suitability (COS). The purpose of a Trinordiol 21 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Trinordiol 21 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Trinordiol 21 to their clients by showing that a Trinordiol 21 CEP has been issued for it. The manufacturer submits a Trinordiol 21 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Trinordiol 21 CEP holder for the record. Additionally, the data presented in the Trinordiol 21 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Trinordiol 21 DMF.
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