欧洲药典适用性证书数据库
(Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM)
专论编号 物质名称 证书持有人 持有人ORG-ID和LOC-ID 证书编号 发布日期 证书状态 到期续期 证书结束日期 证书类型 上一程序的结束日期 历史数据
程序类型|结论|日期
1998 Nicergoline CHONGQING QIANTAI PHARMA CO., LTD. Chongqing CN 100053648;100094867 CEP 2022-026 - Rev 02 2025/03/19 Valid 23/06/2028 Chemical 2025/03/19 Transfer of holdership|CEP granted|19/03/2025;
Minor revision|CEP granted|23/09/2024;
New application|CEP granted|23/06/2023
888 Ciprofloxacin Hydrochloride UQUIFA MEXICO S.A. DE C.V. Jiutepec MX 100022026;100030736 CEP 2004-174 - Rev 06 2025/03/19 Valid Chemical 2025/03/19 Minor revision|CEP granted|19/03/2025;
Minor revision|CEP granted|20/03/2024;
Notification|Accepted - CEP remains valid|03/02/2023;
Minor revision|CEP granted|26/01/2022;
Notification|CEP granted|04/06/2021;
Minor revision|Accepted - CEP remains valid|08/09/2020
45 Methyldopa TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2010-182 - Rev 05 2025/03/18 Valid Chemical 2025/03/18 Notification|CEP granted|18/03/2025;
Notification|CEP granted|06/06/2024;
Notification|CEP granted|24/03/2022;
Notification|CEP granted|23/11/2021
2604 Ropinirole hydrochloride ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2017-242 - Rev 02 2025/03/18 Valid Chemical 2025/06/02 Notification|Accepted - CEP remains valid|02/06/2025;
Renewal|CEP granted|18/03/2025;
Notification|CEP granted|13/12/2022
1688 Articaine hydrochloride Moehs Iberica S.L. Rubi ES 100029092;100068825 CEP 2010-262 - Rev 02 2025/03/18 Valid Chemical 2025/03/18 Minor revision|CEP granted|18/03/2025;
Minor revision|CEP granted|24/11/2021
38 Levodopa TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 1999-187 - Rev 10 2025/03/18 Valid Chemical 2025/03/18 Notification|CEP granted|18/03/2025;
Notification|Accepted - CEP remains valid|06/09/2024;
Notification|CEP granted|24/03/2022;
Notification|CEP granted|04/02/2022
2641 Dutasteride SWATI SPENTOSE PRIVATE LIMITED Mumbai IN 100021605;100052219 CEP 2022-503 - Rev 00 2025/03/18 Valid 18/03/2030 Chemical 2025/03/18 New application|CEP granted|18/03/2025
1028 Metoprolol tartrate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 1998-074 - Rev 13 2025/03/18 Valid Chemical 2025/03/18 Notification|CEP granted|18/03/2025;
Notification|Accepted - CEP remains valid|27/08/2024;
Minor revision|CEP granted|12/03/2024;
Minor revision|CEP granted|24/08/2023;
Notification|CEP granted|24/03/2022;
Notification|CEP granted|05/01/2022;
Minor revision|Accepted - CEP remains valid|06/10/2020
573 Verapamil hydrochloride TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2006-098 - Rev 04 2025/03/18 Valid Chemical 2025/03/18 Notification|CEP granted|18/03/2025;
Notification|Accepted - CEP remains valid|03/06/2024;
Notification|CEP granted|24/03/2022;
Notification|CEP granted|23/02/2022
2583 Montelukast sodium TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2011-131 - Rev 03 2025/03/17 Valid Chemical 2025/03/17 Notification|CEP granted|17/03/2025;
Monograph revision|Accepted - CEP remains valid|26/11/2024;
Minor revision|CEP granted|24/02/2022;
Minor revision|Accepted - CEP remains valid|06/10/2020
2703 Ciclesonide AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN 100045727;100075371 CEP 2014-090 - Rev 02 2025/03/17 Valid Chemical 2025/03/17 Minor revision|CEP granted|17/03/2025;
Notification|Rejected|30/01/2025;
Notification|CEP granted|27/10/2022;
Renewal|CEP granted|28/06/2021
1248 Norfloxacin, Product code 312008 KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI 100000627;100009540 CEP 2021-140 - Rev 02 2025/03/17 Valid 20/12/2027 Chemical 2025/03/17 Minor revision|CEP granted|17/03/2025;
Minor revision|Accepted - CEP remains valid|31/08/2023;
Minor revision|CEP granted|28/03/2024;
New application|CEP granted|20/12/2022
2416 Pramipexole dihydrochloride monohydrate Boehringer Ingelheim Pharma GmbH & Co. KG Ingelheim Am Rhein DE 100000199;100004370 CEP 2019-186 - Rev 01 2025/03/17 Valid Chemical 2025/03/17 Renewal|CEP granted|17/03/2025;
Minor revision|Accepted - CEP remains valid|31/10/2023;
Notification|Accepted - CEP remains valid|29/09/2020
3046 Pemetrexed disodium 2.5-hydrate FARMHISPANIA S.A. Montmeló ES 100011645;100022190 CEP 2023-233 - Rev 01 2025/03/17 Valid 25/09/2029 Chemical 2025/03/17 Minor revision|CEP granted|17/03/2025;
New application|CEP granted|25/09/2024
2232 Losartan potassium, Process 3 TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2023-006 - Rev 01 2025/03/17 Valid 06/07/2028 Chemical 2025/05/16 Minor revision|Accepted - CEP remains valid|16/05/2025;
Notification|CEP granted|17/03/2025;
New application|CEP granted|06/07/2023
1702 Naproxen sodium TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2007-047 - Rev 06 2025/03/17 Valid Chemical 2025/03/18 Notification|CEP granted|18/03/2025;
Notification|Accepted - CEP remains valid|17/07/2024;
Notification|CEP granted|24/03/2022;
Notification|CEP granted|23/11/2021
1368 Ramipril, Grade A AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN 100045727;100075371 CEP 2009-083 - Rev 06 2025/03/17 Valid Chemical 2025/07/29 Minor revision|Accepted - CEP remains valid|29/07/2025;
Major revision|CEP granted|18/03/2025;
Minor revision|Accepted - CEP remains valid|31/08/2023;
Notification|Rejected|27/07/2023;
Notification|CEP granted|14/10/2022;
Monograph revision|CEP granted|06/12/2021
1592 Ketotifen hydrogen fumarate OLON S.P.A. Rodano IT 100012085;100019537 CEP 2012-054 - Rev 05 2025/03/17 Valid Chemical 2025/03/18 Minor revision|CEP granted|18/03/2025;
Minor revision|CEP granted|29/07/2024;
Minor revision|CEP granted|10/06/2021
1653 Potassium clavulanate, diluted, With silicone dioxide in the ratio 1:1 SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. Linyi CN 100025540;100034769 CEP 2011-376 - Rev 03 2025/03/17 Valid Chemical 2025/03/18 Minor revision|CEP granted|18/03/2025;
Minor revision|Accepted - CEP remains valid|01/03/2024;
Minor revision|Accepted - CEP remains valid|04/10/2022;
Minor revision|CEP granted|01/03/2021;
Minor revision|Accepted - CEP remains valid|13/02/2020
731 Naproxen TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 1997-064 - Rev 09 2025/03/17 Valid Chemical 2025/03/18 Notification|CEP granted|18/03/2025;
Notification|Accepted - CEP remains valid|07/06/2024;
Notification|CEP granted|24/03/2022;
Notification|CEP granted|23/11/2021

数据库说明:

当前数据更新日期:2026年02月03日。
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