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
2600 Olmesartan medoxomil TORRENT PHARMACEUTICALS LIMITED Ahmedabad IN 100004452;100001862 CEP 2023-126 - Rev 00 2026/02/19 Valid 19/02/2031 Chemical 2026/02/19 New application|CEP granted|19/02/2026
1425 Fosfomycin trometamol GUILIN HWASUN PHARMACEUTICAL CO., LTD. Guilin CN 100034192;100054092 CEP 2025-152 - Rev 00 2026/02/19 Valid 19/02/2031 Chemical 2026/02/19 New application|CEP granted|19/02/2026
2857 Trazodone hydrochloride, Process-II, Milled/Unmilled INTAS PHARMACEUTICALS LIMITED Ahmedabad IN 100011529;100023432 CEP 2025-141 - Rev 02 2026/02/19 Valid 13/11/2030 Chemical 2026/02/19 Administrative procedure|CEP granted|19/02/2026;
Minor revision|CEP granted|03/02/2026;
New application|CEP granted|13/11/2025
50 Procaine Hydrochloride FLARER S.A. Balerna CH 100047920;100079248 CEP 2021-223 - Rev 03 2026/02/19 Valid 14/11/2027 Chemical 2026/02/19 Monograph revision|CEP granted|19/02/2026;
Minor revision|Accepted - CEP remains valid|03/12/2025;
Minor revision|CEP granted|24/02/2025;
Minor revision|CEP granted|02/02/2024;
New application|CEP granted|14/11/2022
52 Rifampicin OLON S.P.A. Rodano IT 100012085;100019537 CEP 2009-275 - Rev 06 2026/02/18 Valid Chemical 2026/02/18 Minor revision|CEP granted|18/02/2026;
Minor revision|CEP granted|27/05/2024;
Minor revision|CEP granted|27/07/2022;
Major revision|CEP granted|24/11/2021
1756 Lamotrigine ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2011-010 - Rev 06 2026/02/18 Valid Chemical 2026/02/18 Minor revision|CEP granted|18/02/2026;
Minor revision|CEP granted|03/02/2025;
Minor revision|CEP granted|12/07/2024;
Notification|CEP granted|19/06/2023;
Minor revision|CEP granted|18/02/2022;
Minor revision|CEP granted|06/04/2020
179 Erythromycin, Micronised, powder ERCROS S.A. Aranjuez ES 100016091;100024873 CEP 2003-129 - Rev 03 2026/02/18 Valid Chemical 2026/02/18 Minor revision|CEP granted|18/02/2026;
Major revision|Rejected|04/11/2025;
Monograph revision|CEP granted|26/03/2021
1615 Finasteride SHAKTI LIFESCIENCE PRIVATE LIMITED Mumbai IN 100048889;100089578 CEP 2023-335 - Rev 00 2026/02/18 Valid 18/02/2031 Chemical 2026/02/18 New application|CEP granted|18/02/2026
1275 Ursodeoxycholic acid ZHONGSHAN BELLING BIOTECHNOLOGY CO., LTD. Zhongshan City CN 100039390;100062018 CEP 2018-237 - Rev 02 2026/02/18 Valid Chemical 2026/02/18 Monograph revision|CEP granted|18/02/2026;
Renewal|CEP granted|10/07/2024;
Notification|Accepted - CEP remains valid|26/09/2023
579 Aprotinin concentrated solution, Activity: 100 - 136 Ph. Eur. Units of aprotinin activity per mL Bacterial endotoxin free PENTAPHARM AG Aesch CH 100025404;100052203 CEP 2002-095 - Rev 08 2026/02/18 Valid Chemical and TSE 2026/02/18 Monograph revision|CEP granted|18/02/2026;
Monograph revision|CEP granted|20/03/2025;
Notification|Accepted - CEP remains valid|17/07/2023;
Transfer of holdership|CEP granted|30/06/2023;
Notification|Accepted - CEP remains valid|04/04/2022;
Monograph revision|CEP granted|23/02/2022;
Minor revision|Accepted - CEP remains valid|27/11/2020
3139 Brivaracetam, Non-micronised and micronised ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN 100011833;100018698 CEP 2024-064 - Rev 02 2026/02/18 Valid 25/02/2030 Chemical 2026/02/18 Minor revision|CEP granted|18/02/2026;
Minor revision|CEP granted|04/12/2025;
New application|CEP granted|25/02/2025
2778 Sitagliptin phosphate monohydrate QUIMICA SINTETICA S.A. Alcala De Henares ES 100012121;100019020 CEP 2024-564 - Rev 00 2026/02/18 Valid 18/02/2031 Chemical 2026/02/18 New application|CEP granted|18/02/2026
1449 Mometasone furoate, Micronised and non-micronised BREATHGREEN PHARMACEUTICAL CO. LTD. Zaozhuang CN 100048781;100081153 CEP 2025-361 - Rev 00 2026/02/18 Valid 18/02/2031 Chemical 2026/02/18 New application|CEP granted|18/02/2026
2932 Rivaroxaban DIJIA PHARMACEUTICAL GROUP CO., LTD. Weihai CN 100048717;100100668 CEP 2024-174 - Rev 00 2026/02/18 Valid 18/02/2031 Chemical 2026/02/18 New application|CEP granted|18/02/2026
1909 Sodium polystyrene sulfonate VALENS PHARMACHEM PRIVATE LIMITED Nadiad IN 100052857;100093188 CEP 2025-058 - Rev 00 2026/02/18 Valid 18/02/2031 Chemical 2026/02/18 New application|CEP granted|18/02/2026
572 Timolol maleate TIANJIN MINXIANG PHARMACEUTICAL CO., LTD. Jinghai CN 100034356;100054454 CEP 2024-458 - Rev 00 2026/02/18 Valid 18/02/2031 Chemical 2026/02/18 New application|CEP granted|18/02/2026
2631 Rosuvastatin calcium, Process I BIOCON LIMITED Bengaluru IN 100011487;100018595 CEP 2015-114 - Rev 04 2026/02/16 Valid Chemical 2026/02/16 Minor revision|CEP granted|16/02/2026;
Minor revision|CEP granted|21/10/2024;
Notification|Accepted - CEP remains valid|20/03/2023;
Major revision|CEP granted|27/01/2023;
Major revision|CEP granted|22/02/2022;
Renewal|CEP granted|16/08/2021;
Monograph revision|CEP granted|13/08/2020
2154 Telmisartan, Non-micronised, micronised ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN 100011833;100018698 CEP 2009-077 - Rev 03 2026/02/16 Valid Chemical 2026/02/16 Minor revision|CEP granted|16/02/2026;
Notification|Accepted - CEP remains valid|04/03/2025;
Notification|Accepted - CEP remains valid|12/06/2024;
Minor revision|Accepted - CEP remains valid|05/04/2023;
Notification|Accepted - CEP remains valid|09/06/2022;
Notification|Accepted - CEP remains valid|20/10/2021;
Notification|CEP granted|14/04/2021;
Major revision|Abandoned|23/02/2021;
Minor revision|Accepted - CEP remains valid|23/10/2020
53 Streptomycin sulfate North China Pharmaceutical Huasheng Co., Ltd. Shijiazhuang CN 100021261;100029965 CEP 2001-394 - Rev 04 2026/02/16 Valid Chemical 2026/02/16 Monograph revision|CEP granted|16/02/2026;
Minor revision|Accepted - CEP remains valid|22/07/2024;
Minor revision|CEP granted|29/06/2023;
Minor revision|CEP granted|27/08/2021;
Monograph revision|Accepted - CEP remains valid|12/01/2021
2531 Clopidogrel hydrogen sulfate, Form II, micronised and non-micronised MSN ORGANICS PRIVATE LIMITED Bibinagar Village IN 100012074;100018617 CEP 2015-331 - Rev 01 2026/02/16 Valid Chemical 2026/02/16 Minor revision|CEP granted|16/02/2026;
Minor revision|Accepted - CEP remains valid|11/08/2022;
Renewal|CEP granted|26/01/2022;
Minor revision|CEP granted|01/12/2020

数据库说明:

当前数据更新日期:2026年05月28日。
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