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
1169 Piperacillin monohydrate, Process III SHANDONG ANSHUN PHARMACEUTICAL CO., LTD. Dezhou CN 100039958;100064554 CEP 2025-549 - Rev 00 2026/03/04 Valid 04/03/2031 Chemical 2026/03/04 New application|CEP granted|04/03/2026
890 Clonazepam LAKE CHEMICALS PRIVATE LIMITED Bengaluru IN 100012055;100053935 CEP 2009-101 - Rev 02 2026/03/04 Valid Chemical 2026/03/04 Monograph revision|CEP granted|04/03/2026;
Minor revision|CEP granted|10/08/2023
3039 Dronedarone hydrochloride, Crystalline, micronised and non-micronised MSN LABORATORIES PRIVATE LIMITED Sangareddy IN 100011732;100018657 CEP 2020-033 - Rev 01 2026/03/04 Valid 09/08/2027 Chemical 2026/03/04 Minor revision|CEP granted|04/03/2026;
New application|CEP granted|09/08/2022
2235 Methylphenidate hydrochloride VERANOVA, L.P. West Deptford US 100012273;100018937 CEP 2017-119 - Rev 02 2026/03/03 Valid Chemical 2026/03/03 Minor revision|CEP granted|03/03/2026;
Minor revision|CEP granted|14/10/2024;
Minor revision|Accepted - CEP remains valid|25/04/2023;
Renewal|CEP granted|22/02/2023;
Minor revision|Accepted - CEP remains valid|08/06/2022
2296 Pantoprazole sodium sesquihydrate NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100089573 CEP 2012-205 - Rev 02 2026/03/03 Valid Chemical 2026/03/03 Notification|CEP granted|03/03/2026;
Minor revision|CEP granted|09/04/2024;
Notification|Rejected|22/02/2024
2219 Lansoprazole NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100089573 CEP 2010-309 - Rev 03 2026/03/03 Valid Chemical 2026/03/03 Notification|CEP granted|03/03/2026;
Minor revision|CEP granted|18/12/2024;
Notification|CEP granted|06/08/2021
2858 Mometasone furoate monohydrate, Micronised STERLING S.p.A. Corciano IT 100024377;100033551 CEP 2025-557 - Rev 00 2026/03/03 Valid 03/03/2031 Chemical 2026/03/03 New application|CEP granted|03/03/2026
2132 Torasemide MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2021-167 - Rev 01 2026/03/03 Valid 10/10/2027 Chemical 2026/03/03 Major revision|CEP granted|03/03/2026;
New application|CEP granted|10/10/2022
627 Nifedipine MOEHS IBERICA S.L. Rubi ES 100029092;100068825 CEP 1996-105 - Rev 06 2026/03/03 Valid Chemical 2026/03/03 Monograph revision|CEP granted|03/03/2026;
Minor revision|CEP granted|22/04/2024
718 Glibenclamide, Non-micronised, micronised USV PRIVATE LIMITED Mumbai IN 100006251;100010851 CEP 2000-090 - Rev 06 2026/03/02 Valid Chemical 2026/03/02 Minor revision|CEP granted|02/03/2026;
Minor revision|CEP granted|19/04/2024;
Notification|Rejected|22/01/2024
2331 Rabeprazole sodium hydrate, Form-Y (RBL process) DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2020-382 - Rev 01 2026/03/02 Valid Chemical 2026/03/02 Renewal|CEP granted|02/03/2026;
Minor revision|Accepted - CEP remains valid|19/07/2024;
New application|CEP granted|19/03/2021
2780 Temozolomide BIOPHORE INDIA PHARMACEUTICALS PRIVATE LIMITED Hyderabad IN 100028906;100063062 CEP 2019-053 - Rev 01 2026/03/02 Valid Chemical 2026/03/02 Renewal|CEP granted|02/03/2026
2330 Leflunomide EMCURE PHARMACEUTICALS LIMITED Pune IN 100011677;100099996 CEP 2018-269 - Rev 03 2026/03/02 Valid Chemical 2026/03/02 Renewal|CEP granted|02/03/2026;
Minor revision|CEP granted|11/09/2024;
Minor revision|CEP granted|08/09/2023
1180 Buprenorphine NORAMCO, LLC. Wilmington US 100048651;100080628 CEP 2007-190 - Rev 06 2026/03/02 Valid Chemical 2026/03/02 Minor revision|CEP granted|02/03/2026;
Notification|CEP granted|20/06/2024;
Minor revision|CEP granted|07/12/2022;
Notification|Accepted - CEP remains valid|17/06/2022;
Notification|CEP granted|25/05/2020
2258 Olanzapine ZHEJIANG SUPOR PHARMACEUTICALS CO., LTD. Shaoxing CN 100022886;100031604 CEP 2019-182 - Rev 02 2026/03/02 Valid Chemical 2026/03/02 Renewal|CEP granted|02/03/2026;
Minor revision|CEP granted|12/09/2022;
Minor revision|Accepted - CEP remains valid|09/03/2022
2790 Clopidogrel besilate, Process II, form-III ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2019-243 - Rev 02 2026/03/02 Valid Chemical 2026/03/02 Renewal|CEP granted|02/03/2026;
Minor revision|Accepted - CEP remains valid|21/08/2024;
Minor revision|Accepted - CEP remains valid|05/09/2022;
Notification|Rejected|05/08/2022;
Notification|CEP granted|11/07/2022
823 Etoposide TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 1999-144 - Rev 09 2026/03/02 Valid Chemical 2026/03/02 Minor revision|CEP granted|02/03/2026;
Minor revision|CEP granted|24/03/2025;
Minor revision|Accepted - CEP remains valid|04/03/2024;
Notification|CEP granted|04/01/2022;
Minor revision|CEP granted|29/06/2020
1473 Soya-bean oil, refined, IV SOCIETE INDUSTRIELLE DES OLEAGINEUX SIO Saint Laurent Blangy FR 100018152;100094230 CEP 2011-115 - Rev 04 2026/03/02 Valid Chemical 2026/03/02 Minor revision|CEP granted|02/03/2026;
Notification|CEP granted|16/01/2025;
Minor revision|Accepted - CEP remains valid|26/08/2024;
Minor revision|CEP granted|27/11/2023;
Minor revision|Accepted - CEP remains valid|15/09/2021
1270 Terconazole NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100089573 CEP 2022-298 - Rev 02 2026/03/02 Valid 13/11/2029 Chemical 2026/03/02 Notification|CEP granted|02/03/2026;
Minor revision|CEP granted|27/05/2025;
New application|CEP granted|13/11/2024
1710 Bisoprolol fumarate EGIS Pharmaceuticals PLC. Budapest X HU 100001091;100001662 CEP 2019-090 - Rev 01 2026/02/26 Valid Chemical 2026/02/26 Renewal|CEP granted|26/02/2026

数据库说明:

当前数据更新日期:2026年04月03日。
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