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
3095 Dabigatran etexilate mesilate, Form-I DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2024-004 - Rev 01 2025/10/30 Valid 25/04/2030 Chemical 2025/10/30 Minor revision|CEP granted|30/10/2025;
New application|CEP granted|25/04/2025
2574 Entacapone FERMION OY Espoo FI 100011508;100020280 CEP 2021-156 - Rev 01 2025/10/30 Valid 29/06/2028 Chemical 2025/10/30 Minor revision|CEP granted|30/10/2025;
New application|CEP granted|30/06/2023
1720 Enilconazole for veterinary use, By crystallization AUDEVARD Clichy FR 100014137;100062693 CEP 2022-261 - Rev 01 2025/10/30 Valid 06/10/2027 Chemical 2025/10/30 Minor revision|CEP granted|30/10/2025;
New application|CEP granted|06/10/2022
749 Vincristine sulfate HUBEI HONCH PHARMACEUTICAL CO., LTD. Huanggang CN 100036821;100058182 CEP 2024-264 - Rev 00 2025/10/30 Valid 30/10/2030 Chemical 2025/10/30 New application|CEP granted|30/10/2025
1796 Sucralfate ZHEJIANG HAISEN PHARMACEUTICAL CO., LTD. Xiangtan Village CN 100024637;100033815 CEP 2019-185 - Rev 02 2025/10/30 Valid Chemical 2025/10/30 Renewal|CEP granted|30/10/2025;
Minor revision|Accepted - CEP remains valid|16/01/2025;
Minor revision|CEP granted|18/08/2023
1448 Metoprolol succinate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2005-221 - Rev 07 2025/10/28 Valid Chemical 2025/10/28 Notification|CEP granted|28/10/2025;
Notification|CEP granted|16/07/2025;
Minor revision|Accepted - CEP remains valid|08/12/2023;
Minor revision|Accepted - CEP remains valid|21/11/2022;
Notification|CEP granted|21/12/2021;
Minor revision|CEP granted|14/10/2020
1488 Alprostadil EVERLIGHT CHEMICAL INDUSTRIAL CORPORATION Taipei TW 100011679;100020963 CEP 2012-204 - Rev 02 2025/10/28 Valid Chemical 2025/10/28 Minor revision|CEP granted|28/10/2025;
Minor revision|CEP granted|27/06/2022
2600 Olmesartan medoxomil VIYASH LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100040217;100065484 CEP 2023-253 - Rev 00 2025/10/28 Valid 28/10/2030 Chemical 2025/10/28 New application|CEP granted|28/10/2025
199 Oxytetracycline dihydrate CIPAN - COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS, S.A. Castanheira do Ribatejo PT 100021412;100078598 CEP 2024-247 - Rev 00 2025/10/28 Valid 28/10/2030 Chemical 2025/10/28 New application|CEP granted|28/10/2025
1665 Betahistine dihydrochloride Grunenthal GmbH Aachen DE 100000515;100006949 CEP 2009-001 - Rev 03 2025/10/28 Valid Chemical 2025/10/28 Minor revision|CEP granted|28/10/2025;
Minor revision|CEP granted|10/04/2025;
Minor revision|Accepted - CEP remains valid|02/10/2024;
Minor revision|Accepted - CEP remains valid|03/01/2023;
Notification|Accepted - CEP remains valid|14/02/2022
369 Azathioprine ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2023-399 - Rev 00 2025/10/28 Valid 28/10/2030 Chemical 2025/10/28 New application|CEP granted|28/10/2025
2119 Venlafaxine hydrochloride ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO., LTD. Dongyang City CN 100022699;100078733 CEP 2023-219 - Rev 00 2025/10/28 Valid 28/10/2030 Chemical 2026/02/27 Minor revision|Accepted - CEP remains valid|27/02/2026;
New application|CEP granted|28/10/2025
2234 Meropenem trihydrate, Sterile, synthetic origin, process II SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2018-268 - Rev 02 2025/10/28 Valid Chemical 2025/10/28 Renewal|CEP granted|28/10/2025;
Minor revision|CEP granted|19/12/2022
2179 Pimobendan for Veterinary Use WISDOM PHARMACEUTICAL CO., LTD. Haimen CN 100014837;100023467 CEP 2013-329 - Rev 01 2025/10/27 Valid Chemical 2025/10/27 Minor revision|CEP granted|27/10/2025;
Minor revision|Accepted - CEP remains valid|29/06/2021;
Renewal|CEP granted|03/05/2021;
Minor revision|Accepted - CEP remains valid|30/10/2020
1961 Poly(vinyl alcohol), Viscosity 5.1 mPa.s, Ester value 140 mg KOH/g MITSUBISHI CHEMICAL CORPORATION Chiyoda JP 100047136;100077835 CEP 2013-209 - Rev 01 2025/10/27 Valid Chemical 2025/10/27 Minor revision|CEP granted|27/10/2025;
Renewal|CEP granted|28/09/2021;
Administrative procedure|CEP granted|13/01/2020
977 Brompheniramine maleate SUPRIYA LIFESCIENCE LIMITED Mumbai IN 100015796;100024574 CEP 2015-097 - Rev 02 2025/10/27 Valid Chemical 2025/10/27 Administrative procedure|CEP granted|27/10/2025;
Major revision|CEP granted|14/05/2025;
Renewal|CEP granted|19/01/2023
2191 Atorvastatin calcium, Form-I LAURUS LABS LIMITED Hyderabad IN 100011702;100032608 CEP 2021-150 - Rev 02 2025/10/27 Valid 18/01/2028 Chemical 2025/10/27 Minor revision|CEP granted|27/10/2025;
Minor revision|Accepted - CEP remains valid|28/06/2024;
Administrative procedure|CEP granted|28/03/2023;
New application|CEP granted|19/01/2023
2631 Rosuvastatin calcium, RS02 CTX LIFESCIENCES PVT. LIMITED Surat IN 100019102;100027863 CEP 2025-419 - Rev 00 2025/10/27 Valid 27/10/2030 Chemical 2025/10/27 New application|CEP granted|27/10/2025
2230 Latanoprost FDC Limited Mumbai IN 100011646;100021030 CEP 2024-162 - Rev 01 2025/10/27 Valid 17/09/2030 Chemical 2025/10/27 Minor revision|CEP granted|27/10/2025;
New application|CEP granted|17/09/2025
2778 Sitagliptin phosphate monohydrate IOL CHEMICALS AND PHARMACEUTICALS LTD Ludhiana IN 100017919;100037377 CEP 2024-063 - Rev 00 2025/10/27 Valid 27/10/2030 Chemical 2025/10/27 New application|CEP granted|27/10/2025

数据库说明:

当前数据更新日期:2026年04月07日。
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