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
140 Ethinylestradiol, Dorog site GEDEON RICHTER PLC. Budapest X HU 100000640;100001653 CEP 2025-497 - Rev 00 2026/04/10 Valid 10/04/2031 Chemical 2026/04/10 New application|CEP granted|10/04/2026
140 Ethinylestradiol, Micronised, Dorog site GEDEON RICHTER PLC. Budapest X HU 100000640;100001653 CEP 2025-556 - Rev 00 2026/04/10 Valid 10/04/2031 Chemical 2026/04/10 New application|CEP granted|10/04/2026
2787 Esomeprazole magnesium dihydrate, Micronised, Non-micronised QUIMICA SINTETICA S.A. Alcala De Henares ES 100012121;100019020 CEP 2023-283 - Rev 01 2026/04/10 Valid 18/12/2029 Chemical 2026/04/10 Minor revision|CEP granted|10/04/2026;
New application|CEP granted|18/12/2024
2577 Oxcarbazepine ASSURGEN PHARMA PRIVATE LIMITED Visakhapatnam IN 100048048;100101722 CEP 2023-450 - Rev 01 2026/04/10 Valid 12/11/2030 Chemical 2026/04/10 Notification|CEP granted|10/04/2026;
New application|CEP granted|12/11/2025
678 Sodium valproate, Process 2 ASSURGEN PHARMA PRIVATE LIMITED Visakhapatnam IN 100048048;100101722 CEP 2024-562 - Rev 01 2026/04/10 Valid 28/03/2030 Chemical 2026/04/10 Notification|CEP granted|10/04/2026;
New application|CEP granted|28/03/2025
2992 Lacosamide, Shijiazhuang Site, process B BEIJING HOPE PHARMACEUTICAL CO., LTD. Beijing CN 100050494;100088152 CEP 2025-593 - Rev 00 2026/04/10 Valid 10/04/2031 Chemical 2026/04/10 New application|CEP granted|10/04/2026
1745 Carvedilol, Synthetic route B EGIS PHARMACEUTICALS PLC. Budapest X HU 100001091;100001662 CEP 2016-314 - Rev 01 2026/04/10 Valid Chemical 2026/04/10 Notification|CEP granted|10/04/2026;
Renewal|CEP granted|28/08/2023;
Major revision|CEP granted|02/08/2022;
Minor revision|CEP granted|26/08/2020
768 Hydrocortisone hydrogen succinate SYMBIOTEC PHARMALAB LIMITED Indore IN 100018972;100095999 CEP 2014-120 - Rev 03 2026/04/10 Valid Chemical 2026/04/10 Notification|CEP granted|10/04/2026;
Notification|CEP granted|12/01/2026;
Minor revision|Accepted - CEP remains valid|07/07/2023;
Minor revision|CEP granted|19/08/2021;
Renewal|CEP granted|18/02/2021
1131 Methylprednisolone hydrogen succinate SYMBIOTEC PHARMALAB LIMITED Indore IN 100018972;100095999 CEP 2009-187 - Rev 05 2026/04/10 Valid Chemical 2026/04/10 Notification|CEP granted|10/04/2026;
Notification|Accepted - CEP remains valid|19/01/2026;
Administrative procedure|CEP granted|30/01/2023;
Minor revision|Accepted - CEP remains valid|19/01/2023;
Notification|CEP granted|11/05/2021;
Notification|Accepted - CEP remains valid|12/10/2020
627 Nifedipine IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2014-102 - Rev 02 2026/04/10 Valid Chemical 2026/04/10 Monograph revision|CEP granted|10/04/2026;
Minor revision|CEP granted|20/02/2023;
Minor revision|Accepted - CEP remains valid|08/11/2021;
Renewal|CEP granted|13/01/2021
53 Streptomycin sulfate HEBEI SHENGXUE DACHENG PHARMACEUTICAL CO. LTD. Shijiazhuang CN 100016575;100025368 CEP 2004-052 - Rev 04 2026/04/10 Valid Chemical 2026/04/10 Minor revision|CEP granted|10/04/2026;
Minor revision|Accepted - CEP remains valid|17/05/2023;
Minor revision|Accepted - CEP remains valid|01/12/2021;
Notification|CEP granted|09/09/2021;
Monograph revision|Accepted - CEP remains valid|11/02/2021
38 Levodopa, Micronised I, micronised II and non-micronised ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN 100011833;100018698 CEP 2017-090 - Rev 05 2026/04/10 Valid Chemical 2026/04/10 Major revision|CEP granted|10/04/2026;
Notification|Accepted - CEP remains valid|13/11/2024;
Renewal|CEP granted|24/04/2024;
Minor revision|Accepted - CEP remains valid|28/08/2023;
Minor revision|Accepted - CEP remains valid|28/10/2022;
Minor revision|CEP granted|08/12/2021;
Major revision|CEP granted|30/07/2020
1089 Ciprofloxacin ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shaoxing CN 100022562;100093113 CEP 2020-120 - Rev 04 2026/04/10 Valid Chemical 2026/04/10 Renewal|CEP granted|10/04/2026;
Minor revision|CEP granted|17/01/2025;
Minor revision|CEP granted|03/07/2024;
Minor revision|CEP granted|26/10/2022;
New application|CEP granted|11/06/2021
2775 Nebivolol hydrochloride HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2021-403 - Rev 02 2026/04/10 Valid 06/07/2027 Chemical 2026/04/10 Minor revision|CEP granted|10/04/2026;
Minor revision|Accepted - CEP remains valid|21/10/2025;
Notification|CEP granted|03/12/2024;
Minor revision|Accepted - CEP remains valid|16/02/2023;
New application|CEP granted|06/07/2022
730 Naphazoline Hydrochloride C-SQUARED PHARMA LIMITED Cork IE 100045238;100077698 CEP 2024-411 - Rev 00 2026/04/10 Valid 10/04/2031 Chemical 2026/04/10 New application|CEP granted|10/04/2026
2857 Trazodone hydrochloride BAJAJ HEALTHCARE LIMITED Thane IN 100021782;100061986 CEP 2023-228 - Rev 01 2026/04/10 Valid 09/05/2030 Chemical 2026/04/10 Minor revision|CEP granted|10/04/2026;
New application|CEP granted|09/05/2025
2372 Esomeprazole magnesium trihydrate, Micronised, Non-micronised QUIMICA SINTETICA S.A. Alcala De Henares ES 100012121;100019020 CEP 2023-220 - Rev 01 2026/04/10 Valid 21/10/2029 Chemical 2026/04/10 Minor revision|CEP granted|10/04/2026;
New application|CEP granted|21/10/2024
1756 Lamotrigine IOL CHEMICALS AND PHARMACEUTICALS LIMITED Ludhiana IN 100017919;100037377 CEP 2013-066 - Rev 02 2026/04/09 Valid Chemical 2026/04/09 Minor revision|CEP granted|09/04/2026;
Minor revision|CEP granted|09/01/2023
578 Ampicillin sodium, Sterile FRESENIUS KABI IPSUM S.R.L. Cassina de' Pecchi IT 100015105;100057989 CEP 2012-224 - Rev 07 2026/04/09 Valid Chemical 2026/04/09 Minor revision|CEP granted|09/04/2026;
Major revision|CEP granted|29/08/2025;
Monograph revision|CEP granted|21/02/2024;
Administrative procedure|CEP granted|25/07/2022;
Minor revision|CEP granted|06/05/2022;
Minor revision|CEP granted|04/05/2021;
Notification|CEP granted|11/02/2021
2217 Lamivudine SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO., LTD. Shijiazhuang CN 100047734;100078894 CEP 2019-001 - Rev 01 2026/04/09 Valid Chemical 2026/04/09 Renewal|CEP granted|09/04/2026

数据库说明:

当前数据更新日期:2026年05月27日。
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