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
2574 Entacapone, 1313 MACLEODS PHARMACEUTICALS LIMITED Mumbai IN 100021441;100077265 CEP 2021-051 - Rev 01 2026/01/22 Valid 21/10/2026 Chemical 2026/01/22 Minor revision|CEP granted|22/01/2026;
Notification|Rejected|12/09/2022;
New application|CEP granted|21/10/2021
203 Polymyxin B sulfate XELLIA PHARMACEUTICALS APS Copenhagen S DK 100004144;100002734 CEP 1998-061 - Rev 06 2026/01/22 Valid Chemical 2026/01/22 Minor revision|CEP granted|22/01/2026;
Notification|Accepted - CEP remains valid|28/06/2022;
Minor revision|Accepted - CEP remains valid|20/12/2021
2119 Venlafaxine hydrochloride, Form B ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2009-270 - Rev 08 2026/01/22 Valid Chemical 2026/01/22 Minor revision|CEP granted|22/01/2026;
Minor revision|Accepted - CEP remains valid|27/08/2025;
Minor revision|Accepted - CEP remains valid|06/09/2024;
Notification|CEP granted|27/01/2023;
Notification|Accepted - CEP remains valid|07/10/2021;
Minor revision|Accepted - CEP remains valid|12/02/2021
2933 Deferasirox MEDILUX LABORATORIES PRIVATE LIMITED Pithampur IN 100023732;100032901 CEP 2025-040 - Rev 00 2026/01/22 Valid 22/01/2031 Chemical 2026/01/22 New application|CEP granted|22/01/2026
2131 Tamsulosin hydrochloride ASTELLAS PHARMA INC. Tokyo JP 100004276;100008205 CEP 2007-253 - Rev 06 2026/01/22 Valid Chemical 2026/01/22 Notification|CEP granted|22/01/2026;
Notification|CEP granted|24/10/2024;
Notification|CEP granted|11/05/2022;
Minor revision|CEP granted|07/06/2021
2743 Zoledronic acid monohydrate SCINOPHARM TAIWAN LTD. Shanhua TW 100012108;100019515 CEP 2019-281 - Rev 02 2026/01/22 Valid Chemical 2026/01/22 Renewal|CEP granted|22/01/2026;
Notification|CEP granted|16/10/2024
767 Fludrocortisone acetate, Micronised FARMABIOS S.p.A Gropello Cairoli IT 100011643;100021232 CEP 2019-084 - Rev 02 2026/01/21 Valid Chemical 2026/04/14 Minor revision|Rejected|14/04/2026;
Renewal|CEP granted|21/01/2026;
Monograph revision|CEP granted|01/04/2025
2574 Entacapone, Form-A, micronised, non-micronised NEULAND LABORATORIES LIMITED Hyderabad IN 100011545;100062134 CEP 2011-191 - Rev 05 2026/01/21 Valid Chemical 2026/01/21 Minor revision|CEP granted|21/01/2026;
Notification|CEP granted|24/03/2023;
Minor revision|CEP granted|28/09/2022;
Notification|CEP granted|10/12/2021;
Minor revision|Accepted - CEP remains valid|27/08/2021;
Notification|Accepted - CEP remains valid|14/10/2020
1208 Fenbendazole for veterinary use, Process 2 SHAANXI HANJIANG PHARMACEUTICAL GROUP CO., LTD. Hanzhong CN 100012369;100079669 CEP 2018-250 - Rev 03 2026/01/21 Valid Chemical 2026/01/21 Minor revision|CEP granted|21/01/2026;
Renewal|CEP granted|22/04/2024;
Minor revision|CEP granted|28/11/2022
2896 Thiocolchicoside crystallised from ethanol INDIA GLYCOLS LIMITED Dehradun IN 100038944;100061244 CEP 2020-066 - Rev 02 2026/01/21 Valid 06/04/2027 Chemical 2026/01/21 Minor revision|CEP granted|21/01/2026;
Major revision|CEP granted|05/01/2024;
New application|CEP granted|06/04/2022
1444 Macrogols, Type 3350 and 4000 SASOL GERMANY GMBH Marl DE 100043602;100072176 CEP 2009-392 - Rev 02 2026/01/21 Valid Chemical 2026/01/21 Notification|CEP granted|21/01/2026;
Major revision|CEP granted|06/07/2022
2234 Meropenem trihydrate, Synthetic origin, Sterile, Process II SHENZHEN HAIBIN PHARMACEUTICAL CO., LTD. Shenzhen City CN 100021561;100030252 CEP 2024-097 - Rev 02 2026/01/21 Valid 11/06/2030 Chemical 2026/01/21 Minor revision|CEP granted|21/01/2026;
Administrative procedure|CEP granted|19/08/2025;
New application|CEP granted|11/06/2025
2409 Diacerein RAKSHIT PHARMACEUTICALS LIMITED Anakapalli District IN 100039283;100061839 CEP 2024-436 - Rev 00 2026/01/21 Valid 21/01/2031 Chemical 2026/01/21 New application|CEP granted|21/01/2026
2019 Perindopril tert-butylamine, Crystalline form-α MSN PHARMACHEM PRIVATE LIMITED Sangareddy IN 100014794;100023345 CEP 2025-249 - Rev 00 2026/01/21 Valid 21/01/2031 Chemical 2026/01/21 New application|CEP granted|21/01/2026
45 Methyldopa, Site Yongtai Chiral, Process A ZHEJIANG YONGTAI CHIRAL MEDICINE TECHNOLOGY CO. LTD. Taizhou CN 100041319;100068021 CEP 2025-526 - Rev 00 2026/01/21 Valid 21/01/2031 Chemical 2026/01/21 New application|CEP granted|21/01/2026
2637 Pemetrexed disodium heptahydrate JIANGSU HANSOH PHARMACEUTICAL GROUP CO., LTD. Lianyungang City CN 100034195;100092374 CEP 2022-265 - Rev 01 2026/01/21 Valid 19/06/2028 Chemical 2026/01/21 Minor revision|CEP granted|21/01/2026;
Minor revision|Accepted - CEP remains valid|02/10/2024;
New application|CEP granted|19/06/2023
1575 Tiapride hydrochloride ICROM S.R.L. Concorezzo IT 100022464;100031145 CEP 2023-003 - Rev 01 2026/01/20 Valid 19/01/2029 Chemical 2026/01/20 Minor revision|CEP granted|20/01/2026;
New application|CEP granted|19/01/2024
2896 Thiocolchicoside crystallised from ethanol QUAD LIFESCIENCES PRIVATE LIMITED S.A.S Nagar IN 100050170;100087590 CEP 2023-103 - Rev 00 2026/01/20 Valid 20/01/2031 Chemical 2026/01/20 New application|CEP granted|20/01/2026
2617 Aripiprazole ALKEM LABORATORIES LIMITED Mumbai IN 100005554;100010367 CEP 2024-180 - Rev 00 2026/01/20 Valid 20/01/2031 Chemical 2026/01/20 New application|CEP granted|20/01/2026
198 Oxytetracycline hydrochloride HEBEI SHENGXUE DACHENG PHARMACEUTICAL CO. LTD. Shijiazhuang CN 100016575;100025368 CEP 2021-099 - Rev 02 2026/01/20 Valid 16/06/2027 Chemical 2026/01/20 Minor revision|CEP granted|20/01/2026;
Monograph revision|Accepted - CEP remains valid|23/12/2024;
Minor revision|Accepted - CEP remains valid|07/09/2023;
Administrative procedure|CEP granted|28/06/2022;
New application|CEP granted|20/06/2022

数据库说明:

当前数据更新日期:2026年05月28日。
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