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
1781 Fludarabine phosphate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2005-257 - Rev 06 2025/07/31 Valid Chemical 2025/07/31 Minor revision|CEP granted|31/07/2025;
Minor revision|CEP granted|09/04/2024;
Notification|Accepted - CEP remains valid|09/09/2022;
Notification|CEP granted|10/11/2021;
Notification|Accepted - CEP remains valid|25/03/2021
2631 Rosuvastatin calcium CHROMO LABORATORIES INDIA PRIVATE LIMITED Pashamylaram IN 100038839;100060978 CEP 2022-009 - Rev 02 2025/07/31 Valid 01/06/2028 Chemical 2025/07/31 Minor revision|CEP granted|31/07/2025;
Minor revision|CEP granted|14/05/2024;
Notification|Rejected|22/03/2024;
New application|CEP granted|01/06/2023
1076 Bumetanide MEDILUX LABORATORIES PRIVATE LIMITED Pithampur IN 100023732;100032901 CEP 2024-248 - Rev 00 2025/07/31 Valid 31/07/2030 Chemical 2025/07/31 New application|CEP granted|31/07/2025
3139 Brivaracetam ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN 100012174;100018701 CEP 2025-089 - Rev 00 2025/07/31 Valid 31/07/2030 Chemical 2025/07/31 New application|CEP granted|31/07/2025
2541 Quetiapine Fumarate, ID 3871 TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2020-234 - Rev 03 2025/07/31 Valid Chemical 2025/07/31 Renewal|CEP granted|31/07/2025;
Minor revision|CEP granted|19/12/2023;
Notification|CEP granted|22/02/2022;
New application|CEP granted|13/11/2020
1524 Gliclazide BAL PHARMA LIMITED Bengaluru IN 100016398;100041736 CEP 2001-273 - Rev 08 2025/07/30 Valid Chemical 2025/07/30 Administrative procedure|CEP granted|30/07/2025;
Notification|CEP granted|19/06/2025;
Notification|CEP granted|21/03/2025;
Notification|CEP granted|23/10/2023;
Minor revision|CEP granted|17/04/2023
2015 Ebastine BAL PHARMA LIMITED Bengaluru IN 100016398;100041736 CEP 2013-051 - Rev 04 2025/07/30 Valid Chemical 2025/07/30 Administrative procedure|CEP granted|30/07/2025;
Notification|CEP granted|19/06/2025;
Notification|CEP granted|22/04/2024;
Minor revision|CEP granted|28/11/2022
1524 Gliclazide, AP BAL PHARMA LIMITED Bengaluru IN 100016398;100041736 CEP 2013-039 - Rev 04 2025/07/30 Valid Chemical 2025/07/30 Administrative procedure|CEP granted|30/07/2025;
Notification|CEP granted|23/06/2025;
Administrative procedure|CEP granted|03/03/2025;
Minor revision|CEP granted|13/02/2025;
Renewal|CEP granted|27/08/2020
267 Caffeine HEBEI GUANGXIANG PHARMACEUTICAL CO. LTD. Cangzhou CN 100048186;100079867 CEP 2024-083 - Rev 01 2025/07/30 Valid 17/06/2030 Chemical 2025/07/30 Administrative procedure|CEP granted|30/07/2025;
New application|CEP granted|17/06/2025
1093 Cyclopentolate hydrochloride ESTEVE QUIMICA S.A. Barcelona ES 100002266;100056508 CEP 2016-078 - Rev 01 2025/07/30 Valid Chemical 2025/07/30 Minor revision|CEP granted|30/07/2025;
Minor revision|Accepted - CEP remains valid|11/01/2024;
Renewal|CEP granted|19/10/2022;
Transfer of holdership|CEP granted|16/03/2022;
Administrative procedure|CEP granted|22/07/2020
845 Mebendazole, Form-C, micronised and non-micronised MSN LIFE SCIENCES PRIVATE LIMITED Medak IN 100018316;100027671 CEP 2018-242 - Rev 02 2025/07/30 Valid Chemical 2025/07/30 Renewal|CEP granted|30/07/2025;
Minor revision|CEP granted|19/08/2022
1425 Fosfomycin trometamol NORTHEAST PHARMACEUTICAL GROUP CO. LTD Shenyang CN 100021339;100054155 CEP 2023-201 - Rev 01 2025/07/30 Valid 20/05/2030 Chemical 2025/07/30 Notification|CEP granted|30/07/2025;
New application|CEP granted|20/05/2025
2631 Rosuvastatin calcium, R1-Process CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. Delft NL 100002351;100005259 CEP 2025-219 - Rev 00 2025/07/30 Valid 30/07/2030 Chemical 2025/07/30 New application|CEP granted|30/07/2025
2270 Sildenafil citrate SMILAX LABORATORIES LIMITED Hyderabad IN 100011578;100021649 CEP 2024-155 - Rev 00 2025/07/30 Valid 30/07/2030 Chemical 2025/07/30 New application|CEP granted|30/07/2025
1280 Zolpidem tartrate LAKE CHEMICALS PRIVATE LIMITED Bengaluru IN 100012055;100053935 CEP 2018-022 - Rev 02 2025/07/29 Valid Chemical 2025/07/29 Minor revision|CEP granted|29/07/2025;
Renewal|CEP granted|03/07/2024;
Monograph revision|Accepted - CEP remains valid|02/10/2020
2021 Terazosin hydrochloride dihydrate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2007-207 - Rev 06 2025/07/29 Valid Chemical 2025/07/29 Notification|CEP granted|29/07/2025;
Minor revision|Accepted - CEP remains valid|01/09/2023;
Monograph revision|CEP granted|19/04/2022;
Notification|Accepted - CEP remains valid|17/09/2020
755 Carbidopa, Micronised FERMION OY Espoo FI 100011508;100020280 CEP 2025-265 - Rev 00 2025/07/29 Valid 29/07/2030 Chemical 2025/07/29 New application|CEP granted|29/07/2025
2196 Bicalutamide, Crystalline form-I, micronised and non-micronised MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN 100011732;100023530 CEP 2012-283 - Rev 02 2025/07/29 Valid Chemical 2025/07/29 Minor revision|CEP granted|29/07/2025;
Notification|CEP granted|10/08/2023
1058 Vancomycin hydrochloride, Precipitated fine powder LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN 100020920;100029633 CEP 2020-119 - Rev 04 2025/07/29 Valid Chemical 2025/07/29 Renewal|CEP granted|29/07/2025;
Monograph revision|CEP granted|29/10/2024;
Notification|Accepted - CEP remains valid|10/06/2024;
Administrative procedure|CEP granted|11/04/2023;
Minor revision|CEP granted|31/03/2023;
Minor revision|Rejected|11/01/2023;
Notification|Accepted - CEP remains valid|27/05/2021;
New application|CEP granted|04/08/2020
2131 Tamsulosin hydrochloride SWATI SPENTOSE PRIVATE LIMITED Mumbai IN 100021605;100052219 CEP 2022-133 - Rev 02 2025/07/29 Valid 30/11/2028 Chemical 2025/07/29 Minor revision|CEP granted|29/07/2025;
Notification|CEP granted|16/09/2024;
New application|CEP granted|30/11/2023

数据库说明:

当前数据更新日期:2026年05月27日。
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