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
2778 Sitagliptin phosphate monohydrate, Process-II AMOLI ORGANICS PRIVATE LIMITED Mumbai IN 100016500;100025303 CEP 2025-485 - Rev 00 2026/03/30 Valid 30/03/2031 Chemical 2026/03/30 New application|CEP granted|30/03/2026
2849 Hydroxychloroquine sulfate EUROAPI HUNGARY KFT. Budapest IV HU 100039256;100061798 CEP 2024-540 - Rev 00 2026/03/30 Valid 30/03/2031 Chemical 2026/03/30 New application|CEP granted|30/03/2026
1442 Leuprorelin SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2014-278 - Rev 02 2026/03/30 Valid Chemical 2026/03/30 Notification|CEP granted|30/03/2026;
Minor revision|CEP granted|19/12/2024;
Renewal|CEP granted|26/02/2021
1314 Dosulepin hydrochloride SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2003-157 - Rev 07 2026/03/30 Valid Chemical 2026/03/30 Notification|CEP granted|30/03/2026;
Minor revision|CEP granted|25/07/2025;
Minor revision|CEP granted|10/08/2023
2762 Capecitabine SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2016-140 - Rev 01 2026/03/30 Valid Chemical 2026/03/30 Notification|CEP granted|30/03/2026;
Renewal|CEP granted|08/09/2022
1002 Diclofenac sodium YUNG ZIP CHEMICAL IND. CO., LTD. Taichung TW 100023062;100031811 CEP 2018-016 - Rev 04 2026/03/30 Valid Chemical 2026/03/30 Minor revision|CEP granted|30/03/2026;
Renewal|CEP granted|20/12/2024;
Minor revision|CEP granted|16/08/2022;
Minor revision|CEP granted|23/09/2021
2306 Gemcitabine hydrochloride SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2007-021 - Rev 03 2026/03/30 Valid Chemical 2026/03/30 Notification|CEP granted|30/03/2026;
Minor revision|CEP granted|12/06/2024
2373 Meloxicam SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2009-184 - Rev 02 2026/03/30 Valid Chemical 2026/03/30 Notification|CEP granted|30/03/2026;
Minor revision|CEP granted|01/03/2024
1448 Metoprolol succinate SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2004-197 - Rev 06 2026/03/30 Valid Chemical 2026/03/30 Notification|CEP granted|30/03/2026;
Minor revision|CEP granted|19/07/2024;
Minor revision|CEP granted|22/08/2023;
Minor revision|Accepted - CEP remains valid|17/03/2021
678 Sodium valproate SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2004-027 - Rev 05 2026/03/30 Valid Chemical 2026/03/30 Notification|CEP granted|30/03/2026;
Minor revision|CEP granted|16/12/2020
599 Cisplatin SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2004-305 - Rev 04 2026/03/27 Valid Chemical 2026/03/27 Notification|CEP granted|27/03/2026;
Minor revision|CEP granted|14/01/2025
2334 Letrozole SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2009-147 - Rev 02 2026/03/27 Valid Chemical 2026/03/27 Notification|CEP granted|27/03/2026;
Notification|Accepted - CEP remains valid|26/06/2023;
Minor revision|Accepted - CEP remains valid|03/10/2022;
Minor revision|CEP granted|08/03/2022;
Monograph revision|Accepted - CEP remains valid|05/03/2021
2017 Oxaliplatin SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2007-044 - Rev 03 2026/03/27 Valid Chemical 2026/03/27 Notification|CEP granted|27/03/2026;
Minor revision|Rejected|02/07/2024;
Minor revision|Accepted - CEP remains valid|27/10/2022;
Minor revision|Accepted - CEP remains valid|17/05/2022;
Notification|Rejected|22/03/2022
2119 Venlafaxine hydrochloride SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2007-151 - Rev 03 2026/03/27 Valid Chemical 2026/03/27 Notification|CEP granted|27/03/2026;
Notification|Accepted - CEP remains valid|22/08/2024;
Notification|Accepted - CEP remains valid|07/08/2023;
Minor revision|Accepted - CEP remains valid|11/03/2022
1699 Mesalazine SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2003-267 - Rev 07 2026/03/27 Valid Chemical 2026/03/27 Notification|CEP granted|27/03/2026;
Minor revision|CEP granted|20/02/2023
2296 Pantoprazole sodium sesquihydrate SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2009-122 - Rev 03 2026/03/27 Valid Chemical 2026/03/27 Notification|CEP granted|27/03/2026;
Minor revision|Accepted - CEP remains valid|10/02/2023
1681 Tramadol hydrochloride SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2002-232 - Rev 08 2026/03/27 Valid Chemical 2026/03/27 Notification|CEP granted|27/03/2026;
Minor revision|CEP granted|12/06/2024;
Minor revision|Accepted - CEP remains valid|20/10/2022
2888 Rupatadine fumarate TYCHE INDUSTRIES LIMITED Hyderabad IN 100019502;100090730 CEP 2018-213 - Rev 02 2026/03/27 Valid Chemical 2026/03/27 Renewal|CEP granted|27/03/2026;
Major revision|Accepted - CEP remains valid|28/08/2023;
Major revision|CEP granted|26/10/2022
2133 Troxerutin CHENGDU OKAY PHARMACEUTICAL CO. LTD. Qionglai CN 100024058;100033233 CEP 2024-296 - Rev 00 2026/03/27 Valid 27/03/2031 Chemical 2026/03/27 New application|CEP granted|27/03/2026
2541 Quetiapine Fumarate VASUDHA PHARMA CHEM LIMITED Hyderabad IN 100011811;100018603 CEP 2019-035 - Rev 03 2026/03/27 Valid Chemical 2026/03/27 Renewal|CEP granted|27/03/2026;
Minor revision|CEP granted|29/11/2023;
Notification|CEP granted|31/01/2023

数据库说明:

当前数据更新日期:2026年04月02日。
©2006-2026 DrugFuture->Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM