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
1275 Ursodeoxycholic acid, UDCA P ICE S.P.A. Reggio Emilia IT 100015143;100023828 CEP 2024-006 - Rev 01 2026/01/30 Valid 21/08/2029 Chemical 2026/01/30 Monograph revision|CEP granted|30/01/2026;
New application|CEP granted|21/08/2024
2631 Rosuvastatin calcium, 1518 MACLEODS PHARMACEUTICALS LIMITED Mumbai IN 100021441;100077265 CEP 2023-356 - Rev 01 2026/01/29 Valid 10/07/2029 Chemical 2026/01/29 Minor revision|CEP granted|29/01/2026;
New application|CEP granted|10/07/2024
2778 Sitagliptin phosphate monohydrate, Process-II BIOCON LIMITED Bengaluru IN 100011487;100018595 CEP 2023-366 - Rev 01 2026/01/29 Valid 20/03/2029 Chemical 2026/01/29 Major revision|CEP granted|29/01/2026;
New application|CEP granted|20/03/2024
2234 Meropenem trihydrate, Sterile, synthetic origin, process I SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou CN 100014777;100050265 CEP 2020-020 - Rev 02 2026/01/29 Valid Chemical 2026/01/29 Renewal|CEP granted|29/01/2026;
Minor revision|Accepted - CEP remains valid|30/05/2025;
Minor revision|Accepted - CEP remains valid|26/05/2023;
Major revision|CEP granted|18/06/2021;
New application|CEP granted|22/03/2021
1444 Macrogols, Types 3350 and 4000 THE DOW CHEMICAL COMPANY Midland US 100011909;100090025 CEP 2006-085 - Rev 06 2026/01/29 Valid Chemical 2026/01/29 Minor revision|CEP granted|29/01/2026;
Notification|CEP granted|25/04/2025;
Administrative procedure|CEP granted|18/09/2024;
Minor revision|Accepted - CEP remains valid|06/06/2024;
Administrative procedure|CEP granted|29/03/2021;
Minor revision|CEP granted|03/02/2021
2779 Solifenacin succinate SAPTAGIR LABORATORIES PRIVATE LMITED Hyderabad IN 100042587;100070387 CEP 2023-384 - Rev 00 2026/01/29 Valid 29/01/2031 Chemical 2026/01/29 New application|CEP granted|29/01/2026
2675 Irinotecan hydrochloride trihydrate, Form-b SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN 100044578;100073706 CEP 2017-147 - Rev 01 2026/01/29 Valid Chemical 2026/01/29 Minor revision|CEP granted|29/01/2026;
Renewal|CEP granted|04/07/2023;
Notification|CEP granted|21/07/2022
432 Rifamycin sodium CKD BIO CORPORATION Ansan-si KR 100018976;100029257 CEP 2010-035 - Rev 03 2026/01/27 Valid Chemical 2026/01/27 Monograph revision|CEP granted|27/01/2026;
Minor revision|CEP granted|25/07/2025;
Notification|Rejected|19/06/2025;
Notification|Accepted - CEP remains valid|25/02/2021
2531 Clopidogrel hydrogen sulfate IOL CHEMICALS AND PHARMACEUTICALS LIMITED Ludhiana IN 100017919;100037377 CEP 2019-006 - Rev 02 2026/01/27 Valid Chemical 2026/01/27 Renewal|CEP granted|27/01/2026;
Minor revision|Accepted - CEP remains valid|05/08/2025;
Minor revision|Accepted - CEP remains valid|04/08/2022;
Administrative procedure|CEP granted|01/06/2021
2600 Olmesartan medoxomil ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2013-297 - Rev 02 2026/01/27 Valid Chemical 2026/01/27 Minor revision|CEP granted|27/01/2026;
Minor revision|Accepted - CEP remains valid|21/01/2025;
Minor revision|Accepted - CEP remains valid|27/08/2024;
Minor revision|CEP granted|12/05/2023;
Minor revision|Accepted - CEP remains valid|21/09/2021;
Renewal|CEP granted|01/07/2021
614 Glycine AMINO GMBH Frellstedt DE 100011599;100021107 CEP 2013-179 - Rev 02 2026/01/27 Valid Chemical 2026/01/27 Minor revision|CEP granted|27/01/2026;
Notification|Accepted - CEP remains valid|13/09/2023;
Minor revision|CEP granted|08/07/2022;
Renewal|CEP granted|31/05/2021
653 Baclofen COHANCE LIFESCIENCES LIMITED Mumbai IN 100011755;100090273 CEP 2018-280 - Rev 03 2026/01/27 Valid 17/06/2026 Chemical 2026/01/27 Monograph revision|CEP granted|27/01/2026;
Minor revision|CEP granted|22/01/2025;
Notification|CEP granted|15/12/2022
2778 Sitagliptin phosphate monohydrate ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN 100012174;100018701 CEP 2020-037 - Rev 02 2026/01/27 Valid 13/07/2026 Chemical 2026/01/27 Minor revision|CEP granted|27/01/2026;
Notification|Accepted - CEP remains valid|06/08/2025;
Minor revision|CEP granted|20/09/2023;
New application|CEP granted|13/07/2021
645 Tobramycin, EHS Optimized Process CHONGQING DAXIN PHARMACEUTICAL CO., LTD. Shuitu Town CN 100011996;100039007 CEP 2019-036 - Rev 02 2026/01/27 Valid Chemical 2026/01/27 Monograph revision|CEP granted|27/01/2026;
Renewal|CEP granted|31/07/2024
1573 Sumatriptan succinate NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100029297 CEP 2024-042 - Rev 00 2026/01/27 Valid 27/01/2031 Chemical 2026/01/27 New application|CEP granted|27/01/2026
922 Ketoprofen ANLON HEALTHCARE LIMITED Gondal IN 100049220;100083386 CEP 2023-344 - Rev 01 2026/01/27 Valid 31/01/2030 Chemical 2026/01/27 Minor revision|CEP granted|27/01/2026;
New application|CEP granted|31/01/2025
1363 Prilocaine Hydrochloride SWATI SPENTOSE PRIVATE LIMITED Mumbai IN 100021605;100052219 CEP 2021-035 - Rev 01 2026/01/27 Valid 14/04/2030 Chemical 2026/01/27 Minor revision|CEP granted|27/01/2026;
New application|CEP granted|14/04/2025
2993 Nilotinib hydrochloride monohydrate, Form-B DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2023-226 - Rev 00 2026/01/26 Valid 26/01/2031 Chemical 2026/01/26 New application|CEP granted|26/01/2026
2423 Valsartan ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2010-065 - Rev 09 2026/01/26 Valid Chemical 2026/01/26 Minor revision|CEP granted|26/01/2026;
Minor revision|CEP granted|27/09/2024;
Minor revision|CEP granted|18/10/2023;
Minor revision|CEP granted|06/10/2020
2631 Rosuvastatin calcium, Amorphous SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2017-069 - Rev 05 2026/01/26 Valid Chemical 2026/01/26 Notification|CEP granted|26/01/2026;
Renewal|CEP granted|28/03/2024;
Minor revision|Accepted - CEP remains valid|31/01/2022;
Minor revision|CEP granted|06/07/2021;
Monograph revision|CEP granted|05/05/2020;
Notification|CEP granted|29/01/2020

数据库说明:

当前数据更新日期:2026年02月10日。
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