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
662 Daunorubicin Hydrochloride ZHEJIANG HISUN PHARMACEUTICAL CO., LTD. Taizhou City CN 100011825;100018687 CEP 2012-380 - Rev 03 2026/01/30 Valid Chemical 2026/01/30 Monograph revision|CEP granted|30/01/2026;
Minor revision|CEP granted|08/03/2024;
Monograph revision|CEP granted|01/08/2023;
Notification|Accepted - CEP remains valid|12/09/2022
549 Dexamethasone sodium phosphate ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD. Taizhou CN 100022759;100031459 CEP 2025-277 - Rev 00 2026/01/30 Valid 30/01/2031 Chemical 2026/01/30 New application|CEP granted|30/01/2026
1274 Tylosin tartrate for veterinary use ELANCO ANIMAL HEALTH INC. Greenfield US 100012274;100020462 CEP 2001-016 - Rev 06 2026/01/30 Valid Chemical 2026/01/30 Notification|CEP granted|30/01/2026;
Notification|CEP granted|09/12/2025;
Notification|Accepted - CEP remains valid|02/06/2025;
Major revision|CEP granted|07/10/2024
578 Ampicillin sodium, Sterile, Process-II APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2024-454 - Rev 00 2026/01/30 Valid 30/01/2031 Chemical 2026/01/30 New application|CEP granted|30/01/2026
2124 Loratadine, Process II, Micronised QUIMICA SINTETICA S.A. Alcala De Henares ES 100012121;100019020 CEP 2025-493 - Rev 00 2026/01/30 Valid 30/01/2031 Chemical 2026/01/30 New application|CEP granted|30/01/2026
432 Rifamycin sodium EUROAPI ITALY S.R.L. Brindisi IT 100039217;100061735 CEP 2011-233 - Rev 05 2026/01/30 Valid Chemical 2026/01/30 Monograph revision|CEP granted|30/01/2026;
Minor revision|CEP granted|09/07/2025;
Minor revision|Accepted - CEP remains valid|27/03/2025;
Notification|CEP granted|17/12/2021;
Notification|Accepted - CEP remains valid|04/08/2021;
Notification|CEP granted|09/11/2020
417 Oxygen, Salerno site SOL S.P.A. Monza IT 100002061;100001723 CEP 2025-380 - Rev 00 2026/01/30 Valid 30/01/2031 Chemical 2026/01/30 New application|CEP granted|30/01/2026
1081 Carboplatin QILU PHARMACEUTICAL CO., LTD. Jinan CN 100014051;100061315 CEP 2010-285 - Rev 05 2026/01/30 Valid Chemical 2026/01/30 Notification|CEP granted|30/01/2026;
Notification|CEP granted|23/05/2025;
Minor revision|CEP granted|14/02/2024;
Notification|Accepted - CEP remains valid|28/01/2022;
Notification|CEP granted|16/09/2021
2858 Mometasone furoate monohydrate STERLING S.p.A. Solomeo Di Corciano IT 100024377;100033551 CEP 2018-185 - Rev 02 2026/01/30 Valid Chemical 2026/01/30 Notification|CEP granted|30/01/2026;
Renewal|CEP granted|14/10/2024
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

数据库说明:

当前数据更新日期:2026年02月03日。
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