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
330 Gelatin, Limed bone gelatin INDIA GELATINE AND CHEMICALS LIMITED Mumbai IN 100054255;100096353 CEP 2003-261 - Rev 02 2025/08/08 Valid Chemical and TSE 2025/08/08 Major revision|CEP granted|08/08/2025
1280 Zolpidem tartrate SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2005-067 - Rev 03 2025/08/08 Valid Chemical 2025/08/08 Minor revision|CEP granted|08/08/2025;
Monograph revision|Accepted - CEP remains valid|02/07/2020
394 Hydrochlorothiazide ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2009-103 - Rev 06 2025/08/08 Valid Chemical 2025/08/08 Minor revision|CEP granted|08/08/2025;
Minor revision|CEP granted|02/10/2023;
Notification|Accepted - CEP remains valid|09/12/2022;
Minor revision|CEP granted|28/09/2022;
Minor revision|CEP granted|09/04/2020
1614 Estradiol valerate, Micronised fine, non-micronised VALDEPHARM Val de Reuil FR 100011898;100018788 CEP 2010-224 - Rev 06 2025/08/08 Valid Chemical 2025/08/08 Minor revision|CEP granted|08/08/2025;
Minor revision|CEP granted|20/06/2024;
Major revision|CEP granted|12/05/2023;
Minor revision|CEP granted|02/09/2021
1020 Ketamine hydrochloride AREVIPHARMA GMBH Radebeul DE 100011616;100022155 CEP 2015-037 - Rev 02 2025/08/08 Valid Chemical 2025/08/08 Minor revision|CEP granted|08/08/2025;
Minor revision|CEP granted|08/02/2023;
Renewal|CEP granted|24/11/2021;
Minor revision|CEP granted|09/10/2020
1793 Oxycodone hydrochloride SPECGX LLC Webster Groves US 100017269;100031662 CEP 2021-375 - Rev 01 2025/08/08 Valid 14/02/2028 Chemical 2025/08/08 Minor revision|CEP granted|08/08/2025;
New application|CEP granted|14/02/2023
1633 Azelastine hydrochloride ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2019-018 - Rev 03 2025/08/08 Valid Chemical 2025/08/08 Renewal|CEP granted|08/08/2025;
Notification|CEP granted|11/07/2022;
Minor revision|CEP granted|08/03/2022
622 Meclozine dihydrochloride FLEMING LABORATORIES LIMITED Nawabpet Village IN 100015641;100024384 CEP 2017-031 - Rev 01 2025/08/08 Valid Chemical 2025/08/08 Renewal|CEP granted|08/08/2025
2932 Rivaroxaban ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2021-238 - Rev 01 2025/08/08 Valid 12/04/2028 Chemical 2025/08/08 Minor revision|CEP granted|08/08/2025;
New application|CEP granted|12/04/2023
1759 Orphenadrine citrate R.L. FINE CHEM PRIVATE LIMITED Bengaluru IN 100016723;100067511 CEP 2022-094 - Rev 01 2025/08/08 Valid 21/05/2029 Chemical 2025/08/08 Minor revision|CEP granted|08/08/2025;
New application|CEP granted|21/05/2024
996 Clindamycin phosphate TOPFOND PHARMACEUTICAL CO., LTD. Zhumadian CN 100023369;100077278 CEP 2023-082 - Rev 00 2025/08/08 Valid 08/08/2030 Chemical 2025/08/08 New application|CEP granted|08/08/2025
2077 Metacresol MEDILUX LABORATORIES PRIVATE LIMITED Pithampur IN 100023732;100032901 CEP 2023-353 - Rev 01 2025/08/08 Valid 05/03/2030 Chemical 2025/08/08 Minor revision|CEP granted|08/08/2025;
Notification|Rejected|20/06/2025;
New application|CEP granted|05/03/2025
547 Cyanocobalamin NINGXIA KINGVIT PHARMACEUTICAL CO., LTD. YinChuan CN 100034223;100090724 CEP 2014-172 - Rev 01 2025/08/07 Valid Chemical 2025/08/07 Minor revision|CEP granted|07/08/2025;
Renewal|CEP granted|29/03/2022
1346 Metamizole sodium monohydrate SHANDONG XINHUA PHARMACEUTICAL CO., LTD. Zibo CN 100011788;100019607 CEP 2001-356 - Rev 05 2025/08/07 Valid Chemical 2025/08/07 Minor revision|CEP granted|07/08/2025;
Notification|Accepted - CEP remains valid|24/06/2024;
Minor revision|Accepted - CEP remains valid|20/01/2023
333 Heparin sodium, For parenteral preparations OPOCRIN SpA Formigine IT 100008856;100018068 CEP 2002-006 - Rev 10 2025/08/07 Valid Chemical 2025/08/07 Major revision|CEP granted|07/08/2025;
Monograph revision|Accepted - CEP remains valid|09/01/2025;
Major revision|CEP granted|12/01/2022
2631 Rosuvastatin calcium, Site 2 ZHEJIANG JIANGBEI NANHAI PHARMACEUTICAL CO., LTD Linhai City CN 100049395;100084081 CEP 2023-066 - Rev 01 2025/08/07 Valid 28/04/2028 Chemical 2025/08/07 Minor revision|CEP granted|07/08/2025;
New application|CEP granted|28/04/2023
781 Phenoxyethanol A&C AMERICAN CHEMICALS LTD. Montreal CA 100038756;100060854 CEP 2016-213 - Rev 03 2025/08/06 Valid Chemical 2025/08/06 Minor revision|CEP granted|06/08/2025;
Renewal|CEP granted|19/01/2024;
Minor revision|CEP granted|20/01/2022
2338 Mirtazapine NEULAND LABORATORIES LIMITED Hyderabad IN 100011545;100062134 CEP 2008-243 - Rev 06 2025/08/06 Valid Chemical 2025/08/06 Minor revision|CEP granted|06/08/2025;
Notification|CEP granted|19/12/2022;
Minor revision|Accepted - CEP remains valid|20/09/2022;
Minor revision|Accepted - CEP remains valid|09/12/2021;
Major revision|CEP granted|08/09/2020
1705 Sertraline hydrochloride WANBURY LIMITED Vashi, Navi Mumbai IN 100021364;100030068 CEP 2008-173 - Rev 07 2025/08/06 Valid Chemical 2025/08/06 Minor revision|CEP granted|06/08/2025;
Minor revision|CEP granted|08/04/2022;
Minor revision|Accepted - CEP remains valid|18/05/2021;
Minor revision|CEP granted|07/09/2020
2254 Moxifloxacin hydrochloride, Process II DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2013-078 - Rev 02 2025/08/06 Valid Chemical 2025/08/06 Minor revision|CEP granted|06/08/2025;
Major revision|CEP granted|21/08/2024;
Minor revision|Abandoned|20/06/2024;
Minor revision|Accepted - CEP remains valid|07/06/2023;
Monograph revision|Accepted - CEP remains valid|22/01/2021

数据库说明:

当前数据更新日期:2025年12月22日。
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