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
2258 Olanzapine TORRENT PHARMACEUTICALS LIMITED Ahmedabad IN 100004452;100001862 CEP 2013-177 - Rev 05 2026/03/20 Valid Chemical 2026/03/20 Minor revision|CEP granted|20/03/2026;
Notification|CEP granted|11/01/2024;
Notification|CEP granted|02/11/2023;
Minor revision|CEP granted|06/10/2023;
Minor revision|Accepted - CEP remains valid|01/03/2021
1519 Flurbiprofen, Process II SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2021-039 - Rev 02 2026/03/20 Valid Chemical 2026/03/20 Renewal|CEP granted|20/03/2026;
Monograph revision|CEP granted|10/01/2023;
New application|CEP granted|15/04/2021
883 Calcitriol CARBOGEN AMCIS B.V. Veenendaal NL 100002010;100009870 CEP 1996-009 - Rev 14 2026/03/20 Valid Chemical and TSE 2026/03/20 Minor revision|CEP granted|20/03/2026;
Notification|Rejected|05/02/2026;
Monograph revision|CEP granted|13/12/2024;
Notification|CEP granted|03/03/2020
1794 Paclitaxel, Produced by a semi-synthetic process, product code SPT 1308 SCINOPHARM TAIWAN LTD. Tainan TW 100012108;100019515 CEP 2015-278 - Rev 02 2026/03/20 Valid Chemical 2026/03/20 Minor revision|CEP granted|20/03/2026;
Notification|CEP granted|11/09/2024;
Renewal|CEP granted|10/06/2022;
Minor revision|CEP granted|25/06/2020
2775 Nebivolol hydrochloride, Non-micronised, micronised ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN 100011833;100018698 CEP 2022-140 - Rev 02 2026/03/19 Valid 22/06/2028 Chemical 2026/03/19 Minor revision|CEP granted|19/03/2026;
Minor revision|CEP granted|20/12/2023;
New application|CEP granted|22/06/2023
2366 Galantamine hydrobromide, Isolated from natural sources GALEN-N EOOD Sofia BG 100049230;100083398 CEP 2024-450 - Rev 00 2026/03/19 Valid 19/03/2031 Chemical 2026/03/19 New application|CEP granted|19/03/2026
760 Cytarabine SAKAR HEALTHCARE LIMITED Ahmedabad IN 100033943;100085048 CEP 2025-029 - Rev 00 2026/03/19 Valid 19/03/2031 Chemical 2026/03/19 New application|CEP granted|19/03/2026
565 Sodium nitroprusside MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2024-206 - Rev 00 2026/03/19 Valid 19/03/2031 Chemical 2026/03/19 New application|CEP granted|19/03/2026
2173 Gabapentin, Site Yongtai Chiral ZHEJIANG YONGTAI CHIRAL MEDICINE TECHNOLOGY CO. LTD. Taizhou CN 100041319;100068021 CEP 2022-303 - Rev 01 2026/03/19 Valid 27/10/2027 Chemical 2026/03/19 Minor revision|CEP granted|19/03/2026;
Minor revision|Accepted - CEP remains valid|16/09/2024;
New application|CEP granted|27/10/2022
2591 Celecoxib, Micronised and non-micronised KEKULE PHARMA LIMITED Hyderabad IN 100033239;100051871 CEP 2023-274 - Rev 01 2026/03/19 Valid 03/11/2030 Chemical 2026/03/19 Minor revision|CEP granted|19/03/2026;
New application|CEP granted|03/11/2025
827 Gonadorelin acetate PIRAMAL PHARMA LIMITED Navi Mumbai IN 100036948;100075608 CEP 2025-161 - Rev 00 2026/03/19 Valid 19/03/2031 Chemical 2026/03/19 New application|CEP granted|19/03/2026
353 Prednisolone TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. Tianjin CN 100011805;100018616 CEP 2002-108 - Rev 05 2026/03/19 Valid Chemical 2026/03/19 Minor revision|CEP granted|19/03/2026;
Major revision|Rejected|10/06/2020
740 Sulfadoxine ANUH PHARMA LIMITED Mumbai IN 100021566;100030259 CEP 2022-457 - Rev 01 2026/03/19 Valid 23/02/2029 Chemical 2026/03/19 Minor revision|CEP granted|19/03/2026;
Notification|Accepted - CEP remains valid|06/11/2024;
New application|CEP granted|23/02/2024
2258 Olanzapine, Form-I LEE PHARMA LIMITED Hyderabad IN 100014849;100042625 CEP 2017-020 - Rev 01 2026/03/19 Valid Chemical 2026/03/19 Minor revision|CEP granted|19/03/2026;
Minor revision|Rejected|24/10/2025;
Renewal|CEP granted|22/05/2023;
Major revision|CEP granted|15/03/2023
2223 Glimepiride HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2007-156 - Rev 05 2026/03/19 Valid Chemical 2026/03/19 Minor revision|CEP granted|19/03/2026;
Notification|Accepted - CEP remains valid|25/10/2024;
Notification|Accepted - CEP remains valid|15/12/2023;
Minor revision|Accepted - CEP remains valid|23/11/2021
454 Acetazolamide EMCURE PHARMACEUTICALS LIMITED Pune IN 100011677;100099996 CEP 2018-203 - Rev 03 2026/03/19 Valid Chemical 2026/03/19 Minor revision|CEP granted|19/03/2026;
Renewal|CEP granted|26/02/2025;
Minor revision|CEP granted|27/11/2023;
Minor revision|Accepted - CEP remains valid|13/01/2022
931 Metformin Hydrochloride, 2nd line NINGXIA HENGKANG TECHNOLOGY CO., LTD. Yinchuan CN 100049743;100086705 CEP 2024-237 - Rev 03 2026/03/19 Valid 02/08/2029 Chemical 2026/03/19 Major revision|CEP granted|19/03/2026;
Major revision|CEP granted|14/08/2025;
Minor revision|CEP granted|23/12/2024;
New application|CEP granted|02/08/2024
335 Hydrocortisone HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN 100016183;100024971 CEP 2022-264 - Rev 01 2026/03/19 Valid 22/08/2028 Chemical 2026/03/19 Minor revision|CEP granted|19/03/2026;
New application|CEP granted|22/08/2023
2254 Moxifloxacin hydrochloride HEC PHARM GMBH Berlin DE 100002583;100098718 CEP 2013-225 - Rev 04 2026/03/19 Valid Chemical 2026/03/19 Notification|CEP granted|19/03/2026;
Administrative procedure|CEP granted|03/12/2024;
Minor revision|CEP granted|05/08/2024;
Minor revision|CEP granted|26/08/2021
. Collagen GUANGZHOU TRAUER BIOTECHNOLOGY CO., LTD. Guangzhou CN 100055483;100098662 CEP 2025-482 - Rev 00 2026/03/17 Valid 17/03/2031 TSE 2026/03/19 New application|CEP granted|19/03/2026

数据库说明:

当前数据更新日期:2026年03月22日。
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