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
2173 Gabapentin, Process V ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN 100011833;100018698 CEP 2024-148 - Rev 01 2025/06/02 Valid 19/07/2029 Chemical 2025/06/02 Minor revision|CEP granted|02/06/2025;
New application|CEP granted|19/07/2024
1558 Propofol SI GROUP, INC. The Woodlands US 100025308;100077018 CEP 2002-229 - Rev 05 2025/05/30 Valid Chemical 2025/05/30 Minor revision|CEP granted|30/05/2025;
Minor revision|CEP granted|26/10/2023;
Notification|CEP granted|22/08/2022
2541 Quetiapine Fumarate MEGA FINE PHARMA PRIVATE LIMITED Mumbai IN 100011550;100021133 CEP 2014-198 - Rev 02 2025/05/30 Valid Chemical 2026/04/01 Notification|Accepted - CEP remains valid|01/04/2026;
Minor revision|CEP granted|30/05/2025;
Minor revision|CEP granted|21/11/2023
1632 Celiprolol hydrochloride MOEHS IBERICA S.L. Rubi ES 100029092;100068825 CEP 2007-220 - Rev 05 2025/05/30 Valid Chemical 2025/05/30 Minor revision|CEP granted|30/05/2025;
Minor revision|CEP granted|08/03/2024;
Minor revision|Accepted - CEP remains valid|24/10/2022;
Monograph revision|CEP granted|24/03/2021
2421 Ziprasidone hydrochloride monohydrate APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2012-131 - Rev 02 2025/05/30 Valid Chemical 2025/05/30 Minor revision|CEP granted|30/05/2025;
Notification|CEP granted|11/01/2024;
Minor revision|Accepted - CEP remains valid|17/11/2021;
Minor revision|Accepted - CEP remains valid|29/04/2021
3132 Mirabegron ZHEJIANG HUAYI PHARMACEUTICAL CO., LTD. Jinhua CN 100012165;100019516 CEP 2024-037 - Rev 00 2025/05/30 Valid 30/05/2030 Chemical 2025/05/30 New application|CEP granted|30/05/2025
2858 Mometasone furoate monohydrate WAVELENGTH ENTERPRISES LTD. Petah Tikva IL 100018877;100092992 CEP 2021-233 - Rev 02 2025/05/30 Valid 10/05/2027 Chemical 2025/10/06 Minor revision|Accepted - CEP remains valid|06/10/2025;
Minor revision|CEP granted|30/05/2025;
Notification|CEP granted|18/01/2023;
Notification|Accepted - CEP remains valid|14/06/2022;
New application|CEP granted|10/05/2022
1699 Mesalazine, Regular density BEC CHEMICALS PRIVATE LIMITED Mumbai IN 100016436;100025221 CEP 2019-299 - Rev 01 2025/05/30 Valid Chemical 2025/07/23 Renewal|Accepted - CEP remains valid|23/07/2025;
Minor revision|CEP granted|30/05/2025;
Minor revision|Accepted - CEP remains valid|31/07/2024;
Minor revision|Accepted - CEP remains valid|18/04/2023
1688 Articaine hydrochloride COHANCE LIFESCIENCES LIMITED Mumbai IN 100011755;100090273 CEP 2015-311 - Rev 02 2025/05/30 Valid Chemical 2025/05/30 Minor revision|CEP granted|30/05/2025;
Notification|CEP granted|16/12/2022;
Renewal|CEP granted|15/12/2021
989 Cefotaxime sodium, Sterile, Process 2 QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN 100033695;100052910 CEP 2020-406 - Rev 01 2025/05/30 Valid 18/11/2027 Chemical 2025/05/30 Minor revision|CEP granted|30/05/2025;
New application|CEP granted|21/11/2022
2235 Methylphenidate hydrochloride, Process II JANSSEN PHARMACEUTICA NV Beerse BE 100000625;100005958 CEP 2024-590 - Rev 00 2025/05/30 Valid 30/05/2030 Chemical 2025/05/30 New application|CEP granted|30/05/2025
2338 Mirtazapine, Process-II APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2025-118 - Rev 00 2025/05/30 Valid 30/05/2030 Chemical 2025/05/30 New application|CEP granted|30/05/2025
1700 Mycophenolate mofetil TAPI CZECH INDUSTRIES S.R.O. Opava CZ 100051642;100090678 CEP 2005-239 - Rev 06 2025/05/28 Valid Chemical 2025/05/28 Notification|CEP granted|28/05/2025;
Minor revision|CEP granted|09/01/2025;
Notification|CEP granted|27/11/2020
1449 Mometasone furoate STERLING S.p.A. Solomeo Di Corciano IT 100024377;100033551 CEP 2006-301 - Rev 05 2025/05/28 Valid Chemical 2025/05/28 Notification|CEP granted|28/05/2025;
Minor revision|CEP granted|24/03/2022;
Minor revision|CEP granted|27/08/2021
20 Dextromethorphan hydrobromide monohydrate HY-GRO CHEMICALS PHARMTEK PRIVATE LIMITED Secunderabad IN 100024077;100041595 CEP 2014-023 - Rev 01 2025/05/28 Valid Chemical 2025/05/28 Monograph revision|CEP granted|28/05/2025;
Monograph revision|Accepted - CEP remains valid|02/05/2024;
Minor revision|Accepted - CEP remains valid|29/06/2023;
Minor revision|Accepted - CEP remains valid|23/06/2021;
Renewal|CEP granted|23/07/2020
2296 Pantoprazole sodium sesquihydrate SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2008-323 - Rev 05 2025/05/28 Valid Chemical 2025/05/28 Minor revision|CEP granted|28/05/2025;
Administrative procedure|CEP granted|11/05/2022;
Notification|CEP granted|03/05/2022;
Minor revision|Accepted - CEP remains valid|17/09/2021;
Minor revision|CEP granted|18/11/2020
2777 Pregabalin TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2017-165 - Rev 02 2025/05/28 Valid Chemical 2025/05/28 Minor revision|CEP granted|28/05/2025;
Notification|CEP granted|14/03/2025;
Renewal|CEP granted|18/07/2023;
Minor revision|CEP granted|29/11/2022;
Minor revision|CEP granted|29/11/2021
2573 Candesartan cilexetil, Process-IV SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2019-297 - Rev 03 2025/05/28 Valid Chemical 2025/05/28 Renewal|CEP granted|28/05/2025;
Notification|Accepted - CEP remains valid|25/01/2023;
Minor revision|CEP granted|28/02/2022;
Minor revision|Accepted - CEP remains valid|12/08/2021;
Minor revision|Accepted - CEP remains valid|29/03/2021;
Minor revision|CEP granted|09/10/2020
1169 Piperacillin monohydrate SHANDONG ANSHUN PHARMACEUTICAL CO., LTD. Dezhou City CN 100039958;100064554 CEP 2019-153 - Rev 03 2025/05/28 Valid Chemical 2025/05/28 Renewal|CEP granted|28/05/2025;
Minor revision|CEP granted|31/07/2024;
Minor revision|Accepted - CEP remains valid|16/09/2021;
Monograph revision|CEP granted|16/04/2021
2600 Olmesartan medoxomil, Process II ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2016-111 - Rev 01 2025/05/28 Valid Chemical 2025/05/28 Major revision|CEP granted|28/05/2025;
Renewal|CEP granted|14/04/2022

数据库说明:

当前数据更新日期:2026年04月03日。
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