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
1335 Itraconazole, II NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100089573 CEP 2025-246 - Rev 01 2026/05/19 Valid 02/10/2030 Chemical 2026/05/19 Notification|CEP granted|19/05/2026;
New application|CEP granted|02/10/2025
1827 Ginkgo dry extract, refined and quantified, DER:35-67:1 FINZELBERG GMBH & CO. KG Andernach DE 100014516;100022034 CEP 2010-220 - Rev 02 2026/05/19 Valid Herbal 2026/05/19 Minor revision|CEP granted|19/05/2026;
Minor revision|CEP granted|27/11/2024;
Monograph revision|Accepted - CEP remains valid|18/06/2024;
Minor revision|Accepted - CEP remains valid|01/12/2021;
Minor revision|Accepted - CEP remains valid|23/06/2021;
Notification|Rejected|25/05/2021
1181 Buprenorphine hydrochloride, Process II SIEGFRIED AG Zofingen CH 100011797;100022117 CEP 2024-011 - Rev 01 2026/05/19 Valid 10/06/2029 Chemical 2026/05/19 Notification|CEP granted|19/05/2026;
Minor revision|Accepted - CEP remains valid|27/11/2025;
New application|CEP granted|11/06/2024
2585 Rizatriptan benzoate ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100101905 CEP 2012-108 - Rev 04 2026/05/18 Valid Chemical 2026/05/18 Notification|CEP granted|18/05/2026;
Notification|CEP granted|04/04/2025;
Notification|CEP granted|05/12/2022;
Minor revision|CEP granted|07/01/2022
2409 Diacerein ARCHIMICA S.P.A Lodi IT 100012202;100048377 CEP 2014-247 - Rev 01 2026/05/18 Valid Chemical 2026/05/18 Minor revision|CEP granted|18/05/2026;
Renewal|CEP granted|24/06/2021;
Monograph revision|CEP granted|04/11/2020
1058 Vancomycin hydrochloride, Precipitated process ZHEJIANG MEDICINE CO., LTD. Xinchang CN 100022357;100062098 CEP 2010-198 - Rev 05 2026/05/18 Valid Chemical 2026/05/18 Minor revision|CEP granted|18/05/2026;
Minor revision|CEP granted|28/08/2025;
Monograph revision|Accepted - CEP remains valid|31/01/2025;
Minor revision|Accepted - CEP remains valid|17/06/2022
1142 Povidone, iodinated ASHLAND INDUSTRIES EUROPE GMBH Schaffhausen CH 100040941;100067410 CEP 2005-007 - Rev 02 2026/05/18 Valid Chemical 2026/05/18 Minor revision|CEP granted|18/05/2026
1058 Vancomycin hydrochloride, Lyophilised process ZHEJIANG MEDICINE CO., LTD. Xinchang CN 100022357;100062098 CEP 2008-246 - Rev 05 2026/05/18 Valid Chemical 2026/05/18 Minor revision|CEP granted|18/05/2026;
Minor revision|CEP granted|28/08/2025;
Monograph revision|Accepted - CEP remains valid|31/01/2025;
Minor revision|Accepted - CEP remains valid|17/06/2022
931 Metformin Hydrochloride HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2000-059 - Rev 14 2026/05/18 Valid Chemical 2026/05/18 Minor revision|CEP granted|18/05/2026;
Minor revision|CEP granted|11/09/2024;
Minor revision|CEP granted|23/11/2022;
Minor revision|Accepted - CEP remains valid|09/10/2020
1058 Vancomycin hydrochloride, Changhai site (lyophilised process) ZHEJIANG MEDICINE CO., LTD. Shaoxing CN 100022357;100084942 CEP 2023-065 - Rev 02 2026/05/18 Valid 05/04/2028 Chemical 2026/05/18 Minor revision|CEP granted|18/05/2026;
Minor revision|CEP granted|25/08/2025;
Monograph revision|Accepted - CEP remains valid|31/01/2025;
New application|CEP granted|05/04/2023
2988 Fingolimod hydrochloride ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100101905 CEP 2020-108 - Rev 02 2026/05/18 Valid 30/06/2027 Chemical 2026/05/18 Notification|CEP granted|18/05/2026;
Notification|CEP granted|03/04/2025;
Monograph revision|Accepted - CEP remains valid|19/04/2024;
New application|CEP granted|30/06/2022
1680 Pyrantel embonate, Micronised and non-micronised MINSHENG GROUP SHAOXING PHARMACEUTICAL CO., LTD. Shaoxing CN 100023459;100032595 CEP 2020-321 - Rev 02 2026/05/18 Valid 13/05/2027 Chemical 2026/05/18 Minor revision|CEP granted|18/05/2026;
Notification|Accepted - CEP remains valid|02/01/2025;
Minor revision|CEP granted|03/08/2022;
New application|CEP granted|16/05/2022
2856 Pirfenidone ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100101905 CEP 2017-170 - Rev 05 2026/05/18 Valid Chemical 2026/05/18 Notification|CEP granted|18/05/2026;
Notification|CEP granted|04/04/2025;
Renewal|CEP granted|15/04/2024;
Notification|CEP granted|05/12/2022
2373 Meloxicam ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2019-017 - Rev 04 2026/05/18 Valid Chemical 2026/05/18 Renewal|CEP granted|18/05/2026;
Major revision|CEP granted|17/07/2023;
Minor revision|CEP granted|24/11/2022;
Notification|CEP granted|11/07/2022
1535 Levodropropizine MACLEODS PHARMACEUTICALS LIMITED Mumbai IN 100021441;100077265 CEP 2016-174 - Rev 02 2026/05/18 Valid Chemical 2026/05/18 Notification|CEP granted|18/05/2026;
Notification|CEP granted|22/04/2026;
Renewal|CEP granted|21/10/2022;
Major revision|CEP granted|02/08/2022;
Monograph revision|Accepted - CEP remains valid|05/05/2020
2414 Octreotide MATRIX PHARMACORP PRIVATE LIMITED Sangareddy IN 100051463;100098142 CEP 2022-031 - Rev 02 2026/05/18 Valid 07/03/2029 Chemical 2026/05/18 Minor revision|CEP granted|18/05/2026;
Notification|CEP granted|22/07/2024;
New application|CEP granted|07/03/2024
3151 Cannabidiol LINNEA S.A. Locarno CH 100018975;100027746 CEP 2024-462 - Rev 01 2026/05/18 Valid 09/02/2031 Chemical 2026/05/18 Administrative procedure|CEP granted|18/05/2026;
New application|CEP granted|09/02/2026
3095 Dabigatran etexilate mesilate, Form 1, Process II DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2024-365 - Rev 00 2026/05/18 Valid 18/05/2031 Chemical 2026/05/18 New application|CEP granted|18/05/2026
2341 Cefpodoxime proxetil, Process-II PURE AND CURE HEALTHCARE PRIVATE LIMITED Sahibzada Ajit Singh Nagar IN 100045639;100075200 CEP 2025-561 - Rev 00 2026/05/18 Valid 18/05/2031 Chemical 2026/05/18 New application|CEP granted|18/05/2026
1058 Vancomycin hydrochloride, Changhai site (precipitated process) ZHEJIANG MEDICINE CO., LTD. Shaoxing CN 100022357;100084942 CEP 2023-067 - Rev 03 2026/05/18 Valid 05/04/2028 Chemical 2026/05/18 Minor revision|CEP granted|18/05/2026;
Minor revision|CEP granted|25/08/2025;
Monograph revision|CEP granted|03/02/2025;
New application|CEP granted|05/04/2023

数据库说明:

当前数据更新日期:2026年05月22日。
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