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
601 Dimenhydrinate CHEMISCHE FABRIK BERG GMBH Bitterfeld-Wolfen DE 100014200;100020038 CEP 2000-235 - Rev 06 2025/10/14 Valid Chemical 2025/10/14 Minor revision|CEP granted|14/10/2025;
Notification|CEP granted|13/01/2022;
Minor revision|Accepted - CEP remains valid|31/05/2021;
Minor revision|Accepted - CEP remains valid|15/12/2020;
Minor revision|Rejected|03/12/2020
803 Amiodarone hydrochloride PMC ISOCHEM Vert Le Petit FR 100011861;100020972 CEP 1997-090 - Rev 12 2025/10/14 Valid Chemical 2025/10/14 Administrative procedure|CEP granted|14/10/2025;
Monograph revision|Accepted - CEP remains valid|19/09/2025;
Minor revision|CEP granted|17/04/2024;
Notification|CEP granted|23/11/2022
309 Acetylsalicylic acid BAYER HISPANIA, S.L. Langreo ES 100000073;100009552 CEP 2001-292 - Rev 05 2025/10/14 Valid Chemical 2025/10/14 Notification|CEP granted|14/10/2025;
Notification|Accepted - CEP remains valid|17/06/2025;
Minor revision|Accepted - CEP remains valid|29/11/2023;
Notification|Accepted - CEP remains valid|22/04/2022
1084 Cetirizine dihydrochloride CIPLA LIMITED Mumbai IN 100006004;100018147 CEP 2000-081 - Rev 08 2025/10/14 Valid Chemical 2025/10/14 Minor revision|CEP granted|14/10/2025;
Notification|Accepted - CEP remains valid|26/04/2022
3095 Dabigatran etexilate mesilate, Micronised KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI 100000627;100009540 CEP 2024-152 - Rev 00 2025/10/14 Valid 14/10/2030 Chemical 2025/10/14 New application|CEP granted|14/10/2025
1280 Zolpidem tartrate, Site-II APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2020-320 - Rev 03 2025/10/14 Valid Chemical 2025/10/14 Renewal|CEP granted|14/10/2025;
Notification|CEP granted|24/01/2024;
Minor revision|CEP granted|22/09/2022;
New application|CEP granted|13/01/2021
331 Gentamicin sulfate FUAN PHARMACEUTICAL GROUP YANTAI JUSTAWARE PHARMACEUTICAL CO., LTD. Yantai CN 100038871;100061089 CEP 2024-008 - Rev 00 2025/10/14 Valid 14/10/2030 Chemical 2025/10/14 New application|CEP granted|14/10/2025
2296 Pantoprazole sodium sesquihydrate, Process III IOL CHEMICALS AND PHARMACEUTICALS LTD Ludhiana IN 100017919;100037377 CEP 2025-303 - Rev 00 2025/10/14 Valid 14/10/2030 Chemical 2025/10/14 New application|CEP granted|14/10/2025
2015 Ebastine, Process-II MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2024-268 - Rev 00 2025/10/14 Valid 14/10/2030 Chemical 2025/10/14 New application|CEP granted|14/10/2025
2675 Irinotecan hydrochloride trihydrate, Process-2 LAURUS LABS LIMITED Hyderabad IN 100011702;100032608 CEP 2025-394 - Rev 00 2025/10/14 Valid 14/10/2030 Chemical 2025/10/14 New application|CEP granted|14/10/2025
576 Allopurinol MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2000-015 - Rev 08 2025/10/10 Valid Chemical 2025/10/10 Notification|CEP granted|10/10/2025;
Notification|CEP granted|25/07/2024
2572 Risedronate sodium 2.5-hydrate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2013-009 - Rev 02 2025/10/10 Valid Chemical 2025/10/10 Notification|CEP granted|10/10/2025;
Notification|CEP granted|30/07/2024;
Monograph revision|Accepted - CEP remains valid|10/07/2023
1451 Mupirocin calcium CONCORD BIOTECH LIMITED Ahmedabad IN 100005519;100000897 CEP 2015-119 - Rev 01 2025/10/10 Valid Chemical 2025/10/10 Minor revision|CEP granted|10/10/2025;
Minor revision|Accepted - CEP remains valid|24/10/2023;
Renewal|CEP granted|16/04/2021
2173 Gabapentin MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2011-185 - Rev 03 2025/10/10 Valid Chemical 2025/10/10 Notification|CEP granted|10/10/2025;
Notification|CEP granted|26/07/2024
2136 Ritonavir, Form-I MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2011-346 - Rev 02 2025/10/10 Valid Chemical 2025/10/10 Notification|CEP granted|10/10/2025;
Notification|CEP granted|26/07/2024;
Minor revision|Accepted - CEP remains valid|24/03/2021
2898 Atazanavir sulfate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2019-203 - Rev 04 2025/10/10 Valid 08/11/2026 Chemical 2025/10/10 Notification|CEP granted|10/10/2025;
Notification|CEP granted|24/07/2024;
Minor revision|CEP granted|17/10/2022;
Major revision|CEP granted|16/09/2022
1611 Diosmin BIORESINE INTERNATIONALE Kenitra MA 100015357;100092292 CEP 2019-205 - Rev 02 2025/10/10 Valid Chemical 2025/10/10 Renewal|CEP granted|10/10/2025;
Minor revision|CEP granted|07/09/2022
1846 Rosemary oil, Rectified; Tunisian type FREY + LAU GMBH Henstedt-Ulzburg DE 100017333;100026131 CEP 2019-276 - Rev 01 2025/10/10 Valid Herbal 2025/10/10 Renewal|CEP granted|10/10/2025;
Notification|Accepted - CEP remains valid|13/08/2021
2931 Sorafenib tosilate GRANULES INDIA LIMITED Hyderabad IN 100011671;100097387 CEP 2022-386 - Rev 01 2025/10/10 Valid 15/11/2029 Chemical 2025/10/10 Monograph revision|CEP granted|10/10/2025;
New application|CEP granted|15/11/2024
766 Flucytosine MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2020-423 - Rev 02 2025/10/10 Valid 03/03/2027 Chemical 2025/10/10 Notification|CEP granted|10/10/2025;
Notification|CEP granted|26/07/2024;
Minor revision|Accepted - CEP remains valid|20/09/2022;
New application|CEP granted|03/03/2022

数据库说明:

当前数据更新日期:2026年04月08日。
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