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
19 Quinine sulfate PT. SINKONA INDONESIA LESTARI Subang ID 100015420;100024139 CEP 2024-412 - Rev 00 2025/04/07 Valid 07/04/2030 Chemical 2025/04/07 New application|CEP granted|07/04/2025
227 Lidocaine hydrochloride monohydrate CHEMINO PHARMA LIMITED Mumbai IN 100049314;100083804 CEP 2021-084 - Rev 01 2025/04/07 Valid 14/08/2029 Chemical 2025/04/07 Minor revision|CEP granted|07/04/2025;
New application|CEP granted|14/08/2024
2857 Trazodone hydrochloride, Milled, Unmilled INTAS PHARMACEUTICALS LIMITED Ahmedabad IN 100011529;100023432 CEP 2024-228 - Rev 00 2025/04/07 Valid 07/04/2030 Chemical 2025/04/07 New application|CEP granted|07/04/2025
2856 Pirfenidone AMOLI ORGANICS PRIVATE LIMITED Mumbai IN 100016500;100025303 CEP 2019-067 - Rev 02 2025/04/07 Valid Chemical 2025/04/07 Renewal|CEP granted|07/04/2025;
Minor revision|CEP granted|11/09/2024;
Minor revision|Accepted - CEP remains valid|22/05/2023;
Notification|Rejected|20/03/2023
1104 Fluoxetine hydrochloride NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100029297 CEP 2023-372 - Rev 00 2025/04/07 Valid 07/04/2030 Chemical 2025/04/07 New application|CEP granted|07/04/2025
2287 Fluconazole, Process II ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2009-226 - Rev 04 2025/04/04 Valid Chemical 2025/04/04 Notification|CEP granted|04/04/2025;
Minor revision|CEP granted|09/01/2025;
Notification|CEP granted|06/12/2022
2631 Rosuvastatin calcium ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2016-175 - Rev 01 2025/04/04 Valid Chemical 2025/04/04 Notification|CEP granted|04/04/2025;
Renewal|CEP granted|26/04/2023;
Notification|CEP granted|06/12/2022;
Major revision|CEP granted|24/06/2022;
Major revision|Rejected|27/08/2021;
Monograph revision|Accepted - CEP remains valid|24/08/2020
2631 Rosuvastatin calcium, D518 Process ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2021-265 - Rev 02 2025/04/04 Valid 05/01/2027 Chemical 2025/04/04 Notification|CEP granted|04/04/2025;
Notification|CEP granted|05/12/2022;
New application|CEP granted|05/01/2022
2585 Rizatriptan benzoate ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2012-108 - Rev 03 2025/04/04 Valid Chemical 2025/04/04 Notification|CEP granted|04/04/2025;
Notification|CEP granted|05/12/2022;
Minor revision|CEP granted|07/01/2022
2856 Pirfenidone ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2017-170 - Rev 04 2025/04/04 Valid Chemical 2025/04/04 Notification|CEP granted|04/04/2025;
Renewal|CEP granted|15/04/2024;
Notification|CEP granted|05/12/2022
2019 Perindopril tert-butylamine ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2004-279 - Rev 06 2025/04/04 Valid Chemical 2025/04/04 Notification|CEP granted|04/04/2025;
Notification|CEP granted|05/12/2022;
Monograph revision|Accepted - CEP remains valid|09/04/2020
228 Lithium carbonate ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2023-190 - Rev 01 2025/04/04 Valid 11/01/2029 Chemical 2025/11/04 Notification|Accepted - CEP remains valid|04/11/2025;
Notification|CEP granted|04/04/2025;
New application|CEP granted|11/01/2024
2992 Lacosamide ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2021-163 - Rev 02 2025/04/04 Valid 14/09/2027 Chemical 2025/04/04 Notification|CEP granted|04/04/2025;
Notification|CEP granted|14/12/2022;
New application|CEP granted|14/09/2022
2223 Glimepiride, Process-II ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2022-481 - Rev 01 2025/04/04 Valid 22/09/2028 Chemical 2025/04/04 Notification|CEP granted|04/04/2025;
New application|CEP granted|22/09/2023
2223 Glimepiride ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2006-172 - Rev 04 2025/04/04 Valid Chemical 2025/04/04 Notification|CEP granted|04/04/2025;
Minor revision|CEP granted|28/11/2022
2736 Imatinib mesilate, β form, milled, non-milled SHANDONG ANXIN PHARMACEUTICAL CO., LTD Jinan CN 100012114;100052387 CEP 2017-292 - Rev 04 2025/04/04 Valid Chemical 2025/04/04 Minor revision|CEP granted|04/04/2025;
Major revision|Accepted - CEP remains valid|26/09/2024;
Renewal|CEP granted|28/06/2024;
Minor revision|CEP granted|27/06/2022
2287 Fluconazole ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2007-100 - Rev 03 2025/04/04 Valid Chemical 2025/04/04 Notification|CEP granted|04/04/2025;
Notification|CEP granted|05/12/2022
1590 Epirubicin hydrochloride SYNBIAS PHARMA AG Schaffhausen CH 100049474;100084538 CEP 2023-380 - Rev 00 2025/04/03 Valid 03/04/2030 Chemical 2025/04/03 New application|CEP granted|03/04/2025
2988 Fingolimod hydrochloride ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2020-108 - Rev 01 2025/04/03 Valid 30/06/2027 Chemical 2025/04/03 Notification|CEP granted|03/04/2025;
Monograph revision|Accepted - CEP remains valid|19/04/2024;
New application|CEP granted|30/06/2022
1058 Vancomycin hydrochloride XELLIA PHARMACEUTICALS APS Copenhagen S DK 100004144;100002734 CEP 2007-195 - Rev 03 2025/04/03 Valid Chemical 2025/04/03 Minor revision|CEP granted|03/04/2025;
Minor revision|Accepted - CEP remains valid|14/03/2024;
Notification|Accepted - CEP remains valid|09/02/2023;
Minor revision|Accepted - CEP remains valid|16/02/2022;
Notification|Accepted - CEP remains valid|15/12/2020

数据库说明:

当前数据更新日期:2026年02月10日。
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