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
3139 Brivaracetam MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2024-017 - Rev 00 2025/09/10 Valid 10/09/2030 Chemical 2025/09/10 New application|CEP granted|10/09/2025
921 Ketoconazole AARTI DRUGS LIMITED Mumbai IN 100014953;100023652 CEP 2023-309 - Rev 00 2025/09/10 Valid 10/09/2030 Chemical 2025/09/10 New application|CEP granted|10/09/2025
77 Dapsone NURAY CHEMICALS PRIVATE LIMITED Thiruvallur IN 100048890;100081754 CEP 2023-396 - Rev 00 2025/09/10 Valid 10/09/2030 Chemical 2025/09/10 New application|CEP granted|10/09/2025
3095 Dabigatran etexilate mesilate, Form-I ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2024-081 - Rev 00 2025/09/10 Valid 10/09/2030 Chemical 2025/09/10 New application|CEP granted|10/09/2025
. Bovine pericardium SHANGHAI CINGULAR BIOTECH CORPORATION Shanghai CN 100053718;100095010 CEP 2025-056 - Rev 00 2025/09/10 Valid 10/09/2030 TSE 2025/09/10 New application|CEP granted|10/09/2025
2296 Pantoprazole sodium sesquihydrate SARACA LABORATORIES LIMITED Srikakulam IN 100017715;100082033 CEP 2024-107 - Rev 00 2025/09/10 Valid 10/09/2030 Chemical 2025/09/10 New application|CEP granted|10/09/2025
2201 Carprofen for veterinary use ZENFOLD SUSTAINABLE TECHNOLOGIES PRIVATE LIMITED Bangalore IN 100051186;100089606 CEP 2024-284 - Rev 00 2025/09/10 Valid 10/09/2030 Chemical 2025/09/10 New application|CEP granted|10/09/2025
2778 Sitagliptin phosphate monohydrate AMOLI ORGANICS PRIVATE LIMITED Mumbai IN 100016500;100025303 CEP 2024-161 - Rev 00 2025/09/10 Valid 10/09/2030 Chemical 2025/09/10 New application|CEP granted|10/09/2025
578 Ampicillin sodium, Sterile (Process B) ZHUHAI UNITED LABORATORIES CO., LTD. Sanzao Town CN 100022945;100052547 CEP 2024-414 - Rev 00 2025/09/10 Valid 10/09/2030 Chemical 2025/09/10 New application|CEP granted|10/09/2025
1028 Metoprolol tartrate, Process-II SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2025-238 - Rev 00 2025/09/10 Valid 10/09/2030 Chemical 2025/09/10 New application|CEP granted|10/09/2025
1734 Terbinafine hydrochloride SHANDONG BOYUAN PHARMACEUTICAL CO., LTD. Jinan City CN 100037406;100076812 CEP 2024-205 - Rev 00 2025/09/10 Valid 10/09/2030 Chemical 2025/09/10 New application|CEP granted|10/09/2025
2970 Almotriptan malate SMS PHARMACEUTICALS LIMITED Hyderabad IN 100011780;100061058 CEP 2024-417 - Rev 00 2025/09/10 Valid 10/09/2030 Chemical 2025/09/10 New application|CEP granted|10/09/2025
1558 Propofol NEULAND LABORATORIES LIMITED Hyderabad IN 100011545;100062134 CEP 2013-202 - Rev 04 2025/09/09 Valid Chemical 2025/09/09 Minor revision|CEP granted|09/09/2025;
Minor revision|CEP granted|17/01/2024;
Notification|CEP granted|28/03/2023;
Minor revision|Accepted - CEP remains valid|16/09/2022;
Notification|CEP granted|06/12/2021;
Minor revision|Accepted - CEP remains valid|14/09/2021
2270 Sildenafil citrate RAKSHIT PHARMACEUTICALS LIMITED Anakapalli District IN 100039283;100061839 CEP 2014-361 - Rev 02 2025/09/09 Valid Chemical 2025/09/09 Major revision|CEP granted|09/09/2025;
Notification|CEP granted|11/01/2023;
Renewal|CEP granted|06/09/2021;
Minor revision|Accepted - CEP remains valid|16/11/2020
806 Arginine AMINO GMBH Frellstedt DE 100011599;100021107 CEP 2016-188 - Rev 01 2025/09/09 Valid Chemical 2025/09/09 Minor revision|CEP granted|09/09/2025;
Renewal|CEP granted|19/05/2022
2372 Esomeprazole magnesium trihydrate, Unit IV NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100029297 CEP 2020-343 - Rev 01 2025/09/09 Valid 18/01/2026 Chemical 2025/09/09 Minor revision|CEP granted|09/09/2025;
New application|CEP granted|18/01/2021
253 Ascorbic acid CSPC WEISHENG PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. Shijiazhuang City CN 100024035;100082015 CEP 2004-019 - Rev 07 2025/09/09 Valid Chemical 2025/10/13 Notification|Accepted - CEP remains valid|13/10/2025;
Minor revision|CEP granted|09/09/2025;
Notification|Accepted - CEP remains valid|05/03/2025;
Monograph revision|Accepted - CEP remains valid|18/08/2023;
Notification|Accepted - CEP remains valid|19/04/2023;
Notification|Accepted - CEP remains valid|24/11/2022;
Notification|CEP granted|21/09/2022;
Minor revision|Accepted - CEP remains valid|14/06/2022;
Notification|Rejected|22/04/2022;
Minor revision|Accepted - CEP remains valid|25/01/2022;
Notification|Accepted - CEP remains valid|12/08/2021;
Notification|Accepted - CEP remains valid|01/04/2021;
Minor revision|Accepted - CEP remains valid|13/08/2020;
Minor revision|Abandoned|16/04/2020;
Notification|CEP granted|06/03/2020
2600 Olmesartan medoxomil, Micronised, non-micronised CPL PHARMACEUTICALS PRIVATE LIMITED Ahmedabad IN 100048075;100079517 CEP 2023-089 - Rev 03 2025/09/09 Valid 15/10/2029 Chemical 2025/10/02 Major revision|Rejected|02/10/2025;
Administrative procedure|CEP granted|09/09/2025;
Minor revision|CEP granted|28/08/2025;
Minor revision|CEP granted|05/12/2024;
New application|CEP granted|15/10/2024
96 Mercaptopurine monohydrate AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN 100045727;100075371 CEP 2021-275 - Rev 01 2025/09/09 Valid 09/08/2028 Chemical 2025/12/17 Notification|Accepted - CEP remains valid|17/12/2025;
Minor revision|CEP granted|09/09/2025;
Monograph revision|Accepted - CEP remains valid|22/01/2025;
New application|CEP granted|09/08/2023
2535 Levetiracetam, Form I AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100046306;100076393 CEP 2021-196 - Rev 01 2025/09/09 Valid 13/07/2026 Chemical 2025/09/09 Minor revision|CEP granted|09/09/2025;
New application|CEP granted|13/07/2021

数据库说明:

当前数据更新日期:2025年12月21日。
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