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
2270 Sildenafil citrate, Micronised and non-micronised MSN ORGANICS PRIVATE LIMITED Bibinagar Village IN 100012074;100018617 CEP 2013-219 - Rev 02 2026/03/13 Valid Chemical 2026/03/13 Minor revision|CEP granted|13/03/2026;
Minor revision|CEP granted|13/12/2021;
Notification|Accepted - CEP remains valid|25/05/2020
3151 Cannabidiol BSPG LABORATORIES LIMITED Sandwich GB 100033275;100051938 CEP 2024-370 - Rev 00 2026/03/13 Valid 13/03/2031 Chemical 2026/03/13 New application|CEP granted|13/03/2026
1335 Itraconazole, Unit IV (I) NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100089573 CEP 2026-004 - Rev 00 2026/03/13 Valid 13/03/2031 Chemical 2026/03/13 New application|CEP granted|13/03/2026
272 Doxycycline hyclate SHANDONG GUOBANG PHARMACEUTICAL CO., LTD. Weifang CN 100036834;100058198 CEP 2022-336 - Rev 01 2026/03/13 Valid 25/09/2029 Chemical 2026/03/13 Minor revision|CEP granted|13/03/2026;
New application|CEP granted|25/09/2024
1373 Testosterone, Micronised SYMBIOTEC PHARMALAB LIMITED Indore IN 100018972;100095999 CEP 2015-314 - Rev 02 2026/03/12 Valid Chemical 2026/03/12 Notification|CEP granted|12/03/2026;
Notification|Accepted - CEP remains valid|15/11/2023;
Minor revision|CEP granted|30/06/2023;
Renewal|CEP granted|15/06/2022;
Minor revision|Accepted - CEP remains valid|18/10/2021;
Monograph revision|CEP granted|27/07/2020
2331 Rabeprazole sodium hydrate NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100089573 CEP 2018-158 - Rev 02 2026/03/12 Valid Chemical 2026/03/12 Notification|CEP granted|12/03/2026;
Minor revision|Accepted - CEP remains valid|18/06/2025;
Renewal|CEP granted|30/10/2024
2219 Lansoprazole, Unit IV NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100089573 CEP 2020-185 - Rev 02 2026/03/12 Valid Chemical 2026/03/12 Notification|CEP granted|12/03/2026;
Renewal|CEP granted|25/06/2025;
New application|CEP granted|26/08/2020
2541 Quetiapine Fumarate ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO., LTD. Dongyang CN 100022699;100078733 CEP 2025-013 - Rev 00 2026/03/12 Valid 12/03/2031 Chemical 2026/03/12 New application|CEP granted|12/03/2026
2531 Clopidogrel hydrogen sulfate, Form II, Process 3 SYNTHIMED LABS PRIVATE LIMITED Derabassi IN 100052287;100092080 CEP 2026-032 - Rev 00 2026/03/12 Valid 12/03/2031 Chemical 2026/03/12 New application|CEP granted|12/03/2026
1773 Cabergoline LIFECARE LABORATORIES PRIVATE LIMITED Hyderabad IN 100049798;100086853 CEP 2023-093 - Rev 00 2026/03/12 Valid 12/03/2031 Chemical 2026/03/12 New application|CEP granted|12/03/2026
49 Paracetamol IOL CHEMICALS AND PHARMACEUTICALS LIMITED Ludhiana IN 100017919;100037377 CEP 2022-085 - Rev 01 2026/03/12 Valid 03/05/2028 Chemical 2026/03/12 Minor revision|CEP granted|12/03/2026;
Minor revision|Accepted - CEP remains valid|22/08/2025;
Minor revision|Rejected|01/07/2025;
Major revision|Accepted - CEP remains valid|16/11/2023;
New application|CEP granted|03/05/2023
2191 Atorvastatin calcium, TBAH Sulphate Route, Vijayasri Organics APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2024-464 - Rev 00 2026/03/11 Valid 11/03/2031 Chemical 2026/03/11 New application|CEP granted|11/03/2026
3095 Dabigatran etexilate mesilate, Form I, ACL TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2025-606 - Rev 00 2026/03/11 Valid 11/03/2031 Chemical 2026/03/11 New application|CEP granted|11/03/2026
1490 Amisulpride, Process 2 ICROM S.R.L. Concorezzo IT 100022464;100031145 CEP 2019-051 - Rev 05 2026/03/11 Valid Chemical 2026/03/11 Minor revision|CEP granted|11/03/2026;
Renewal|CEP granted|18/09/2024;
Notification|CEP granted|21/11/2023;
Minor revision|CEP granted|30/03/2021;
Notification|CEP granted|27/11/2020;
Notification|Accepted - CEP remains valid|24/08/2020
821 Estradiol hemihydrate, Process B, micronised SHAANXI HANJIANG PHARMACEUTICAL GROUP CO., LTD. Hanzhong CN 100012369;100079669 CEP 2023-179 - Rev 01 2026/03/11 Valid 25/09/2029 Chemical 2026/03/11 Minor revision|CEP granted|11/03/2026;
Major revision|Accepted - CEP remains valid|28/03/2025;
New application|CEP granted|25/09/2024
714 Doxorubicin Hydrochloride INTAS PHARMACEUTICALS LIMITED Ahmedabad IN 100011529;100023432 CEP 2012-367 - Rev 03 2026/03/11 Valid Chemical 2026/03/11 Minor revision|CEP granted|11/03/2026;
Notification|Accepted - CEP remains valid|13/10/2025;
Minor revision|CEP granted|20/03/2024
780 Oxytocin SHENZHEN JYMED TECHNOLOGY CO., LTD. Shenzhen CN 100042374;100070008 CEP 2015-376 - Rev 01 2026/03/11 Valid Chemical 2026/03/11 Minor revision|CEP granted|11/03/2026;
Monograph revision|Accepted - CEP remains valid|12/12/2023;
Renewal|CEP granted|07/11/2022;
Minor revision|CEP granted|28/05/2020
1700 Mycophenolate mofetil EMCURE PHARMACEUTICALS LIMITED Pune IN 100011677;100099996 CEP 2019-089 - Rev 03 2026/03/11 Valid 24/08/2026 Chemical 2026/03/11 Notification|CEP granted|11/03/2026;
Notification|Rejected|31/10/2024;
Minor revision|CEP granted|21/04/2023;
Minor revision|CEP granted|10/02/2022
931 Metformin Hydrochloride, Process-II IOL CHEMICALS AND PHARMACEUTICALS LIMITED Ludhiana IN 100017919;100037377 CEP 2025-564 - Rev 01 2026/03/11 Valid 05/03/2031 Chemical 2026/03/11 Administrative procedure|CEP granted|11/03/2026;
New application|CEP granted|05/03/2026
2932 Rivaroxaban BAJAJ HEALTHCARE LIMITED Thane IN 100021782;100061986 CEP 2023-085 - Rev 01 2026/03/11 Valid 30/04/2030 Chemical 2026/03/11 Minor revision|CEP granted|11/03/2026;
New application|CEP granted|30/04/2025

数据库说明:

当前数据更新日期:2026年04月03日。
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