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
931 Metformin Hydrochloride APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2004-088 - Rev 10 2025/09/18 Valid Chemical 2025/09/18 Minor revision|CEP granted|18/09/2025;
Minor revision|CEP granted|21/11/2024;
Notification|CEP granted|13/12/2023;
Minor revision|CEP granted|02/03/2021
2018 Paroxetine hydrochloride hemihydrate APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2006-206 - Rev 05 2025/09/18 Valid Chemical 2025/09/18 Minor revision|CEP granted|18/09/2025;
Minor revision|Accepted - CEP remains valid|15/10/2024;
Notification|CEP granted|13/12/2023;
Minor revision|CEP granted|26/01/2023;
Minor revision|Accepted - CEP remains valid|13/07/2022;
Notification|Accepted - CEP remains valid|06/11/2020
2617 Aripiprazole ZAKŁADY FARMACEUTYCZNE POLPHARMA S.A. Starogard Gdański PL 100000470;100001572 CEP 2013-230 - Rev 03 2025/09/18 Valid Chemical 2025/09/18 Minor revision|CEP granted|18/09/2025;
Minor revision|CEP granted|17/03/2023;
Monograph revision|CEP granted|16/07/2021;
Renewal|CEP granted|11/06/2020
334 Hydrocortisone acetate, Micronised, Grades I and II SYMBIOTEC PHARMALAB PRIVATE LIMITED Indore IN 100018972;100095999 CEP 2016-228 - Rev 03 2025/09/18 Valid Chemical 2025/09/18 Minor revision|CEP granted|18/09/2025;
Renewal|CEP granted|27/10/2023;
Minor revision|CEP granted|16/09/2022
1287 Alfuzosin hydrochloride APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2007-080 - Rev 04 2025/09/18 Valid Chemical 2025/09/18 Minor revision|CEP granted|18/09/2025;
Minor revision|Accepted - CEP remains valid|29/08/2024;
Notification|CEP granted|16/11/2023;
Notification|Accepted - CEP remains valid|15/07/2021;
Minor revision|Accepted - CEP remains valid|08/09/2020
2409 Diacerein AMI LIFESCIENCES PRIVATE LIMITED Vadodara IN 100021822;100030527 CEP 2015-173 - Rev 04 2025/09/18 Valid Chemical 2025/10/17 Minor revision|Accepted - CEP remains valid|17/10/2025;
Minor revision|CEP granted|18/09/2025;
Minor revision|CEP granted|03/12/2024;
Minor revision|Accepted - CEP remains valid|28/11/2022;
Administrative procedure|CEP granted|04/04/2022;
Notification|CEP granted|18/01/2022;
Renewal|CEP granted|17/11/2021
2751 Valaciclovir hydrochloride hydrate APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2013-318 - Rev 03 2025/09/18 Valid Chemical 2025/09/18 Minor revision|CEP granted|18/09/2025;
Notification|CEP granted|02/02/2024;
Major revision|CEP granted|22/08/2022
2631 Rosuvastatin calcium SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN 100023303;100032437 CEP 2019-309 - Rev 03 2025/09/18 Valid Chemical 2025/09/18 Renewal|CEP granted|18/09/2025;
Minor revision|Accepted - CEP remains valid|14/03/2024;
Notification|CEP granted|26/01/2024;
Minor revision|CEP granted|26/10/2023;
Minor revision|Accepted - CEP remains valid|03/10/2022
2531 Clopidogrel hydrogen sulfate, Form-II MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2018-220 - Rev 05 2025/09/18 Valid Chemical 2025/09/18 Notification|CEP granted|18/09/2025;
Renewal|CEP granted|17/01/2025;
Notification|CEP granted|22/07/2024;
Notification|CEP granted|01/09/2021;
Minor revision|CEP granted|15/07/2021
1658 Spectinomycin sulfate tetrahydrate for veterinary use HEBEI SHENGXUE DACHENG PHARMACEUTICAL CO. LTD. Shijiazhuang City CN 100016575;100025368 CEP 2020-069 - Rev 02 2025/09/18 Valid Chemical 2025/09/18 Renewal|CEP granted|18/09/2025;
Minor revision|CEP granted|06/05/2024;
New application|CEP granted|27/01/2021
2573 Candesartan cilexetil, Process II MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2019-303 - Rev 04 2025/09/18 Valid Chemical 2025/09/18 Notification|CEP granted|18/09/2025;
Renewal|CEP granted|13/05/2025;
Notification|CEP granted|15/07/2024;
Major revision|CEP granted|12/10/2022
884 Carbimazole APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2017-201 - Rev 02 2025/09/18 Valid Chemical 2025/09/18 Minor revision|CEP granted|18/09/2025;
Notification|CEP granted|16/01/2024;
Renewal|CEP granted|13/03/2023;
Minor revision|CEP granted|15/06/2022;
Notification|Accepted - CEP remains valid|12/08/2021;
Minor revision|CEP granted|12/03/2020
2932 Rivaroxaban, Modification-I MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2021-259 - Rev 03 2025/09/18 Valid 27/01/2028 Chemical 2025/09/18 Notification|CEP granted|18/09/2025;
Notification|CEP granted|11/07/2024;
Minor revision|CEP granted|18/12/2023;
New application|CEP granted|27/01/2023
1065 Alprazolam, Process II MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2024-504 - Rev 01 2025/09/18 Valid 28/03/2030 Chemical 2025/09/18 Notification|CEP granted|18/09/2025;
New application|CEP granted|28/03/2025
2573 Candesartan cilexetil, Process 2 ZHUHAI RUNDU PHARMACEUTICAL CO., LTD. Zhuhai City CN 100033558;100052545 CEP 2023-096 - Rev 01 2025/09/18 Valid 19/05/2028 Chemical 2025/12/10 Notification|Accepted - CEP remains valid|10/12/2025;
Major revision|CEP granted|18/09/2025;
New application|CEP granted|19/05/2023
2334 Letrozole TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2022-209 - Rev 02 2025/09/18 Valid 18/03/2029 Chemical 2025/09/18 Minor revision|CEP granted|18/09/2025;
Notification|CEP granted|10/03/2025;
New application|CEP granted|18/03/2024
1065 Alprazolam, Form-III MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2024-586 - Rev 01 2025/09/18 Valid 01/04/2030 Chemical 2025/09/18 Notification|CEP granted|18/09/2025;
New application|CEP granted|01/04/2025
2777 Pregabalin, Process II, Milled, Form-I INTAS PHARMACEUTICALS LIMITED Ahmedabad IN 100011529;100023432 CEP 2022-028 - Rev 02 2025/09/18 Valid 04/07/2028 Chemical 2025/09/18 Minor revision|CEP granted|18/09/2025;
Minor revision|CEP granted|23/09/2024;
New application|CEP granted|04/07/2023
2176 Febantel for veterinary use MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2006-260 - Rev 06 2025/09/17 Valid Chemical 2025/09/17 Notification|CEP granted|17/09/2025;
Notification|CEP granted|22/07/2024;
Notification|CEP granted|01/09/2021
2287 Fluconazole MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2007-256 - Rev 06 2025/09/17 Valid Chemical 2025/09/17 Notification|CEP granted|17/09/2025;
Notification|CEP granted|11/07/2024;
Minor revision|Accepted - CEP remains valid|10/08/2023

数据库说明:

当前数据更新日期:2025年12月20日。
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