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
929 Loperamide hydrochloride VASUDHA PHARMA CHEM LIMITED Hyderabad IN 100011811;100018603 CEP 2013-333 - Rev 04 2026/02/13 Valid Chemical 2026/02/13 Minor revision|CEP granted|13/02/2026;
Minor revision|CEP granted|11/03/2024;
Notification|CEP granted|30/01/2023;
Minor revision|CEP granted|02/03/2022;
Renewal|CEP granted|06/01/2021
2254 Moxifloxacin hydrochloride, Monohydrate, micronised and non-micronised MSN PHARMACHEM PRIVATE LIMITED Sangareddy IN 100014794;100023345 CEP 2007-355 - Rev 06 2026/02/13 Valid Chemical 2026/02/13 Minor revision|CEP granted|13/02/2026;
Minor revision|CEP granted|02/08/2024;
Administrative procedure|CEP granted|22/09/2021;
Minor revision|Accepted - CEP remains valid|14/09/2021
203 Polymyxin B sulfate, Pyrogen-free HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO., LTD. Hangzhou CN 100016034;100024777 CEP 2024-585 - Rev 00 2026/02/13 Valid 13/02/2031 Chemical and TSE 2026/02/13 New application|CEP granted|13/02/2026
2741 Sulfadimethoxine ANUH PHARMA LIMITED Mumbai IN 100021566;100030259 CEP 2024-522 - Rev 01 2026/02/13 Valid 04/12/2030 Chemical 2026/03/04 Notification|Accepted - CEP remains valid|04/03/2026;
Minor revision|CEP granted|13/02/2026;
New application|CEP granted|04/12/2025
2857 Trazodone hydrochloride ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2022-396 - Rev 01 2026/02/13 Valid 28/02/2029 Chemical 2026/02/13 Minor revision|CEP granted|13/02/2026;
New application|CEP granted|28/02/2024
1674 Mesna SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN 100032307;100099917 CEP 2015-299 - Rev 02 2026/02/13 Valid Chemical 2026/02/13 Minor revision|CEP granted|13/02/2026;
Major revision|CEP granted|20/08/2024;
Renewal|CEP granted|03/02/2022
2787 Esomeprazole magnesium dihydrate HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2014-333 - Rev 04 2026/02/12 Valid Chemical 2026/02/12 Minor revision|CEP granted|12/02/2026;
Notification|CEP granted|06/06/2025;
Minor revision|CEP granted|08/01/2025;
Notification|CEP granted|07/03/2023;
Renewal|CEP granted|26/04/2022;
Minor revision|CEP granted|11/03/2020
890 Clonazepam CENTAUR PHARMACEUTICALS PRIVATE LIMITED Mumbai IN 100018245;100028824 CEP 2006-030 - Rev 04 2026/02/12 Valid Chemical 2026/02/12 Monograph revision|CEP granted|12/02/2026;
Major revision|Accepted - CEP remains valid|30/09/2024;
Notification|CEP granted|20/10/2023;
Major revision|CEP granted|28/04/2023
936 Midazolam WAVELENGTH ENTERPRISES LTD. Petah Tikva IL 100018877;100092992 CEP 2006-267 - Rev 09 2026/02/12 Valid Chemical 2026/02/12 Minor revision|CEP granted|12/02/2026;
Notification|CEP granted|23/10/2024;
Minor revision|CEP granted|05/03/2024;
Minor revision|Accepted - CEP remains valid|02/01/2023;
Minor revision|CEP granted|20/06/2022;
Notification|CEP granted|09/07/2020
2732 Dienogest, Micronised GEDEON RICHTER PLC. Budapest X HU 100000640;100001653 CEP 2020-023 - Rev 01 2026/02/12 Valid 03/05/2027 Chemical 2026/02/12 Major revision|CEP granted|12/02/2026;
New application|CEP granted|03/05/2022
2777 Pregabalin, Route code-PU, form-I, micronised, non-micronised, milled and non-milled MSN PHARMACHEM PRIVATE LIMITED Sangareddy IN 100014794;100023345 CEP 2015-337 - Rev 03 2026/02/12 Valid Chemical 2026/02/12 Minor revision|CEP granted|12/02/2026;
Notification|CEP granted|25/10/2023;
Minor revision|CEP granted|31/08/2022;
Renewal|CEP granted|25/01/2022;
Minor revision|CEP granted|21/04/2021
2616 Topiramate HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2020-130 - Rev 02 2026/02/12 Valid 13/07/2027 Chemical 2026/02/12 Minor revision|CEP granted|12/02/2026;
Notification|CEP granted|06/03/2023;
New application|CEP granted|13/07/2022
1084 Cetirizine dihydrochloride INDOCO REMEDIES LIMITED Mumbai IN 100020134;100061295 CEP 2021-475 - Rev 01 2026/02/12 Valid 11/01/2028 Chemical 2026/02/12 Minor revision|CEP granted|12/02/2026;
New application|CEP granted|11/01/2023
2591 Celecoxib, Site Khazipally AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100046306;100076393 CEP 2023-194 - Rev 02 2026/02/12 Valid 16/08/2028 Chemical 2026/02/12 Minor revision|CEP granted|12/02/2026;
Minor revision|CEP granted|09/12/2025;
New application|CEP granted|16/08/2023
330 Gelatin, Bovine acid hide ROUSSELOT B.V. Son En Breugel NL 100051434;100090148 CEP 2020-357 - Rev 01 2026/02/12 Valid TSE 2026/02/12 Renewal|CEP granted|12/02/2026;
New application|CEP granted|15/04/2021
3137 Dapagliflozin propylene glycol monohydrate, Micronised, non-micronised ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN 100011833;100018698 CEP 2025-128 - Rev 00 2026/02/12 Valid 12/02/2031 Chemical 2026/02/12 New application|CEP granted|12/02/2026
1699 Mesalazine D. K. PHARMA CHEM PRIVATE LIMITED Badlapur IN 100023552;100032697 CEP 2025-039 - Rev 00 2026/02/12 Valid 12/02/2031 Chemical 2026/02/12 New application|CEP granted|12/02/2026
2931 Sorafenib tosilate CIPLA LIMITED Mumbai IN 100006004;100018147 CEP 2024-167 - Rev 00 2026/02/12 Valid 12/02/2031 Chemical 2026/02/12 New application|CEP granted|12/02/2026
1425 Fosfomycin trometamol NANJING DORRA PHARMACEUTICAL TECHNOLOGY CO. LTD. Nanjing CN 100041071;100087393 CEP 2024-168 - Rev 01 2026/02/12 Valid 03/07/2030 Chemical 2026/02/12 Minor revision|CEP granted|12/02/2026;
New application|CEP granted|03/07/2025
1519 Flurbiprofen SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2003-154 - Rev 08 2026/02/11 Valid Chemical 2026/02/11 Administrative procedure|CEP granted|11/02/2026;
Minor revision|CEP granted|02/02/2026;
Monograph revision|CEP granted|14/04/2022;
Minor revision|Rejected|12/10/2020

数据库说明:

当前数据更新日期:2026年04月03日。
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