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
474 Chlordiazepoxide hydrochloride, Process 2 F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT 100011866;100022277 CEP 2014-087 - Rev 02 2025/09/12 Valid Chemical 2025/09/12 Minor revision|CEP granted|12/09/2025;
Minor revision|CEP granted|05/04/2023
3087 Ticagrelor JIANGXI SYNERGY PHARMACEUTICAL CO., LTD. Yichun CN 100020812;100080065 CEP 2021-303 - Rev 01 2025/09/12 Valid 08/08/2028 Chemical 2025/09/12 Minor revision|CEP granted|12/09/2025;
New application|CEP granted|08/08/2023
2191 Atorvastatin calcium, Process-IV ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2021-079 - Rev 03 2025/09/12 Valid 05/07/2026 Chemical 2025/09/12 Minor revision|CEP granted|12/09/2025;
Minor revision|CEP granted|29/08/2024;
Monograph revision|CEP granted|01/08/2022;
New application|CEP granted|05/07/2021
2230 Latanoprost C-SQUARED PHARMA LIMITED Cork IE 100045238;100077698 CEP 2024-091 - Rev 00 2025/09/12 Valid 12/09/2030 Chemical 2025/09/12 New application|CEP granted|12/09/2025
1838 Mint oil, partly dementholised, Rectified FREY + LAU GMBH Henstedt-Ulzburg DE 100017333;100026131 CEP 2019-229 - Rev 01 2025/09/11 Valid Herbal 2025/09/11 Renewal|CEP granted|11/09/2025;
Notification|Accepted - CEP remains valid|13/08/2021;
Notification|Accepted - CEP remains valid|11/12/2020
2918 Everolimus, 2.0% BHT FARMHISPANIA S.A. Montmeló ES 100011645;100022190 CEP 2019-256 - Rev 03 2025/09/11 Valid Chemical 2025/09/11 Renewal|CEP granted|11/09/2025;
Major revision|CEP granted|27/04/2023;
Minor revision|CEP granted|24/02/2022
2765 Eplerenone, Form-L HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2019-263 - Rev 03 2025/09/11 Valid 06/04/2026 Chemical 2025/09/11 Minor revision|CEP granted|11/09/2025;
Major revision|CEP granted|05/03/2024;
Minor revision|CEP granted|17/11/2021
2191 Atorvastatin calcium, Form I, ATN process DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2020-092 - Rev 03 2025/09/11 Valid Chemical 2025/09/11 Renewal|CEP granted|11/09/2025;
Minor revision|Accepted - CEP remains valid|13/08/2024;
Minor revision|CEP granted|02/06/2023;
Monograph revision|CEP granted|05/10/2022;
New application|CEP granted|01/10/2020
2617 Aripiprazole, Micronised SYNTHON B.V. Nijmegen NL 100001342;100005475 CEP 2019-191 - Rev 02 2025/09/11 Valid Chemical 2025/09/11 Minor revision|CEP granted|11/09/2025;
Renewal|CEP granted|07/07/2025;
Minor revision|Accepted - CEP remains valid|11/09/2024;
Minor revision|Accepted - CEP remains valid|29/07/2024;
Notification|Rejected|10/06/2024;
Minor revision|Accepted - CEP remains valid|21/11/2023;
Minor revision|Accepted - CEP remains valid|16/06/2022;
Monograph revision|Accepted - CEP remains valid|21/09/2021
2736 Imatinib mesilate, Process II LAURUS LABS LIMITED Hyderabad IN 100011702;100032608 CEP 2020-086 - Rev 02 2025/09/11 Valid Chemical 2025/09/11 Renewal|CEP granted|11/09/2025;
Minor revision|Accepted - CEP remains valid|12/09/2024;
Major revision|CEP granted|03/02/2023;
New application|CEP granted|09/12/2020
1838 Mint oil, partly dementholised, Double rectified FREY + LAU GMBH Henstedt-Ulzburg DE 100017333;100026131 CEP 2019-234 - Rev 01 2025/09/11 Valid Herbal 2025/09/11 Renewal|CEP granted|11/09/2025;
Notification|Accepted - CEP remains valid|13/08/2021;
Notification|Accepted - CEP remains valid|14/12/2020
2931 Sorafenib tosilate, Form-III MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN 100011732;100023530 CEP 2021-430 - Rev 02 2025/09/11 Valid 31/08/2028 Chemical 2025/09/11 Minor revision|CEP granted|11/09/2025;
Monograph revision|Accepted - CEP remains valid|18/06/2025;
Administrative procedure|CEP granted|15/09/2023;
New application|CEP granted|01/09/2023
1286 Alfacalcidol NANJING HERON PHARMACEUTICAL Co., Ltd. Nanjing CN 100050591;100088354 CEP 2024-060 - Rev 01 2025/09/11 Valid 19/12/2029 Chemical and TSE 2025/09/11 Minor revision|CEP granted|11/09/2025;
New application|CEP granted|20/12/2024
2591 Celecoxib ZHEJIANG CHEMSYN PHARM. CO., LTD. Quzhou CN 100025798;100035044 CEP 2020-170 - Rev 01 2025/09/11 Valid Chemical 2025/09/11 Renewal|CEP granted|11/09/2025;
New application|CEP granted|13/01/2021
693 Tretinoin CHONGQING HUAPONT SHENGCHEM PHARMACEUTICAL CO., LTD. Chongqing CN 100024073;100088372 CEP 2020-183 - Rev 01 2025/09/11 Valid 05/09/2027 Chemical 2025/09/11 Minor revision|CEP granted|11/09/2025;
New application|CEP granted|05/09/2022
2970 Almotriptan malate, Crystalline form, micronised and non-micronised MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN 100011732;100018657 CEP 2020-253 - Rev 01 2025/09/11 Valid 25/01/2027 Chemical 2025/09/11 Minor revision|CEP granted|11/09/2025;
Notification|Rejected|11/07/2025;
New application|CEP granted|25/01/2022
2541 Quetiapine Fumarate, Micronised and non-micronised ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN 100011833;100018698 CEP 2022-280 - Rev 02 2025/09/11 Valid 18/03/2029 Chemical 2025/09/11 Minor revision|CEP granted|11/09/2025;
Notification|Accepted - CEP remains valid|24/09/2024;
Administrative procedure|CEP granted|04/04/2024;
New application|CEP granted|18/03/2024
1290 Amikacin sulfate ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD. Jinhua City CN 100024897;100034088 CEP 2023-430 - Rev 01 2025/09/11 Valid 11/07/2030 Chemical 2025/09/11 Minor revision|CEP granted|11/09/2025;
New application|CEP granted|11/07/2025
496 Glycerol KLK EMMERICH GMBH Duesseldorf DE 100048726;100080794 CEP 2024-019 - Rev 00 2025/09/10 Valid 10/09/2030 Chemical 2025/12/17 Minor revision|Accepted - CEP remains valid|17/12/2025;
New application|CEP granted|10/09/2025
2110 Isradipine, Micronised, non-micronised QUIMICA SINTETICA S.A. Alcala De Henares ES 100012121;100019020 CEP 2024-072 - Rev 00 2025/09/10 Valid 10/09/2030 Chemical 2025/09/10 New application|CEP granted|10/09/2025

数据库说明:

当前数据更新日期:2025年12月21日。
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