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
2992 Lacosamide JUBILANT BIOSYS LIMITED Mysuru IN 100055198;100098088 CEP 2019-049 - Rev 02 2026/01/13 Valid 21/12/2025 Chemical 2026/01/13 Notification|CEP granted|13/01/2026;
Notification|CEP granted|12/08/2022
1458 Oxfendazole For Veterinary Use, Process II ALIVIRA ANIMAL HEALTH LIMITED Visakhapatnam IN 100033528;100052489 CEP 2021-071 - Rev 03 2026/01/13 Valid Chemical 2026/01/13 Renewal|CEP granted|13/01/2026;
Notification|CEP granted|18/04/2023;
Minor revision|CEP granted|20/10/2021;
New application|CEP granted|31/03/2021
1491 Amlodipine besilate AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100046306;100076393 CEP 2019-310 - Rev 02 2026/01/13 Valid 16/08/2026 Chemical 2026/01/13 Monograph revision|CEP granted|13/01/2026;
Minor revision|CEP granted|15/11/2024
2898 Atazanavir sulfate, Micronised and non-micronised, form A GRANULES INDIA LIMITED Hyderabad IN 100011671;100097387 CEP 2020-279 - Rev 02 2026/01/13 Valid 20/06/2027 Chemical 2026/01/13 Minor revision|CEP granted|13/01/2026;
Notification|CEP granted|10/06/2024;
New application|CEP granted|20/06/2022
1573 Sumatriptan succinate, Process II DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2023-022 - Rev 01 2026/01/12 Valid 30/10/2028 Chemical 2026/01/12 Minor revision|CEP granted|12/01/2026;
New application|CEP granted|30/10/2023
821 Estradiol hemihydrate SCHMITT PHARMA GMBH Kleinmachnow DE 100048120;100079611 CEP 2025-211 - Rev 00 2026/01/12 Valid 12/01/2031 Chemical 2026/01/12 New application|CEP granted|12/01/2026
248 Suxamethonium Chloride SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN 100032307;100099917 CEP 2013-210 - Rev 02 2026/01/12 Valid Chemical 2026/01/12 Notification|CEP granted|12/01/2026;
Minor revision|CEP granted|30/05/2024;
Renewal|CEP granted|15/02/2021
1756 Lamotrigine, Anhydrous Form ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2018-295 - Rev 04 2026/01/12 Valid Chemical 2026/01/12 Renewal|CEP granted|12/01/2026;
Minor revision|CEP granted|30/01/2024;
Minor revision|Accepted - CEP remains valid|24/04/2023;
Minor revision|CEP granted|02/12/2022;
Notification|CEP granted|08/07/2022
2411 Epinastine hydrochloride WUHAN CALMLAND PHARMACEUTICALS CO., LTD. Wuhan CN 100049301;100083738 CEP 2024-295 - Rev 00 2026/01/12 Valid 12/01/2031 Chemical 2026/01/12 New application|CEP granted|12/01/2026
2063 Omega-3-acid ethyl esters 60, Containing mixed tocopherols K.D. PHARMA BEXBACH GMBH Bexbach DE 100016421;100092038 CEP 2009-326 - Rev 02 2026/01/08 Valid Chemical 2026/01/08 Minor revision|CEP granted|08/01/2026
67 Folic acid hydrate DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 1996-045 - Rev 08 2026/01/08 Valid Chemical 2026/01/08 Minor revision|CEP granted|08/01/2026;
Notification|CEP granted|17/07/2025;
Administrative procedure|CEP granted|10/08/2023;
Minor revision|CEP granted|06/07/2023;
Monograph revision|Accepted - CEP remains valid|11/05/2022;
Minor revision|CEP granted|27/04/2021
2063 Omega-3-acid ethyl esters 60, Containing alpha tocopherol K.D. PHARMA BEXBACH GMBH Bexbach DE 100016421;100092038 CEP 2007-042 - Rev 01 2026/01/08 Valid Chemical 2026/01/08 Minor revision|CEP granted|08/01/2026
941 Nortriptyline hydrochloride OLON S.P.A. Rodano IT 100012085;100019537 CEP 2013-070 - Rev 03 2026/01/08 Valid Chemical 2026/01/08 Minor revision|CEP granted|08/01/2026;
Administrative procedure|CEP granted|31/05/2023;
Minor revision|CEP granted|19/05/2023;
Minor revision|Accepted - CEP remains valid|16/05/2022
1045 Sulpiride ICROM S.R.L. Concorezzo IT 100022464;100031145 CEP 2011-074 - Rev 04 2026/01/08 Valid Chemical 2026/01/08 Minor revision|CEP granted|08/01/2026;
Minor revision|CEP granted|13/03/2023;
Notification|CEP granted|27/11/2020;
Minor revision|CEP granted|25/02/2020
678 Sodium valproate ANJAN DRUG PRIVATE LIMITED Alathur IN 100023458;100032594 CEP 2003-180 - Rev 04 2026/01/08 Valid Chemical 2026/01/08 Minor revision|CEP granted|08/01/2026
2825 Tigecycline, Form II TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2018-130 - Rev 03 2026/01/08 Valid Chemical 2026/01/08 Renewal|CEP granted|08/01/2026;
Notification|CEP granted|10/03/2022;
Notification|CEP granted|21/12/2021;
Monograph revision|Accepted - CEP remains valid|17/11/2021
942 Omeprazole ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD. Jinhua City CN 100024897;100034088 CEP 2016-109 - Rev 02 2026/01/08 Valid Chemical 2026/01/08 Notification|CEP granted|08/01/2026;
Administrative procedure|CEP granted|30/09/2022;
Renewal|CEP granted|16/09/2022;
Minor revision|CEP granted|17/03/2022;
Minor revision|CEP granted|29/04/2020
1422 Etodolac, Micronised, non-micronised ZAKŁADY FARMACEUTYCZNE POLPHARMA S.A. Starogard Gdański PL 100000470;100001572 CEP 2013-134 - Rev 04 2026/01/08 Valid Chemical 2026/01/08 Notification|CEP granted|08/01/2026;
Minor revision|CEP granted|02/12/2024;
Minor revision|CEP granted|07/02/2023
576 Allopurinol ANUH PHARMA LTD. Mumbai IN 100021566;100030259 CEP 2023-078 - Rev 01 2026/01/08 Valid 25/09/2029 Chemical 2026/01/08 Minor revision|CEP granted|08/01/2026;
New application|CEP granted|25/09/2024
2617 Aripiprazole, Form B NEULAND LABORATORIES LIMITED Hyderabad IN 100011545;100062134 CEP 2017-289 - Rev 04 2026/01/08 Valid Chemical 2026/01/08 Minor revision|CEP granted|08/01/2026;
Renewal|Accepted - CEP remains valid|21/01/2025;
Minor revision|CEP granted|25/04/2024;
Notification|CEP granted|24/03/2023;
Notification|CEP granted|08/09/2021;
Monograph revision|Accepted - CEP remains valid|19/07/2021

数据库说明:

当前数据更新日期:2026年05月28日。
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