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
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
2733 Escitalopram oxalate, Micronised, milled and non-micronised ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN 100011833;100018698 CEP 2016-178 - Rev 02 2026/01/08 Valid Chemical 2026/01/08 Minor revision|CEP granted|08/01/2026;
Minor revision|CEP granted|23/02/2024;
Renewal|CEP granted|19/01/2023;
Minor revision|CEP granted|23/07/2021;
Notification|Accepted - CEP remains valid|04/09/2020
1075 Budesonide CORAL DRUGS PRIVATE LIMITED New Delhi IN 100019182;100042823 CEP 2016-020 - Rev 01 2026/01/06 Valid Chemical 2026/01/06 Minor revision|CEP granted|06/01/2026;
Renewal|CEP granted|15/11/2022
727 Lidocaine APEX HEALTHCARE LIMITED Ankleshwar IN 100039365;100061975 CEP 2024-291 - Rev 00 2026/01/06 Valid 06/01/2031 Chemical 2026/01/06 New application|CEP granted|06/01/2026
760 Cytarabine MAC CHEM PRODUCTS (INDIA) PRIVATE LIMITED Mumbai IN 100023737;100061579 CEP 2012-251 - Rev 03 2026/01/06 Valid Chemical 2026/01/06 Notification|CEP granted|06/01/2026;
Administrative procedure|CEP granted|30/04/2024;
Minor revision|CEP granted|19/05/2022;
Minor revision|Accepted - CEP remains valid|19/07/2021;
Minor revision|Rejected|19/03/2021
2910 Trifluridine, Crystalline form HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2023-437 - Rev 00 2026/01/06 Valid 06/01/2031 Chemical 2026/01/06 New application|CEP granted|06/01/2026
97 Morphine hydrochloride trihydrate S.A.L.A.R.S. S.p.A. Como IT 100017528;100026302 CEP 2009-339 - Rev 02 2026/01/06 Valid Chemical 2026/01/06 Minor revision|CEP granted|06/01/2026;
Monograph revision|CEP granted|20/06/2024
1362 Prilocaine MOEHS IBERICA S.L. Rubi ES 100029092;100068825 CEP 2024-589 - Rev 00 2026/01/06 Valid 06/01/2031 Chemical 2026/01/06 New application|CEP granted|06/01/2026
1092 Cyclizine Hydrochloride BAJAJ HEALTHCARE LIMITED Thane IN 100021782;100061986 CEP 2024-447 - Rev 00 2026/01/06 Valid 06/01/2031 Chemical 2026/01/06 New application|CEP granted|06/01/2026
1197 Dicycloverine Hydrochloride AMI LIFESCIENCES PRIVATE LIMITED Vadodara IN 100021822;100030527 CEP 2024-517 - Rev 00 2026/01/06 Valid 06/01/2031 Chemical 2026/01/06 New application|CEP granted|06/01/2026

数据库说明:

当前数据更新日期:2026年01月13日。
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