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
2244 Tacrolimus monohydrate, Process II CONCORD BIOTECH LIMITED Ahmedabad IN 100005519;100000897 CEP 2020-227 - Rev 02 2025/07/29 Valid Chemical 2025/07/29 Renewal|CEP granted|29/07/2025;
Major revision|CEP granted|19/12/2022;
New application|CEP granted|26/11/2020
3139 Brivaracetam, Micronised and Non-micronised MAITHRI LABORATORIES PRIVATE LIMITED Gaddapotharam Village IN 100013041;100021615 CEP 2024-061 - Rev 01 2025/07/29 Valid 12/08/2029 Chemical 2025/07/29 Minor revision|CEP granted|29/07/2025;
New application|CEP granted|12/08/2024
1058 Vancomycin hydrochloride, Lyophilized LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN 100020920;100029633 CEP 2020-058 - Rev 04 2025/07/28 Valid Chemical 2025/07/28 Renewal|CEP granted|28/07/2025;
Monograph revision|CEP granted|28/10/2024;
Minor revision|CEP granted|25/05/2023;
Minor revision|CEP granted|21/01/2022;
New application|CEP granted|22/07/2020
2751 Valaciclovir hydrochloride hydrate FLAMMA S.P.A. Chignolo d'Isola IT 100012051;100020885 CEP 2018-073 - Rev 04 2025/07/28 Valid Chemical 2025/07/28 Transfer of holdership|CEP granted|28/07/2025;
Renewal|CEP granted|21/01/2025;
Minor revision|Accepted - CEP remains valid|24/04/2023;
Minor revision|CEP granted|30/05/2022;
Notification|CEP granted|22/11/2021;
Minor revision|Accepted - CEP remains valid|04/05/2021
714 Doxorubicin Hydrochloride TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2003-111 - Rev 07 2025/07/28 Valid Chemical 2025/12/03 Minor revision|Accepted - CEP remains valid|03/12/2025;
Notification|CEP granted|28/07/2025;
Minor revision|CEP granted|29/05/2024;
Notification|Accepted - CEP remains valid|23/01/2023;
Notification|CEP granted|20/12/2021;
Minor revision|Accepted - CEP remains valid|27/05/2021
1559 Risperidone ICROM S.R.L. Concorezzo IT 100022464;100031145 CEP 2023-293 - Rev 00 2025/07/28 Valid 28/07/2030 Chemical 2025/07/28 New application|CEP granted|28/07/2025
1524 Gliclazide ANUH PHARMA LTD. Mumbai IN 100021566;100030259 CEP 2021-398 - Rev 02 2025/07/28 Valid 11/08/2028 Chemical 2025/07/28 Minor revision|CEP granted|28/07/2025;
Minor revision|CEP granted|20/12/2023;
New application|CEP granted|11/08/2023
1491 Amlodipine besilate, TY 45 DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2025-166 - Rev 00 2025/07/28 Valid 28/07/2030 Chemical 2025/07/28 New application|CEP granted|28/07/2025
1653 Potassium clavulanate, diluted, with microcrystalline Cellulose in the ratio 7:3 FERMIC, S.A. DE C.V. Mexico City MX 100017232;100026028 CEP 2009-358 - Rev 01 2025/07/28 Valid Chemical 2025/07/28 Notification|CEP granted|28/07/2025
574 Cholecalciferol concentrate (powder form), 100 000 IU/g, with all-rac-α-tocopherol DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2019-003 - Rev 01 2025/07/28 Valid Chemical and TSE 2025/07/28 Renewal|CEP granted|28/07/2025;
Minor revision|Accepted - CEP remains valid|30/11/2023
333 Heparin sodium SHENZHEN HEPALINK PHARMACEUTICAL GROUP CO., LTD. Shenzhen City CN 100012154;100018639 CEP 2006-059 - Rev 20 2025/07/28 Valid Chemical 2025/07/28 Major revision|CEP granted|28/07/2025;
Minor revision|CEP granted|27/08/2024;
Monograph revision|CEP granted|14/05/2024;
Administrative procedure|CEP granted|04/10/2023;
Major revision|CEP granted|26/09/2023;
Minor revision|CEP granted|21/02/2023;
Major revision|CEP granted|31/03/2021;
Minor revision|CEP granted|28/10/2020;
Minor revision|CEP granted|21/04/2020
319 Colistimethate sodium LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN 100020920;100029633 CEP 2018-085 - Rev 06 2025/07/28 Valid Chemical 2025/07/28 Minor revision|CEP granted|28/07/2025;
Renewal|CEP granted|15/01/2025;
Monograph revision|Accepted - CEP remains valid|24/03/2023;
Administrative procedure|CEP granted|06/12/2022;
Minor revision|CEP granted|28/11/2022;
Minor revision|CEP granted|11/01/2022;
Administrative procedure|CEP granted|05/05/2020
2992 Lacosamide, Crystalline form-1 MSN PHARMACHEM PRIVATE LIMITED Sangareddy District IN 100014794;100023345 CEP 2018-060 - Rev 05 2025/07/28 Valid Chemical 2025/07/28 Minor revision|CEP granted|28/07/2025;
Renewal|CEP granted|19/07/2024;
Notification|CEP granted|25/10/2023;
Minor revision|CEP granted|14/02/2023;
Minor revision|Accepted - CEP remains valid|02/02/2022;
Minor revision|CEP granted|25/09/2020
2930 Valganciclovir hydrochloride, Crystalline form MAITHRI LABORATORIES PRIVATE LIMITED Gaddapotharam Village IN 100013041;100021615 CEP 2023-285 - Rev 00 2025/07/28 Valid 28/07/2030 Chemical 2025/07/28 New application|CEP granted|28/07/2025
2887 Raltegravir potassium, Form III HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2023-193 - Rev 00 2025/07/28 Valid 28/07/2030 Chemical 2025/07/28 New application|CEP granted|28/07/2025
40 Magnesium oxide, light SCORA Caffiers FR 100017757;100026517 CEP 2024-141 - Rev 00 2025/07/28 Valid 28/07/2030 Chemical 2025/07/28 New application|CEP granted|28/07/2025
. Newborn Bovine Calf Serum GLOBAL LIFE SCIENCES SOLUTIONS NEW ZEALAND Tauranga NZ 100052523;100092494 CEP 2001-190 - Rev 07 2025/07/25 Valid TSE 2025/07/25 Notification|CEP granted|25/07/2025;
Major revision|CEP granted|28/03/2023;
Major revision|CEP granted|22/02/2023;
Notification|Accepted - CEP remains valid|03/03/2022;
Notification|CEP granted|05/06/2020
1339 Levocarnitine NORTHEAST PHARMACEUTICAL GROUP CO. LTD Shenyang CN 100021339;100054155 CEP 2022-068 - Rev 01 2025/07/25 Valid 19/01/2029 Chemical 2025/07/25 Minor revision|CEP granted|25/07/2025;
New application|CEP granted|19/01/2024
1314 Dosulepin hydrochloride SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2003-157 - Rev 06 2025/07/25 Valid Chemical 2025/07/25 Minor revision|CEP granted|25/07/2025;
Minor revision|CEP granted|10/08/2023
2362 Rifaximin, Alpha Form OLON S.P.A. Rodano IT 100012085;100019537 CEP 2019-125 - Rev 04 2025/07/25 Valid Chemical 2025/07/25 Renewal|CEP granted|25/07/2025;
Minor revision|Accepted - CEP remains valid|06/09/2024;
Minor revision|Accepted - CEP remains valid|05/02/2024;
Administrative procedure|CEP granted|05/07/2021;
Minor revision|CEP granted|21/06/2021;
Minor revision|CEP granted|18/12/2020

数据库说明:

当前数据更新日期:2025年12月22日。
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