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
203 Polymyxin B sulfate North China Pharmaceutical Huasheng Co., Ltd. Shijiazhuang CN 100021261;100029965 CEP 2024-323 - Rev 00 2025/07/11 Valid 11/07/2030 Chemical 2025/07/11 New application|CEP granted|11/07/2025
1182 Calcium ascorbate dihydrate DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2002-253 - Rev 02 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Minor revision|CEP granted|19/03/2024;
Monograph revision|Accepted - CEP remains valid|03/08/2023
1069 Betacarotene DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2010-383 - Rev 02 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025
1559 Risperidone TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2003-110 - Rev 06 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Minor revision|CEP granted|02/05/2023;
Notification|CEP granted|23/02/2022;
Minor revision|CEP granted|03/09/2020
1046 Tamoxifen citrate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 1999-180 - Rev 07 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Notification|CEP granted|21/12/2021;
Notification|CEP granted|07/12/2020
761 Dexpanthenol DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 1997-113 - Rev 04 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Monograph revision|CEP granted|22/04/2021
543 Carbamazepine TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2000-164 - Rev 06 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Notification|CEP granted|21/12/2021
1745 Carvedilol TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2003-048 - Rev 07 2025/07/11 Valid Chemical 2025/12/11 Notification|Accepted - CEP remains valid|11/12/2025;
Notification|CEP granted|11/07/2025;
Notification|CEP granted|23/02/2022;
Notification|CEP granted|19/10/2020
574 Cholecalciferol concentrate (powder form), 100 000 IU/g, with all-rac-α-tocopherol DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2015-199 - Rev 01 2025/07/11 Valid Chemical and TSE 2025/11/27 Notification|Accepted - CEP remains valid|27/11/2025;
Notification|CEP granted|11/07/2025;
Renewal|CEP granted|03/09/2021;
Minor revision|CEP granted|13/08/2020
1559 Risperidone AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100046306;100076393 CEP 2024-147 - Rev 00 2025/07/11 Valid 11/07/2030 Chemical 2025/07/11 New application|CEP granted|11/07/2025
253 Ascorbic acid HEILONGJIANG NHU BIOTECHNOLOGY CO. LTD Suihua City CN 100047549;100078532 CEP 2023-349 - Rev 01 2025/07/10 Valid 19/11/2029 Chemical 2025/07/10 Minor revision|CEP granted|10/07/2025;
New application|CEP granted|19/11/2024
2780 Temozolomide FORMOSA LABORATORIES, INC. Taoyuan TW 100011879;100018688 CEP 2017-245 - Rev 02 2025/07/09 Valid Chemical 2025/07/09 Notification|CEP granted|09/07/2025;
Renewal|CEP granted|26/04/2024;
Notification|Accepted - CEP remains valid|07/07/2022
1004 Diltiazem hydrochloride TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 1997-077 - Rev 16 2025/07/09 Valid Chemical 2025/09/16 Notification|Accepted - CEP remains valid|16/09/2025;
Minor revision|CEP granted|09/07/2025;
Notification|CEP granted|12/03/2025;
Notification|Accepted - CEP remains valid|10/10/2024;
Minor revision|CEP granted|13/12/2021;
Minor revision|CEP granted|25/09/2020
1472 Sodium hyaluronate, Intrinsic viscosity 2.93 m3/kg, by fermentation, for parenteral administration including intra-articular administration and for intra-ocular use KEWPIE CORP. Tokyo JP 100039277;100093553 CEP 2019-064 - Rev 01 2025/07/09 Valid Chemical and TSE 2025/07/09 Renewal|CEP granted|09/07/2025;
Minor revision|Accepted - CEP remains valid|01/12/2020
2330 Leflunomide FORMOSA LABORATORIES, INC. Taoyuan TW 100011879;100018688 CEP 2009-035 - Rev 03 2025/07/09 Valid Chemical 2025/07/09 Notification|CEP granted|09/07/2025;
Minor revision|CEP granted|12/05/2025
734 Prednisolone acetate, Micronised, sterile, alternative process FARMABIOS S.p.A Gropello Cairoli IT 100011643;100021232 CEP 2024-549 - Rev 00 2025/07/09 Valid 09/07/2030 Chemical 2025/07/09 New application|CEP granted|09/07/2025
3132 Mirabegron, α-Form MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN 100011732;100018657 CEP 2024-031 - Rev 00 2025/07/09 Valid 09/07/2030 Chemical 2025/07/09 New application|CEP granted|09/07/2025
2591 Celecoxib AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100046306;100076393 CEP 2019-112 - Rev 01 2025/07/09 Valid Chemical 2026/01/07 Renewal|Accepted - CEP remains valid|07/01/2026;
Minor revision|CEP granted|09/07/2025
2640 Atomoxetine hydrochloride, Process 2 COHANCE LIFESCIENCES LIMITED Mumbai IN 100011755;100090273 CEP 2019-212 - Rev 03 2025/07/09 Valid Chemical 2025/07/09 Renewal|CEP granted|09/07/2025;
Notification|CEP granted|10/07/2024;
Notification|CEP granted|12/02/2021
929 Loperamide hydrochloride TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2008-313 - Rev 04 2025/07/08 Valid Chemical 2025/07/08 Notification|CEP granted|08/07/2025;
Minor revision|Accepted - CEP remains valid|19/06/2024;
Minor revision|Accepted - CEP remains valid|08/08/2022;
Notification|CEP granted|04/01/2022;
Notification|Accepted - CEP remains valid|02/02/2021

数据库说明:

当前数据更新日期:2026年04月06日。
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