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
1765 Salmeterol xinafoate, Micronised FARMABIOS S.p.A Gropello Cairoli IT 100011643;100021232 CEP 2018-168 - Rev 01 2025/07/15 Valid Chemical 2025/07/15 Renewal|CEP granted|15/07/2025
576 Allopurinol TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 1998-118 - Rev 08 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Notification|CEP granted|20/12/2021;
Minor revision|Accepted - CEP remains valid|15/03/2021
1028 Metoprolol tartrate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2001-240 - Rev 04 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Minor revision|Accepted - CEP remains valid|22/09/2023;
Notification|CEP granted|04/02/2022
253 Ascorbic acid DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 1996-078 - Rev 06 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Monograph revision|Accepted - CEP remains valid|13/07/2023;
Minor revision|CEP granted|04/10/2022
1651 Clarithromycin TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2004-114 - Rev 05 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Minor revision|Accepted - CEP remains valid|19/03/2024;
Notification|CEP granted|05/01/2022;
Notification|Accepted - CEP remains valid|19/10/2021
807 Ascorbyl palmitate DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2002-255 - Rev 01 2025/07/11 Withdrawn by Holder 2025/09/02 Chemical 2025/07/11
1073 Biotin DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2001-405 - Rev 07 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Minor revision|CEP granted|22/04/2024;
Minor revision|CEP granted|16/01/2023;
Minor revision|CEP granted|02/02/2022
1706 Thiamazole CU Chemie Uetikon GmbH Lahr DE 100012598;100021471 CEP 2008-293 - Rev 02 2025/07/11 Valid Chemical 2025/07/11 Monograph revision|CEP granted|11/07/2025;
Minor revision|CEP granted|04/12/2023
2296 Pantoprazole sodium sesquihydrate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2009-302 - Rev 04 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Minor revision|Accepted - CEP remains valid|10/07/2024;
Notification|CEP granted|21/12/2021;
Minor revision|CEP granted|08/06/2021
2219 Lansoprazole TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2009-301 - Rev 05 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Minor revision|CEP granted|05/04/2024;
Notification|CEP granted|10/03/2022;
Notification|CEP granted|20/12/2021;
Minor revision|Accepted - CEP remains valid|11/12/2020
2404 Drospirenone TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2010-014 - Rev 02 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Minor revision|Accepted - CEP remains valid|20/08/2024;
Minor revision|Accepted - CEP remains valid|16/11/2023;
Minor revision|Accepted - CEP remains valid|13/02/2023;
Notification|CEP granted|04/01/2022
470 Calcium Pantothenate DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2004-267 - Rev 03 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Minor revision|Accepted - CEP remains valid|21/07/2021;
Monograph revision|Accepted - CEP remains valid|16/04/2021
2011 Calcipotriol TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2007-223 - Rev 04 2025/07/11 Valid Chemical 2025/10/31 Notification|Accepted - CEP remains valid|31/10/2025;
Notification|CEP granted|11/07/2025;
Minor revision|Accepted - CEP remains valid|21/02/2023;
Notification|Accepted - CEP remains valid|28/01/2022;
Notification|CEP granted|04/01/2022;
Minor revision|CEP granted|06/01/2021
2191 Atorvastatin calcium, Trihydrate Form-I, ATO3 Process DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2025-113 - Rev 00 2025/07/11 Valid 11/07/2030 Chemical 2025/07/11 New application|CEP granted|11/07/2025
2362 Rifaximin, α-Form APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2024-415 - Rev 00 2025/07/11 Valid 11/07/2030 Chemical 2025/07/11 New application|CEP granted|11/07/2025
549 Dexamethasone sodium phosphate HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN 100016183;100024971 CEP 2023-448 - Rev 00 2025/07/11 Valid 11/07/2030 Chemical 2025/07/11 New application|CEP granted|11/07/2025
2600 Olmesartan medoxomil CHIERON ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN 100053345;100094249 CEP 2018-232 - Rev 02 2025/07/11 Valid Chemical 2025/07/11 Renewal|CEP granted|11/07/2025;
Minor revision|Accepted - CEP remains valid|20/09/2022;
Major revision|CEP granted|08/07/2021;
Minor revision|Rejected|22/02/2021
2071 Milk thistle dry extract, refined and standardised, DER: 20-35:1 NINGBO GREEN-HEALTH PHARMACEUTICAL CO. LTD. Ningbo CN 100021397;100030235 CEP 2012-275 - Rev 02 2025/07/11 Valid Herbal 2025/07/11 Major revision|CEP granted|11/07/2025;
Minor revision|Rejected|07/03/2025;
Minor revision|Accepted - CEP remains valid|18/02/2025;
Monograph revision|CEP granted|19/06/2024
2763 Cisatracurium besilate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2016-093 - Rev 01 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Minor revision|Accepted - CEP remains valid|04/07/2024;
Notification|Accepted - CEP remains valid|13/04/2023;
Renewal|CEP granted|16/05/2022;
Notification|CEP granted|20/12/2021;
Minor revision|CEP granted|29/05/2020
2631 Rosuvastatin calcium, Process G 2410 TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2017-018 - Rev 01 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Renewal|CEP granted|20/05/2022;
Notification|CEP granted|22/11/2021;
Minor revision|CEP granted|09/07/2021;
Monograph revision|Accepted - CEP remains valid|02/10/2020

数据库说明:

当前数据更新日期:2025年12月22日。
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