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
798 Fusidic acid, Sterile Powder and Sterile Micronized ERCROS S.A. Aranjuez ES 100016091;100024873 CEP 2023-222 - Rev 00 2023/09/28 Valid 28/09/2028 Chemical 2023/09/28 New application|CEP granted|28/09/2023
2136 Ritonavir SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO., LTD. Laogang Town CN 100032340;100050678 CEP 2017-229 - Rev 02 2023/09/28 Valid 12/07/2024 Chemical 2023/09/28 Minor revision|CEP granted|28/09/2023;
Minor revision|CEP granted|18/03/2020
2593 Docetaxel CHONGQING SINTAHO PHARMACEUTICAL CO., LTD. Maliuzui CN 100041836;100068984 CEP 2022-295 - Rev 00 2023/09/28 Valid 28/09/2028 Chemical 2023/09/28 New application|CEP granted|28/09/2023
1732 Norgestimate Industriale Chimica S.R.L. Saronno IT 100011692;100020331 CEP 2017-189 - Rev 01 2023/09/28 Valid Chemical 2023/09/28 Renewal|CEP granted|28/09/2023;
Minor revision|Accepted - CEP remains valid|01/03/2021;
Notification|Accepted - CEP remains valid|06/08/2020
1240 Mefenamic acid SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN 100032307;100078783 CEP 2007-011 - Rev 07 2023/09/28 Valid Chemical 2023/09/28 Administrative procedure|CEP granted|28/09/2023;
Minor revision|CEP granted|20/09/2023;
Minor revision|CEP granted|31/01/2022
2932 Rivaroxaban Jiangxi Synergy Pharmaceutical Co., Ltd. Fengxin CN 100020812;100083553 CEP 2021-047 - Rev 01 2023/09/28 Valid 26/07/2028 Chemical 2024/02/21 Minor revision|Accepted - CEP remains valid|21/02/2024;
Minor revision|CEP granted|28/09/2023;
New application|CEP granted|26/07/2023
47 Nicotinamide LONZA GUANGZHOU PHARMACEUTICAL LTD Guangzhou CN 100024633;100081573 CEP 2004-110 - Rev 06 2023/09/28 Valid Chemical 2023/09/28 Administrative procedure|CEP granted|28/09/2023;
Notification|Accepted - CEP remains valid|16/08/2023;
Notification|CEP granted|05/05/2021
1611 Diosmin CHENGDU YAZHONG BIO-PHARMACEUTICAL CO., LTD. Pengzhou CN 100048965;100082078 CEP 2017-046 - Rev 01 2023/09/28 Valid Chemical 2023/09/28 Minor revision|CEP granted|28/09/2023;
Renewal|CEP granted|28/11/2022;
Minor revision|Accepted - CEP remains valid|23/06/2020
572 Timolol maleate, Process II PCAS Ecully FR 100011754;100054740 CEP 2014-300 - Rev 01 2023/09/27 Valid Chemical 2023/09/27 Minor revision|CEP granted|27/09/2023;
Notification|Rejected|02/08/2023;
Minor revision|Accepted - CEP remains valid|22/12/2021;
Renewal|CEP granted|15/02/2021
1422 Etodolac, Micronised, non-micronised Zhejiang Chiral Medicine Chemicals Co., Ltd. Hangzhou CN 100022654;100031335 CEP 2009-338 - Rev 02 2023/09/27 Valid Chemical 2023/09/27 Notification|CEP granted|27/09/2023;
Minor revision|Accepted - CEP remains valid|24/08/2023;
Minor revision|Accepted - CEP remains valid|16/09/2022;
Minor revision|Accepted - CEP remains valid|12/08/2021
1722 Flunarizine dihydrochloride FLEMING LABORATORIES LIMITED Nawabpet Village IN 100015641;100024384 CEP 2016-231 - Rev 01 2023/09/27 Valid Chemical 2024/06/07 Renewal|Accepted - CEP remains valid|07/06/2024;
Major revision|CEP granted|27/09/2023
114 Benzylpenicillin sodium, Sterile SANDOZ GMBH Kundl AT 100000546;100000450 CEP 1992-017 - Rev 08 2023/09/27 Valid Chemical 2023/09/27 Minor revision|CEP granted|27/09/2023;
Notification|Accepted - CEP remains valid|27/02/2023;
Minor revision|Accepted - CEP remains valid|05/07/2022;
Notification|Accepted - CEP remains valid|15/12/2020;
Minor revision|Accepted - CEP remains valid|30/04/2020
2591 Celecoxib MACLEODS PHARMACEUTICALS LIMITED Mumbai IN 100021441;100077265 CEP 2015-195 - Rev 01 2023/09/27 Valid Chemical 2024/01/25 Major revision|Accepted - CEP remains valid|25/01/2024;
Major revision|CEP granted|27/09/2023;
Renewal|CEP granted|10/05/2022;
Minor revision|CEP granted|17/12/2021;
Notification|Rejected|05/11/2021
194 Sodium dihydrogen phosphate dihydrate QUALITY CHEMICALS S.L. Esparreguera ES 100025665;100034895 CEP 2017-177 - Rev 02 2023/09/26 Valid Chemical 2023/09/26 Renewal|CEP granted|26/09/2023;
Minor revision|CEP granted|15/09/2021
401 Levothyroxine sodium, Code 460 187 - Code 460 132 SANDOZ GMBH Kundl AT 100000546;100000450 CEP 1998-141 - Rev 11 2023/09/26 Valid Chemical 2023/09/26 Notification|CEP granted|26/09/2023;
Major revision|CEP granted|02/06/2022
394 Hydrochlorothiazide, Process III IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2012-044 - Rev 02 2023/09/26 Valid Chemical 2023/09/26 Minor revision|CEP granted|26/09/2023;
Major revision|CEP granted|28/11/2022
1075 Budesonide, Process 2, non-micronised and micronised FERMION OY Espoo FI 100011508;100020280 CEP 2023-192 - Rev 00 2023/09/26 Valid 26/09/2028 Chemical 2023/09/26 New application|CEP granted|26/09/2023
2097 Mebeverine hydrochloride SYNTHOKEM LABS PRIVATE LIMITED Hyderabad IN 100018775;100027570 CEP 2021-271 - Rev 00 2023/09/25 Valid 25/09/2028 Chemical 2023/09/25 New application|CEP granted|25/09/2023
2422 Oseltamivir phosphate HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2018-046 - Rev 01 2023/09/25 Valid 28/04/2025 Chemical 2023/09/25 Minor revision|CEP granted|25/09/2023;
Minor revision|Accepted - CEP remains valid|05/01/2022
2270 Sildenafil citrate Zhejiang Jiuzhou Pharmaceutical Co., Ltd. Taizhou City CN 100011841;100018560 CEP 2013-332 - Rev 04 2023/09/22 Valid Chemical 2023/09/22 Administrative procedure|CEP granted|22/09/2023;
Notification|CEP granted|21/06/2023;
Notification|CEP granted|23/09/2022;
Transfer of holdership|CEP granted|19/05/2022;
Renewal|CEP granted|22/02/2022

数据库说明:

当前数据更新日期:2024年08月17日。
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