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
2675 Irinotecan hydrochloride trihydrate FERMION OY Espoo FI 100011508;100020280 CEP 2017-236 - Rev 02 2023/09/22 Valid Chemical 2024/04/19 Notification|Accepted - CEP remains valid|19/04/2024;
Renewal|CEP granted|22/09/2023
1758 Moxonidine Farmak A.S. Olomouc CZ 100012043;100022687 CEP 2008-266 - Rev 03 2023/09/22 Valid Chemical 2024/08/02 Minor revision|Accepted - CEP remains valid|02/08/2024;
Major revision|CEP granted|22/09/2023
115 Benzylpenicillin (procaine) monohydrate, Lecithin coated (1%), sterile SANDOZ GMBH Kundl AT 100000546;100000450 CEP 1999-017 - Rev 05 2023/09/22 Valid Chemical 2023/09/22 Minor revision|CEP granted|22/09/2023;
Minor revision|Accepted - CEP remains valid|28/07/2022
2790 Clopidogrel besilate MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN 100011732;100018657 CEP 2017-143 - Rev 02 2023/09/22 Valid Chemical 2023/09/22 Renewal|CEP granted|22/09/2023
2223 Glimepiride, Process-II GLENMARK LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2022-481 - Rev 00 2023/09/22 Valid 22/09/2028 Chemical 2023/09/22 New application|CEP granted|22/09/2023
227 Lidocaine hydrochloride monohydrate SOCIETÀ ITALIANA MEDICINALI SCANDICCI S.I.M.S. S.R.L Reggello IT 100012503;100022784 CEP 2001-014 - Rev 04 2023/09/22 Valid Chemical 2023/09/22 Minor revision|CEP granted|22/09/2023
1422 Etodolac IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2008-175 - Rev 04 2023/09/21 Valid Chemical 2023/09/21 Minor revision|CEP granted|21/09/2023;
Notification|Accepted - CEP remains valid|26/06/2023;
Minor revision|CEP granted|22/10/2021;
Minor revision|Accepted - CEP remains valid|21/02/2020
1649 Azithromycin Nexchem Pharmaceutical Co., Ltd. Jinhua City CN 100021355;100036732 CEP 2021-069 - Rev 00 2023/09/20 Valid 20/09/2028 Chemical 2023/09/20 New application|CEP granted|20/09/2023
2778 Sitagliptin phosphate monohydrate ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN 100012174;100018701 CEP 2020-037 - Rev 01 2023/09/20 Valid 13/07/2026 Chemical 2023/09/20 Minor revision|CEP granted|20/09/2023;
New application|CEP granted|13/07/2021
394 Hydrochlorothiazide SUZHOU LIXIN PHARMACEUTICAL CO., LTD. Suzhou CN 100012102;100019568 CEP 2012-250 - Rev 02 2023/09/20 Valid Chemical 2023/09/20 Minor revision|CEP granted|20/09/2023;
Minor revision|CEP granted|14/02/2023;
Notification|Rejected|14/12/2022
1705 Sertraline hydrochloride, Form-II, Process-II HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2014-195 - Rev 02 2023/09/20 Valid Chemical 2023/09/20 Minor revision|CEP granted|20/09/2023;
Minor revision|CEP granted|24/05/2022;
Renewal|CEP granted|08/09/2020
2573 Candesartan cilexetil Jiangxi Synergy Pharmaceutical Co., Ltd. Fengxin CN 100020812;100083553 CEP 2013-007 - Rev 03 2023/09/20 Valid Chemical 2023/09/20 Notification|CEP granted|20/09/2023;
Notification|CEP granted|21/03/2023;
Minor revision|Accepted - CEP remains valid|01/09/2021;
Minor revision|CEP granted|24/11/2020;
Notification|Abandoned|09/10/2020
821 Estradiol hemihydrate, Micronised fine, non-micronised VALDEPHARM Val de Reuil FR 100011898;100018788 CEP 2009-241 - Rev 06 2023/09/20 Valid Chemical 2023/09/20 Major revision|CEP granted|20/09/2023;
Minor revision|CEP granted|25/05/2022;
Minor revision|CEP granted|06/10/2020
2125 Doxazosin mesilate MIDAS PHARMA GMBH Ingelheim am Rhein DE 100001328;100004656 CEP 2017-111 - Rev 03 2023/09/20 Valid Chemical 2023/09/20 Renewal|CEP granted|20/09/2023;
Notification|CEP granted|21/05/2021
260 Amoxicillin trihydrate, Powder and for Direct Compression SANDOZ GMBH Kundl AT 100000546;100000450 CEP 2023-277 - Rev 00 2023/09/18 Valid 18/09/2028 Chemical 2024/07/02 Minor revision|Accepted - CEP remains valid|02/07/2024;
Notification|Accepted - CEP remains valid|02/04/2024;
New application|CEP granted|18/09/2023
755 Carbidopa HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2022-358 - Rev 00 2023/09/18 Valid 18/09/2028 Chemical 2023/09/18 New application|CEP granted|18/09/2023
2287 Fluconazole VIRUPAKSHA ORGANICS LIMITED Hyderabad IN 100021606;100076961 CEP 2009-364 - Rev 01 2023/09/18 Valid Chemical 2023/09/18 Minor revision|CEP granted|18/09/2023
1756 Lamotrigine TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL 100000702;100060842 CEP 2011-178 - Rev 03 2023/09/18 Valid Chemical 2023/09/18 Minor revision|CEP granted|18/09/2023;
Notification|CEP granted|20/12/2021;
Notification|CEP granted|20/05/2021
68 Atropine sulfate MINSHENG GROUP SHAOXING PHARMACEUTICAL CO., LTD. Shaoxing CN 100023459;100032595 CEP 2016-112 - Rev 05 2023/09/18 Valid Chemical 2023/09/18 Administrative procedure|CEP granted|18/09/2023;
Renewal|CEP granted|12/09/2023;
Minor revision|CEP granted|29/06/2022
3014 Rotigotine WAVELENGTH ENTERPRISES LTD. Petah Tikva IL 100018877;100050444 CEP 2021-291 - Rev 01 2023/09/18 Valid 25/08/2028 Chemical 2024/04/30 Minor revision|Accepted - CEP remains valid|30/04/2024;
Administrative procedure|CEP granted|18/09/2023;
New application|CEP granted|25/08/2023

数据库说明:

当前数据更新日期:2024年08月17日。
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