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
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
333 Heparin sodium SHENZHEN HEPALINK PHARMACEUTICAL GROUP CO., LTD. Shenzhen City CN 100012154;100018639 CEP 2006-059 - Rev 16 2023/09/26 Valid Chemical 2023/09/26 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
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
2064 Chondroitin sulfate sodium BIOIBERICA, S.A.U. Palafolls ES 100000136;100043853 CEP 2023-243 - Rev 00 2023/09/25 Valid 25/09/2028 Chemical and TSE 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
2675 Irinotecan hydrochloride trihydrate FERMION OY Espoo FI 100011508;100020280 CEP 2017-236 - Rev 02 2023/09/22 Valid Chemical 2023/09/22 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 2023/09/22 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
996 Clindamycin phosphate ZHEJIANG TIANTAI PHARMACEUTICAL CO., LTD. Taizhou City CN 100011852;100018559 CEP 2003-060 - Rev 06 2023/09/22 Valid Chemical 2023/09/22 Minor revision|CEP granted|22/09/2023;
Notification|Accepted - CEP remains valid|18/11/2021;
Minor revision|Accepted - CEP remains valid|23/06/2020
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 Chemical 2023/09/20 Minor revision|CEP granted|20/09/2023;
New application|CEP granted|13/07/2021
1352 Omega-3-acid triglycerides, SF07200, with tocopherols CRODA EUROPE LIMITED Leek GB 100015909;100024641 CEP 2007-366 - Rev 02 2023/09/20 Valid Chemical 2023/09/20 Minor revision|CEP granted|20/09/2023;
Monograph revision|Accepted - CEP remains valid|15/12/2020

数据库说明:

当前数据更新日期:2023年10月03日。
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