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
402 Magnesium chloride hexahydrate Merck KGaA Darmstadt DE 100000742;100006955 CEP 2010-194 - Rev 02 2024/04/30 Valid Chemical 2024/04/30 Minor revision|CEP granted|30/04/2024;
Notification|Accepted - CEP remains valid|01/07/2022
992 Cefuroxime sodium, Sterile Qilu Antibiotics Pharmaceutical Co., Ltd. Jinan CN 100033695;100052910 CEP 2006-014 - Rev 03 2024/04/30 Valid Chemical 2024/04/30 Major revision|CEP granted|30/04/2024;
Minor revision|Accepted - CEP remains valid|10/06/2022;
Major revision|CEP granted|16/12/2021;
Minor revision|Rejected|05/08/2021;
Minor revision|CEP granted|01/03/2021;
Major revision|Abandoned|09/10/2020
2254 Moxifloxacin hydrochloride, Anhydrous MSN PHARMACHEM PRIVATE LIMITED Sangareddy District IN 100014794;100023345 CEP 2015-360 - Rev 02 2024/04/30 Valid Chemical 2024/04/30 Minor revision|CEP granted|30/04/2024;
Minor revision|CEP granted|07/09/2023;
Minor revision|Accepted - CEP remains valid|19/08/2022;
Renewal|CEP granted|22/03/2021
1472 Sodium hyaluronate, GS-120, intrinsic viscosity: 1.7 m3/kg; from fermentation; for parenteral administration, including intra-ocular use KIKKOMAN BIOCHEMIFA COMPANY Noda City JP 100039417;100087689 CEP 2023-034 - Rev 01 2024/04/30 Valid 21/06/2028 Chemical 2024/04/30 Minor revision|CEP granted|30/04/2024;
New application|CEP granted|21/06/2023
760 Cytarabine MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN 100023737;100061579 CEP 2012-251 - Rev 02 2024/04/30 Valid Chemical 2024/04/30 Administrative procedure|CEP granted|30/04/2024;
Minor revision|CEP granted|19/05/2022;
Minor revision|Accepted - CEP remains valid|19/07/2021;
Minor revision|Rejected|19/03/2021
2637 Pemetrexed disodium heptahydrate MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN 100023737;100061579 CEP 2015-141 - Rev 01 2024/04/30 Valid Chemical 2024/04/30 Administrative procedure|CEP granted|30/04/2024;
Monograph revision|Accepted - CEP remains valid|03/10/2023;
Renewal|CEP granted|04/01/2022
626 Neostigmine metilsulfate MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN 100023737;100061579 CEP 2019-024 - Rev 01 2024/04/30 Valid 18/12/2025 Chemical 2024/04/30 Administrative procedure|CEP granted|30/04/2024
2675 Irinotecan hydrochloride trihydrate MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN 100023737;100061579 CEP 2018-063 - Rev 01 2024/04/30 Valid 17/01/2025 Chemical 2024/04/30 Administrative procedure|CEP granted|30/04/2024;
Minor revision|Accepted - CEP remains valid|01/03/2022
2196 Bicalutamide MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN 100023737;100061579 CEP 2019-329 - Rev 01 2024/04/30 Valid 11/06/2026 Chemical 2024/04/30 Administrative procedure|CEP granted|30/04/2024
823 Etoposide MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN 100023737;100061579 CEP 2020-074 - Rev 01 2024/04/30 Valid 25/07/2027 Chemical 2024/04/30 Administrative procedure|CEP granted|30/04/2024;
New application|CEP granted|25/07/2022
2787 Esomeprazole magnesium dihydrate, Micronised KRKA, d.d., Novo mesto Novo mesto SI 100000627;100009540 CEP 2018-035 - Rev 03 2024/04/30 Valid Chemical 2024/04/30 Renewal|CEP granted|30/04/2024;
Notification|CEP granted|05/01/2023;
Notification|CEP granted|26/01/2022;
Minor revision|Accepted - CEP remains valid|15/12/2020
2465 Irbesartan ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN 100012174;100018701 CEP 2012-233 - Rev 03 2024/04/30 Valid Chemical 2024/04/30 Minor revision|CEP granted|30/04/2024;
Minor revision|Accepted - CEP remains valid|01/09/2023;
Notification|Accepted - CEP remains valid|12/05/2023;
Minor revision|Accepted - CEP remains valid|03/06/2022;
Minor revision|CEP granted|23/07/2021;
Minor revision|Accepted - CEP remains valid|21/07/2020
809 Betamethasone dipropionate TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. Tianjin CN 100011805;100018616 CEP 2022-342 - Rev 00 2024/04/30 Valid 30/04/2029 Chemical 2024/04/30 New application|CEP granted|30/04/2024
2536 Milbemycin oxime for veterinary use Zhejiang Hisun Pharmaceutical Co., Ltd. Taizhou City CN 100011825;100018687 CEP 2021-391 - Rev 02 2024/04/30 Valid 26/07/2028 Chemical 2024/04/30 Administrative procedure|CEP granted|30/04/2024;
Minor revision|CEP granted|20/11/2023;
New application|CEP granted|26/07/2023
2125 Doxazosin mesilate, Form-I Chemische Fabrik Berg GmbH Bitterfeld-Wolfen DE 100014200;100020038 CEP 2022-316 - Rev 00 2024/04/29 Valid 29/04/2029 Chemical 2024/04/29 New application|CEP granted|29/04/2024
2923 Esomeprazole sodium SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2020-393 - Rev 01 2024/04/29 Valid 24/11/2027 Chemical 2024/04/29 Minor revision|CEP granted|29/04/2024;
Minor revision|Accepted - CEP remains valid|28/08/2023;
New application|CEP granted|24/11/2022
1120 Lisinopril dihydrate, Process II HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2016-197 - Rev 01 2024/04/29 Valid Chemical 2024/04/29 Minor revision|CEP granted|29/04/2024;
Minor revision|Accepted - CEP remains valid|09/06/2023;
Renewal|CEP granted|28/04/2022;
Minor revision|CEP granted|22/10/2020
2866 Gefitinib SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou City CN 100014777;100050265 CEP 2017-028 - Rev 01 2024/04/29 Valid Chemical 2024/04/29 Minor revision|CEP granted|29/04/2024;
Renewal|CEP granted|22/03/2023;
Notification|CEP granted|07/02/2020
1695 Granisetron hydrochloride WAVELENGTH ENTERPRISES LTD. Petah Tikva IL 100018877;100050444 CEP 2007-217 - Rev 04 2024/04/29 Valid Chemical 2024/04/29 Minor revision|CEP granted|29/04/2024;
Minor revision|Accepted - CEP remains valid|23/02/2023;
Notification|Accepted - CEP remains valid|14/06/2022;
Minor revision|CEP granted|30/03/2021
1882 Passionflower herb dry extract, DER: 4-6.5:1 EUROMED S.A. Mollet del Vallès ES 100014852;100023498 CEP 2015-351 - Rev 01 2024/04/29 Valid Herbal 2024/04/29 Monograph revision|CEP granted|29/04/2024;
Renewal|CEP granted|17/08/2021;
Monograph revision|CEP granted|24/02/2021

数据库说明:

当前数据更新日期:2024年05月02日。
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