欧洲药典适用性证书数据库（欧盟CEP认证）

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	证书类型	上一程序的结束日期	历史数据程序类型\|结论\|日期
1009	Domperidone	SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN	100015104;100023787	CEP 1997-094 - Rev 10	2024/12/20	Valid		Chemical	2024/12/20	Notification\|CEP granted\|20/12/2024; Monograph revision\|Accepted - CEP remains valid\|02/09/2022
1973	Cineole	DÜLLBERG KONZENTRA GMBH & CO. KG Hamburg DE	100022402;100031085	CEP 2023-198 - Rev 01	2024/12/20	Valid	13/11/2029	Chemical	2024/12/20	Minor revision\|CEP granted\|20/12/2024; New application\|CEP granted\|13/11/2024
1009	Domperidone, Process II	SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN	100015104;100023787	CEP 2022-374 - Rev 01	2024/12/20	Valid	16/01/2028	Chemical	2024/12/20	Notification\|CEP granted\|20/12/2024; New application\|CEP granted\|16/01/2023
1008	Domperidone maleate	SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN	100015104;100023787	CEP 2003-069 - Rev 06	2024/12/20	Valid		Chemical	2024/12/20	Notification\|CEP granted\|20/12/2024; Monograph revision\|CEP granted\|10/10/2022; Minor revision\|CEP granted\|30/04/2020
3095	Dabigatran etexilate mesilate, Crystalline Form-I, micronised and non-micronised	MSN LIFE SCIENCES PRIVATE LIMITED Chandampet Village IN	100018316;100027671	CEP 2024-026 - Rev 00	2024/12/20	Valid	20/12/2029	Chemical	2024/12/20	New application\|CEP granted\|20/12/2024
2244	Tacrolimus monohydrate	Chunghwa Chemical Synthesis & Biotech Co., Ltd. Shu-Lin TW	100011999;100018609	CEP 2018-241 - Rev 02	2024/12/20	Valid		Chemical	2024/12/20	Renewal\|CEP granted\|20/12/2024; Minor revision\|CEP granted\|30/03/2023; Notification\|Accepted - CEP remains valid\|02/11/2020
1455	Ofloxacin	DAIICHI SANKYO CO., LTD. Tokyo JP	100025092;100034274	CEP 2003-210 - Rev 04	2024/12/20	Valid		Chemical	2024/12/20	Minor revision\|CEP granted\|20/12/2024; Notification\|Accepted - CEP remains valid\|27/01/2022; Monograph revision\|Accepted - CEP remains valid\|02/09/2021
2531	Clopidogrel hydrogen sulfate, Form I	ZYDUS LIFESCIENCES LIMITED Vadodara IN	100005979;100074301	CEP 2011-152 - Rev 04	2024/12/20	Valid		Chemical	2024/12/20	Minor revision\|CEP granted\|20/12/2024; Major revision\|CEP granted\|28/04/2023; Notification\|CEP granted\|07/07/2022; Minor revision\|Accepted - CEP remains valid\|29/06/2020
2071	Milk thistle dry extract, refined and standardised, DER 24-27:1	TAPI CZECH INDUSTRIES S.R.O. Opava CZ	100051642;100090678	CEP 2017-262 - Rev 02	2024/12/19	Valid		Herbal	2024/12/19	Renewal\|CEP granted\|19/12/2024; Monograph revision\|Accepted - CEP remains valid\|15/03/2024; Minor revision\|CEP granted\|04/02/2021
49	Paracetamol	ANQIU LU'AN PHARMACEUTICAL CO., LTD. Weifang CN	100020492;100094456	CEP 2000-124 - Rev 12	2024/12/19	Valid		Chemical	2024/12/19	Minor revision\|CEP granted\|19/12/2024; Administrative procedure\|CEP granted\|29/07/2024; Notification\|CEP granted\|11/07/2022; Monograph revision\|Accepted - CEP remains valid\|27/04/2022; Minor revision\|CEP granted\|07/09/2021
2779	Solifenacin succinate, Process-II	MICRO LABS LIMITED Bengaluru IN	100017819;100077269	CEP 2021-510 - Rev 01	2024/12/19	Valid	20/06/2027	Chemical	2024/12/19	Major revision\|CEP granted\|19/12/2024; Minor revision\|Accepted - CEP remains valid\|05/07/2024; New application\|CEP granted\|20/06/2022
2815	Entecavir monohydrate	BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO., LTD. Suzhou CN	100011974;100021627	CEP 2018-283 - Rev 01	2024/12/19	Valid	19/06/2025	Chemical	2024/12/20	Minor revision\|CEP granted\|20/12/2024; Notification\|Accepted - CEP remains valid\|06/05/2022
101	Nitrofurantoin, Macrocrystals, Anhydrate Form β	ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN	100006039;100002980	CEP 2022-297 - Rev 00	2024/12/19	Valid	19/12/2029	Chemical	2024/12/20	New application\|CEP granted\|20/12/2024
1407	Ciclopirox	OLON S.P.A. Rodano IT	100012085;100019537	CEP 2015-365 - Rev 01	2024/12/19	Valid		Chemical	2024/12/20	Minor revision\|CEP granted\|20/12/2024; Minor revision\|Accepted - CEP remains valid\|09/05/2023; Renewal\|CEP granted\|14/01/2022; Minor revision\|CEP granted\|08/04/2021
1002	Diclofenac sodium	YUNG ZIP CHEMICAL IND. CO., LTD. Taichung TW	100023062;100031811	CEP 2018-016 - Rev 03	2024/12/19	Valid		Chemical	2024/12/20	Renewal\|CEP granted\|20/12/2024; Minor revision\|CEP granted\|16/08/2022; Minor revision\|CEP granted\|23/09/2021
1386	Albendazole	SEQUENT SCIENTIFIC LIMITED Mumbai IN	100017805;100032372	CEP 2005-010 - Rev 05	2024/12/19	Valid		Chemical	2024/12/20	Minor revision\|CEP granted\|20/12/2024; Notification\|Rejected\|25/11/2024; Minor revision\|CEP granted\|24/07/2024; Minor revision\|Accepted - CEP remains valid\|29/09/2021; Minor revision\|CEP granted\|21/12/2020
2932	Rivaroxaban, Process II, Non-micronised and Micronised	QUIMICA SINTETICA S.A. Alcala De Henares ES	100012121;100019020	CEP 2024-329 - Rev 00	2024/12/19	Valid	19/12/2029	Chemical	2024/12/20	New application\|CEP granted\|20/12/2024
625	Sodium alginate	QINGDAO HYZLIN BIOLOGY DEVELOPMENT CO., LTD. Qingdao CN	100049753;100086741	CEP 2023-182 - Rev 00	2024/12/19	Valid	19/12/2029	Chemical	2024/12/20	New application\|CEP granted\|20/12/2024
1324	Flecainide acetate	OMSAV PHARMA RESEARCH PRIVATE LIMITED Mumbai IN	100050205;100087649	CEP 2022-323 - Rev 00	2024/12/19	Valid	19/12/2029	Chemical	2024/12/20	New application\|CEP granted\|20/12/2024
1286	Alfacalcidol	NANJING HERON PHARMACEUTICAL Co., Ltd. Nanjing CN	100050591;100088354	CEP 2024-060 - Rev 00	2024/12/19	Valid	19/12/2029	Chemical and TSE	2024/12/20	New application\|CEP granted\|20/12/2024

专论编号 (Monograph Number)
物质名称 (Substance)
证书持有人 (Certificate (CEP) Holder)
证书编号 (Certificate (CEP) Number)
证书类型 (Type CEP)
证书状态 (Status CEP)
发布日期(Issue Date CEP)	-
证书效期(End date CEP)	-