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
2856	Pirfenidone, Process II	HONOUR LAB LIMITED Hyderabad IN	100011891;100097835	CEP 2025-392 - Rev 00	2025/12/22	Valid	22/12/2030	Chemical	2025/12/22	New application\|CEP granted\|22/12/2025
1075	Budesonide, Micronised, non-micronised	MINAKEM Dunkerque FR	100032366;100056463	CEP 2010-190 - Rev 04	2025/12/22	Valid		Chemical	2025/12/22	Minor revision\|CEP granted\|22/12/2025; Minor revision\|Accepted - CEP remains valid\|29/08/2024; Minor revision\|Accepted - CEP remains valid\|17/02/2023; Notification\|Accepted - CEP remains valid\|03/06/2021; Minor revision\|CEP granted\|09/06/2020
2606	Tadalafil, Form-I, Micronised, Non-micronised, Milled and Non-milled	MSN ORGANICS PRIVATE LIMITED Bibinagar Village IN	100012074;100018617	CEP 2011-366 - Rev 01	2025/12/22	Valid		Chemical	2025/12/22	Minor revision\|CEP granted\|22/12/2025; Minor revision\|Accepted - CEP remains valid\|01/03/2022
194	Sodium dihydrogen phosphate dihydrate	DR. PAUL LOHMANN GMBH & CO. KGAA Emmerthal DE	100022728;100031429	CEP 2019-228 - Rev 02	2025/12/22	Valid		Chemical	2025/12/22	Renewal\|CEP granted\|22/12/2025; Minor revision\|CEP granted\|04/10/2023
2131	Tamsulosin hydrochloride	SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO., LTD. Luoyang Town CN	100020594;100034407	CEP 2024-421 - Rev 00	2025/12/22	Valid	22/12/2030	Chemical	2025/12/22	New application\|CEP granted\|22/12/2025
1970	Atracurium besilate, Manufacturing code: 55	CF PHARMA LTD. Budapest HU	100022980;100031712	CEP 2020-436 - Rev 03	2025/12/22	Valid		Chemical	2025/12/22	Renewal\|CEP granted\|22/12/2025; Minor revision\|CEP granted\|25/01/2024; Minor revision\|Accepted - CEP remains valid\|01/02/2022; Minor revision\|Accepted - CEP remains valid\|18/11/2021; Administrative procedure\|CEP granted\|11/02/2021; New application\|CEP granted\|08/01/2021
1346	Metamizole sodium monohydrate	EUROAPI GERMANY GmbH Frankfurt am Main DE	100039255;100061797	CEP 2000-277 - Rev 07	2025/12/22	Valid		Chemical	2025/12/22	Minor revision\|CEP granted\|22/12/2025; Minor revision\|Accepted - CEP remains valid\|27/03/2023; Transfer of holdership\|CEP granted\|10/12/2021
565	Sodium nitroprusside	HAINAN POLY PHARMACEUTICAL COMPANY LIMITED Haikou CN	100024397;100033569	CEP 2020-114 - Rev 02	2025/12/22	Valid		Chemical	2025/12/22	Renewal\|CEP granted\|22/12/2025; Minor revision\|CEP granted\|14/03/2022; New application\|CEP granted\|12/04/2021
890	Clonazepam, Non-micronised, micronised	F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT	100011866;100022277	CEP 2013-037 - Rev 02	2025/12/22	Valid		Chemical	2025/12/22	Minor revision\|CEP granted\|22/12/2025; Minor revision\|Accepted - CEP remains valid\|04/02/2025; Minor revision\|Accepted - CEP remains valid\|05/09/2024; Minor revision\|CEP granted\|23/11/2022; Renewal\|CEP granted\|07/08/2020
2574	Entacapone	COHANCE LIFESCIENCES LIMITED Mumbai IN	100011755;100090273	CEP 2010-337 - Rev 04	2025/12/22	Valid		Chemical	2025/12/22	Major revision\|CEP granted\|22/12/2025; Notification\|CEP granted\|15/12/2022; Notification\|CEP granted\|23/11/2022; Minor revision\|CEP granted\|20/06/2022
210	Tetracycline hydrochloride	CIPAN - COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS, S.A. Castanheira do Ribatejo PT	100021412;100078598	CEP 2012-171 - Rev 02	2025/12/22	Valid		Chemical	2025/12/22	Minor revision\|CEP granted\|22/12/2025; Minor revision\|CEP granted\|10/11/2022
2191	Atorvastatin calcium, Process-III	ZYDUS LIFESCIENCES LIMITED Vadodara IN	100005979;100074301	CEP 2020-309 - Rev 02	2025/12/22	Valid		Chemical	2025/12/22	Renewal\|CEP granted\|22/12/2025; Monograph revision\|CEP granted\|26/07/2022; New application\|CEP granted\|19/02/2021
1009	Domperidone, Process II	VASUDHA PHARMA CHEM LIMITED Hyderabad IN	100011811;100018603	CEP 2020-315 - Rev 02	2025/12/22	Valid		Chemical	2025/12/22	Renewal\|CEP granted\|22/12/2025; Notification\|CEP granted\|31/01/2023; Monograph revision\|Accepted - CEP remains valid\|26/08/2022; New application\|CEP granted\|28/01/2021
572	Timolol maleate	CENTAUR PHARMACEUTICALS PRIVATE LIMITED Mumbai IN	100018245;100028824	CEP 2010-084 - Rev 04	2025/12/22	Valid		Chemical	2025/12/22	Minor revision\|CEP granted\|22/12/2025; Notification\|CEP granted\|20/10/2023
2223	Glimepiride	SHANDONG XINHUA PHARMACEUTICAL CO., LTD. Zibo CN	100011788;100019607	CEP 2023-111 - Rev 00	2025/12/22	Valid	22/12/2030	Chemical	2025/12/22	New application\|CEP granted\|22/12/2025
38	Levodopa	ZHEJIANG YONGTAI CHIRAL MEDICINE TECHNOLOGY CO. LTD. Taizhou CN	100041319;100068021	CEP 2024-527 - Rev 00	2025/12/22	Valid	22/12/2030	Chemical	2025/12/22	New application\|CEP granted\|22/12/2025
2541	Quetiapine Fumarate, Process-B	HIKAL LIMITED Bengaluru IN	100014769;100023445	CEP 2024-272 - Rev 01	2025/12/22	Valid	27/09/2029	Chemical	2025/12/22	Minor revision\|CEP granted\|22/12/2025; New application\|CEP granted\|27/09/2024
2768	Fluticasone furoate, Micronised	AURISCO PHARMACEUTICAL CO., LTD. Tiantai CN	100011968;100018590	CEP 2022-238 - Rev 01	2025/12/22	Valid	07/09/2028	Chemical	2025/12/22	Minor revision\|CEP granted\|22/12/2025; New application\|CEP granted\|07/09/2023
3139	Brivaracetam	CHENGDA PHARMACEUTICALS CO., LTD. Jiashan CN	100012006;100020624	CEP 2024-227 - Rev 00	2025/12/22	Valid	22/12/2030	Chemical	2025/12/22	New application\|CEP granted\|22/12/2025
2778	Sitagliptin phosphate monohydrate	WAVELENGTH ENTERPRISES LTD. Petah Tikva IL	100018877;100092992	CEP 2024-213 - Rev 00	2025/12/22	Valid	22/12/2030	Chemical	2025/12/22	New application\|CEP granted\|22/12/2025

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)	-