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
312	Betamethasone	SHANDONG SIRUI PHARMACEUTICAL CO., LTD. Heze CN	100049295;100083729	CEP 2024-446 - Rev 00	2026/02/11	Valid	11/02/2031	Chemical	2026/02/11	New application\|CEP granted\|11/02/2026
2465	Irbesartan	VERDANT LIFE SCIENCES PRIVATE LIMITED Anakapalli IN	100048776;100081115	CEP 2023-281 - Rev 00	2026/02/11	Valid	11/02/2031	Chemical	2026/02/11	New application\|CEP granted\|11/02/2026
72	Cholecalciferol	DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH	100053293;100094111	CEP 2009-050 - Rev 05	2026/02/10	Valid		Chemical and TSE	2026/02/10	Notification\|CEP granted\|10/02/2026; Notification\|CEP granted\|21/07/2025; Minor revision\|CEP granted\|06/12/2024; Minor revision\|CEP granted\|20/03/2024
931	Metformin Hydrochloride	AARTI DRUGS LIMITED Mumbai IN	100014953;100023652	CEP 2015-250 - Rev 01	2026/02/10	Valid		Chemical	2026/02/10	Minor revision\|CEP granted\|10/02/2026; Notification\|Rejected\|05/01/2026; Minor revision\|Accepted - CEP remains valid\|19/12/2024; Renewal\|CEP granted\|18/07/2022; Monograph revision\|Accepted - CEP remains valid\|30/03/2020
2019	Perindopril tert-butylamine	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2008-009 - Rev 06	2026/02/10	Valid		Chemical	2026/02/10	Minor revision\|CEP granted\|10/02/2026; Minor revision\|CEP granted\|17/01/2024; Minor revision\|Accepted - CEP remains valid\|18/01/2023; Minor revision\|Accepted - CEP remains valid\|12/03/2021; Minor revision\|CEP granted\|11/01/2021; Monograph revision\|Accepted - CEP remains valid\|09/06/2020
1359	Pivmecillinam hydrochloride	FRESENIUS KABI IPSUM S.R.L. Cassina de' Pecchi IT	100015105;100057989	CEP 2004-262 - Rev 08	2026/02/10	Valid		Chemical	2026/02/10	Minor revision\|CEP granted\|10/02/2026; Notification\|Accepted - CEP remains valid\|22/05/2025; Minor revision\|CEP granted\|12/06/2024; Major revision\|CEP granted\|01/02/2023; Minor revision\|CEP granted\|17/01/2022; Notification\|CEP granted\|02/02/2021; Notification\|Accepted - CEP remains valid\|05/02/2020
2992	Lacosamide, Form-I	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2018-099 - Rev 04	2026/02/10	Valid		Chemical	2026/02/10	Minor revision\|CEP granted\|10/02/2026; Minor revision\|Accepted - CEP remains valid\|02/06/2025; Renewal\|CEP granted\|23/12/2024; Minor revision\|Accepted - CEP remains valid\|09/09/2022; Major revision\|CEP granted\|03/11/2021; Minor revision\|Rejected\|02/07/2021; Minor revision\|CEP granted\|31/08/2020
1491	Amlodipine besilate, ADP process	UNICHEM LABORATORIES LIMITED Mumbai IN	100005397;100093080	CEP 2024-371 - Rev 01	2026/02/10	Valid	28/05/2030	Chemical	2026/02/10	Monograph revision\|CEP granted\|10/02/2026; New application\|CEP granted\|28/05/2025
1681	Tramadol hydrochloride, Process-II	SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN	100008538;100018201	CEP 2020-141 - Rev 03	2026/02/10	Valid		Chemical	2026/02/10	Renewal\|CEP granted\|10/02/2026; Minor revision\|CEP granted\|14/06/2024; Minor revision\|CEP granted\|31/03/2021; New application\|CEP granted\|21/09/2020
1491	Amlodipine besilate, Synthesis B process B	EGIS Pharmaceuticals PLC Budapest X HU	100001091;100001662	CEP 2023-411 - Rev 01	2026/02/10	Valid	14/06/2029	Chemical	2026/02/10	Monograph revision\|CEP granted\|10/02/2026; New application\|CEP granted\|14/06/2024
1181	Buprenorphine hydrochloride	SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN	100008538;100018201	CEP 2009-312 - Rev 02	2026/02/09	Valid		Chemical	2026/02/09	Minor revision\|CEP granted\|09/02/2026; Minor revision\|CEP granted\|11/04/2025
533	Triamcinolone acetonide, Non-micronised, micronised	ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD. Taizhou CN	100022759;100031459	CEP 2024-259 - Rev 00	2026/02/09	Valid	09/02/2031	Chemical	2026/02/09	New application\|CEP granted\|09/02/2026
954	Temazepam	R.L. FINE CHEM PRIVATE LIMITED Chikkaballapur IN	100016723;100053383	CEP 2025-044 - Rev 00	2026/02/09	Valid	09/02/2031	Chemical	2026/02/09	New application\|CEP granted\|09/02/2026
2244	Tacrolimus monohydrate	Chunghwa Chemical Synthesis & Biotech Co., Ltd. Shu Lin TW	100011999;100018609	CEP 2018-241 - Rev 03	2026/02/06	Valid		Chemical	2026/02/06	Minor revision\|CEP granted\|06/02/2026; Renewal\|CEP granted\|20/12/2024; Minor revision\|CEP granted\|30/03/2023; Notification\|Accepted - CEP remains valid\|02/11/2020
312	Betamethasone	XI’AN GUOKANG RUIJIN PHARMACEUTICAL CO., LTD. Xi’an CN	100039231;100096104	CEP 2023-086 - Rev 00	2026/02/06	Valid	06/02/2031	Chemical	2026/02/06	New application\|CEP granted\|06/02/2026
2600	Olmesartan medoxomil, Process-II	AMOLI ORGANICS PRIVATE LIMITED Mumbai IN	100016500;100025303	CEP 2021-404 - Rev 02	2026/02/06	Valid	20/04/2027	Chemical	2026/02/06	Major revision\|CEP granted\|06/02/2026; Minor revision\|CEP granted\|22/02/2023; Notification\|Rejected\|27/01/2023; New application\|CEP granted\|20/04/2022
2423	Valsartan, VL Process Essentially Amorphous Form	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2021-152 - Rev 02	2026/02/06	Valid	25/04/2027	Chemical	2026/02/06	Minor revision\|CEP granted\|06/02/2026; Minor revision\|CEP granted\|01/12/2022; New application\|CEP granted\|25/04/2022
195	Sodium hydrogen carbonate	QEMETICA SODA DEUTSCHLAND GMBH & CO. KG Stassfurt DE	100033772;100053126	CEP 2024-486 - Rev 00	2026/02/06	Valid	06/02/2031	Chemical	2026/02/06	New application\|CEP granted\|06/02/2026
2423	Valsartan, (1582)	MACLEODS PHARMACEUTICALS LIMITED Mumbai IN	100021441;100077265	CEP 2025-145 - Rev 00	2026/02/06	Valid	06/02/2031	Chemical	2026/02/06	New application\|CEP granted\|06/02/2026
140	Ethinylestradiol	HUNAN KYF PHARMACEUTICAL CO., LTD Jinshi CN	100042971;100071054	CEP 2025-350 - Rev 00	2026/02/06	Valid	06/02/2031	Chemical	2026/02/06	New application\|CEP granted\|06/02/2026

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)	-