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
1084	Cetirizine dihydrochloride	GRANULES INDIA LIMITED Hyderabad IN	100011671;100097387	CEP 2009-349 - Rev 03	2025/08/25	Valid		Chemical	2025/08/25	Notification\|CEP granted\|25/08/2025; Minor revision\|Accepted - CEP remains valid\|27/06/2025; Minor revision\|CEP granted\|16/10/2024
1420	Enalapril maleate	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2003-078 - Rev 15	2025/08/25	Valid		Chemical	2025/08/25	Minor revision\|CEP granted\|25/08/2025; Minor revision\|Accepted - CEP remains valid\|03/10/2023; Minor revision\|CEP granted\|07/06/2023; Notification\|CEP granted\|24/03/2023; Notification\|CEP granted\|07/09/2021; Notification\|CEP granted\|04/09/2020
272	Doxycycline hyclate	YANCHENG SUHAI PHARMACEUTICAL CO., LTD. Dafeng District, Yancheng City CN	100024955;100058861	CEP 1999-100 - Rev 06	2025/08/25	Valid		Chemical	2025/08/25	Minor revision\|CEP granted\|25/08/2025; Major revision\|CEP granted\|06/05/2022
2296	Pantoprazole sodium sesquihydrate	RAKSHIT PHARMACEUTICALS LIMITED Anakapalli District IN	100039283;100061839	CEP 2014-060 - Rev 04	2025/08/25	Valid		Chemical	2025/08/25	Minor revision\|CEP granted\|25/08/2025; Minor revision\|CEP granted\|01/03/2024; Notification\|CEP granted\|10/01/2023; Major revision\|CEP granted\|04/07/2022; Renewal\|CEP granted\|19/11/2021; Minor revision\|CEP granted\|09/03/2021
2856	Pirfenidone	GRANULES INDIA LIMITED Hyderabad IN	100011671;100097387	CEP 2016-288 - Rev 02	2025/08/25	Valid		Chemical	2025/08/25	Notification\|CEP granted\|25/08/2025; Notification\|CEP granted\|06/06/2024; Renewal\|CEP granted\|05/12/2022
1058	Vancomycin hydrochloride, Changhai site (lyophilized process)	ZHEJIANG MEDICINE CO., LTD. Shaoxing CN	100022357;100084942	CEP 2023-065 - Rev 01	2025/08/25	Valid	05/04/2028	Chemical	2025/08/25	Minor revision\|CEP granted\|25/08/2025; Monograph revision\|Accepted - CEP remains valid\|31/01/2025; New application\|CEP granted\|05/04/2023
2631	Rosuvastatin calcium, RS01	CTX LIFESCIENCES PVT. LIMITED Surat IN	100019102;100027863	CEP 2023-060 - Rev 01	2025/08/25	Valid	22/05/2028	Chemical	2025/08/25	Minor revision\|CEP granted\|25/08/2025; Notification\|Rejected\|08/08/2025; New application\|CEP granted\|22/05/2023
1058	Vancomycin hydrochloride, Changhai site (precipitated process)	ZHEJIANG MEDICINE CO., LTD. Shaoxing CN	100022357;100084942	CEP 2023-067 - Rev 02	2025/08/25	Valid	05/04/2028	Chemical	2025/08/25	Minor revision\|CEP granted\|25/08/2025; Monograph revision\|CEP granted\|03/02/2025; New application\|CEP granted\|05/04/2023
567	Procainamide Hydrochloride	BIOPHORE INDIA PHARMACEUTICALS PRIVATE LIMITED Hyderabad IN	100028906;100063062	CEP 2019-119 - Rev 02	2025/08/25	Valid	30/06/2026	Chemical	2025/08/25	Monograph revision\|CEP granted\|25/08/2025; Notification\|CEP granted\|15/05/2023
1718	Diclazuril for veterinary use	ALIVIRA ANIMAL HEALTH LIMITED Visakhapatnam IN	100033528;100052489	CEP 2019-083 - Rev 03	2025/08/25	Valid		Chemical	2025/08/25	Renewal\|CEP granted\|25/08/2025; Monograph revision\|CEP granted\|02/05/2023; Minor revision\|CEP granted\|08/09/2021
2932	Rivaroxaban	DIVI'S LABORATORIES LIMITED Hyderabad IN	100011666;100052116	CEP 2024-266 - Rev 00	2025/08/25	Valid	25/08/2030	Chemical	2025/08/25	New application\|CEP granted\|25/08/2025
2630	Rivastigmine hydrogen tartrate	CIPLA LIMITED Mumbai IN	100006004;100018147	CEP 2014-053 - Rev 01	2025/08/22	Valid		Chemical	2025/08/22	Minor revision\|CEP granted\|22/08/2025; Renewal\|CEP granted\|25/10/2021
2866	Gefitinib	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2018-031 - Rev 02	2025/08/22	Valid		Chemical	2025/08/22	Minor revision\|CEP granted\|22/08/2025; Renewal\|CEP granted\|14/10/2024; Minor revision\|Accepted - CEP remains valid\|14/02/2022
2191	Atorvastatin calcium	AMOLI ORGANICS PRIVATE LIMITED Mumbai IN	100016500;100025303	CEP 2014-206 - Rev 03	2025/08/22	Valid		Chemical	2025/08/22	Major revision\|CEP granted\|22/08/2025; Minor revision\|CEP granted\|23/03/2023; Monograph revision\|Accepted - CEP remains valid\|20/07/2022; Minor revision\|CEP granted\|01/02/2022; Renewal\|CEP granted\|09/06/2021
654	Beclometasone dipropionate	CIPLA LIMITED Mumbai IN	100006004;100018147	CEP 2005-015 - Rev 05	2025/08/22	Valid		Chemical	2025/08/22	Minor revision\|CEP granted\|22/08/2025
1094	Cyproterone acetate	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2000-046 - Rev 06	2025/08/21	Valid		Chemical	2025/08/21	Minor revision\|CEP granted\|21/08/2025; Notification\|CEP granted\|10/03/2025; Notification\|CEP granted\|23/11/2021; Minor revision\|CEP granted\|11/09/2020
941	Nortriptyline hydrochloride	R.L. FINE CHEM PRIVATE LIMITED Chikkaballapur IN	100016723;100053383	CEP 2014-032 - Rev 03	2025/08/21	Valid		Chemical	2025/08/21	Minor revision\|CEP granted\|21/08/2025; Minor revision\|CEP granted\|28/06/2024; Minor revision\|CEP granted\|14/04/2021; Renewal\|CEP granted\|08/12/2020
1681	Tramadol hydrochloride	ZYDUS LIFESCIENCES LIMITED Vadodara IN	100005979;100074301	CEP 2004-098 - Rev 06	2025/08/21	Valid		Chemical	2025/08/21	Minor revision\|CEP granted\|21/08/2025; Minor revision\|CEP granted\|16/07/2024; Notification\|CEP granted\|07/07/2022; Minor revision\|CEP granted\|29/09/2021
942	Omeprazole, Process II	DR. REDDY'S LABORATORIES LIMITED Hyderabad IN	100003991;100000217	CEP 2011-228 - Rev 03	2025/08/21	Valid		Chemical	2025/08/21	Minor revision\|CEP granted\|21/08/2025
1058	Vancomycin hydrochloride	XELLIA PHARMACEUTICALS APS Copenhagen S DK	100004144;100002734	CEP 1996-006 - Rev 11	2025/08/21	Valid		Chemical	2025/08/21	Minor revision\|CEP granted\|21/08/2025; Minor revision\|Accepted - CEP remains valid\|20/08/2024; Notification\|Accepted - CEP remains valid\|01/03/2023; Minor revision\|Accepted - CEP remains valid\|20/04/2022; Minor revision\|Accepted - CEP remains valid\|04/02/2021

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)	-