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
2629	Rivastigmine	Erregierre S.p.A. San Paolo D'Argon IT	100012035;100021179	CEP 2025-073 - Rev 00	2026/02/25	Valid	25/02/2031	Chemical	2026/02/25	New application\|CEP granted\|25/02/2026
1012	Famotidine	HALEOS LABS LIMITED Hyderabad IN	100039495;100077080	CEP 2023-455 - Rev 01	2026/02/25	Valid	03/09/2030	Chemical	2026/02/25	Notification\|CEP granted\|25/02/2026; New application\|CEP granted\|03/09/2025
803	Amiodarone hydrochloride	EMCURE PHARMACEUTICALS LIMITED Pune IN	100011677;100099996	CEP 2024-451 - Rev 00	2026/02/25	Valid	25/02/2031	Chemical	2026/02/25	New application\|CEP granted\|25/02/2026
3078	Riociguat, Micronised	MICRO LABS LIMITED Bengaluru IN	100017819;100077269	CEP 2025-423 - Rev 00	2026/02/25	Valid	25/02/2031	Chemical	2026/02/25	New application\|CEP granted\|25/02/2026
1611	Diosmin, Chenxiang site, micronised and non-micronised	CHENGDU YAZHONG BIO-PHARMACEUTICAL CO., LTD. Pengzhou CN	100048965;100095919	CEP 2025-251 - Rev 01	2026/02/25	Valid	15/07/2030	Chemical	2026/02/25	Minor revision\|CEP granted\|25/02/2026; New application\|CEP granted\|15/07/2025
823	Etoposide	SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou CN	100014777;100050265	CEP 2025-052 - Rev 00	2026/02/25	Valid	25/02/2031	Chemical	2026/02/25	New application\|CEP granted\|25/02/2026
3049	Etonogestrel, Micronised and non-micronised	ASPEN OSS B.V. Oss NL	100011619;100050602	CEP 2024-341 - Rev 00	2026/02/25	Valid	25/02/2031	Chemical	2026/02/25	New application\|CEP granted\|25/02/2026
2777	Pregabalin	HIKAL LIMITED Bengaluru IN	100014769;100023445	CEP 2016-181 - Rev 03	2026/02/25	Valid		Chemical	2026/02/25	Minor revision\|CEP granted\|25/02/2026; Minor revision\|CEP granted\|28/06/2023; Notification\|CEP granted\|07/09/2022; Renewal\|CEP granted\|15/06/2022; Minor revision\|Accepted - CEP remains valid\|20/12/2021; Minor revision\|CEP granted\|18/03/2021; Major revision\|CEP granted\|24/11/2020; Notification\|Accepted - CEP remains valid\|15/07/2020
2306	Gemcitabine hydrochloride, GA process	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2022-499 - Rev 01	2026/02/25	Valid	28/02/2028	Chemical	2026/02/25	Major revision\|CEP granted\|25/02/2026; New application\|CEP granted\|28/02/2023
2191	Atorvastatin calcium, Crystalline	BIOCON LIMITED Bengaluru IN	100011487;100018595	CEP 2011-009 - Rev 05	2026/02/25	Valid		Chemical	2026/02/25	Minor revision\|CEP granted\|25/02/2026; Notification\|Accepted - CEP remains valid\|11/09/2025; Major revision\|CEP granted\|03/12/2024; Monograph revision\|CEP granted\|08/12/2022; Major revision\|CEP granted\|22/04/2021; Minor revision\|Rejected\|26/10/2020; Minor revision\|CEP granted\|18/06/2020
168	Ampicillin trihydrate, Enzymatic route	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2022-482 - Rev 03	2026/02/25	Valid	06/06/2028	Chemical	2026/02/25	Minor revision\|CEP granted\|25/02/2026; Administrative procedure\|CEP granted\|28/11/2023; Notification\|CEP granted\|21/11/2023; New application\|CEP granted\|06/06/2023
2270	Sildenafil citrate	HALEOS LABS LIMITED Hyderabad IN	100039495;100077080	CEP 2022-249 - Rev 01	2026/02/25	Valid	28/02/2029	Chemical	2026/02/25	Notification\|CEP granted\|25/02/2026; New application\|CEP granted\|28/02/2024
576	Allopurinol	HALEOS LABS LIMITED Hyderabad IN	100039495;100077080	CEP 2021-239 - Rev 02	2026/02/25	Valid	09/03/2028	Chemical	2026/02/25	Notification\|CEP granted\|25/02/2026; Minor revision\|CEP granted\|17/07/2024; New application\|CEP granted\|09/03/2023
1681	Tramadol hydrochloride	EMNAR PHARMA PRIVATE LIMITED Hyderabad IN	100033980;100065255	CEP 2013-320 - Rev 03	2026/02/25	Valid		Chemical	2026/02/25	Minor revision\|CEP granted\|25/02/2026; Notification\|CEP granted\|27/10/2023; Major revision\|CEP granted\|03/02/2022; Minor revision\|Rejected\|19/07/2021; Renewal\|CEP granted\|10/08/2020
928	Lomustine	DR. REDDY'S LABORATORIES LIMITED Hyderabad IN	100003991;100000217	CEP 2009-141 - Rev 04	2026/02/23	Valid		Chemical	2026/02/23	Minor revision\|CEP granted\|23/02/2026; Notification\|Rejected\|12/01/2026; Minor revision\|CEP granted\|16/08/2024; Minor revision\|Accepted - CEP remains valid\|25/02/2021
464	Amitriptyline hydrochloride	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2001-432 - Rev 07	2026/02/23	Valid		Chemical	2026/02/23	Major revision\|CEP granted\|23/02/2026; Notification\|CEP granted\|11/03/2025; Minor revision\|CEP granted\|07/05/2024; Notification\|Accepted - CEP remains valid\|05/07/2023; Notification\|Accepted - CEP remains valid\|02/08/2022; Notification\|CEP granted\|04/02/2022; Minor revision\|Accepted - CEP remains valid\|12/10/2021; Notification\|Rejected\|16/08/2021
417	Oxygen	LINDE GMBH Pullach I. Isartal DE	100017889;100043514	CEP 2019-005 - Rev 06	2026/02/23	Valid		Chemical	2026/02/23	Notification\|CEP granted\|23/02/2026; Renewal\|Accepted - CEP remains valid\|31/01/2025; Notification\|CEP granted\|05/06/2024; Minor revision\|CEP granted\|09/02/2024; Notification\|Accepted - CEP remains valid\|12/12/2022; Minor revision\|CEP granted\|11/04/2022; Notification\|CEP granted\|21/01/2021; Notification\|CEP granted\|30/10/2020
2131	Tamsulosin hydrochloride	COHANCE LIFESCIENCES LIMITED Mumbai IN	100011755;100090273	CEP 2007-014 - Rev 06	2026/02/23	Valid		Chemical	2026/02/23	Notification\|CEP granted\|23/02/2026; Notification\|CEP granted\|15/05/2020
809	Betamethasone dipropionate, Micronised	TARO PHARMACEUTICAL INDUSTRIES, LTD. Haifa IL	100004559;100001120	CEP 2018-018 - Rev 04	2026/02/23	Valid		Chemical	2026/02/18	Minor revision\|CEP granted\|18/02/2026; Minor revision\|CEP granted\|19/05/2025; Renewal\|CEP granted\|19/03/2024
417	Oxygen	SOL S.P.A. Monza IT	100002061;100001723	CEP 2020-295 - Rev 01	2026/02/23	Valid		Chemical	2026/02/23	Renewal\|CEP granted\|23/02/2026; New application\|CEP granted\|10/05/2021

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)	-