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
988	Cefazolin sodium, Sterile	ACS DOBFAR S.P.A. Tribiano IT	100011589;100019524	CEP 1996-083 - Rev 07	2025/12/16	Valid		Chemical	2025/12/16	Major revision\|CEP granted\|16/12/2025
578	Ampicillin sodium, Sterile	SANDOZ GMBH Kundl AT	100000546;100000450	CEP 1993-005 - Rev 10	2025/12/16	Valid		Chemical	2025/12/16	Minor revision\|CEP granted\|16/12/2025; Minor revision\|CEP granted\|30/07/2025; Minor revision\|Rejected\|26/08/2024; Monograph revision\|CEP granted\|21/02/2024; Minor revision\|Accepted - CEP remains valid\|30/06/2022; Notification\|Accepted - CEP remains valid\|01/07/2021
411	Sodium acetate trihydrate	Merck KGaA Darmstadt DE	100000742;100006955	CEP 2011-384 - Rev 02	2025/12/15	Valid		Chemical	2025/12/15	Notification\|CEP granted\|15/12/2025; Minor revision\|Accepted - CEP remains valid\|12/04/2024; Major revision\|CEP granted\|03/12/2021
572	Timolol maleate	PCAS Ecully FR	100011754;100054740	CEP 1996-049 - Rev 08	2025/12/15	Valid		Chemical	2025/12/15	Minor revision\|CEP granted\|15/12/2025; Minor revision\|CEP granted\|16/10/2023
2219	Lansoprazole	NIFTY LABS PRIVATE LIMITED Hyderabad IN	100014767;100042749	CEP 2010-297 - Rev 05	2025/12/15	Valid		Chemical	2025/12/15	Minor revision\|CEP granted\|15/12/2025; Notification\|CEP granted\|24/09/2025; Minor revision\|CEP granted\|26/03/2024; Notification\|CEP granted\|16/08/2022; Major revision\|CEP granted\|11/04/2022
2531	Clopidogrel hydrogen sulfate, Form-I	PRAVEEN LABORATORIES PRIVATE LIMITED Surat IN	100033525;100087439	CEP 2014-176 - Rev 02	2025/12/15	Valid		Chemical	2025/12/15	Minor revision\|CEP granted\|15/12/2025; Minor revision\|CEP granted\|21/02/2024; Renewal\|CEP granted\|05/11/2020
2154	Telmisartan, 315519	KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI	100000627;100009540	CEP 2021-254 - Rev 02	2025/12/15	Valid	08/12/2026	Chemical	2025/12/15	Notification\|CEP granted\|15/12/2025; Minor revision\|CEP granted\|01/09/2025; New application\|CEP granted\|08/12/2021
2420	Tiotropium bromide monohydrate	DEVA HOLDING A.Ş. Istanbul TR	100004235;100060052	CEP 2023-452 - Rev 00	2025/12/15	Valid	15/12/2030	Chemical	2025/12/15	New application\|CEP granted\|15/12/2025
1764	Rocuronium bromide	GLAND PHARMA LIMITED Visakhapatnam IN	100011664;100061750	CEP 2023-174 - Rev 00	2025/12/15	Valid	15/12/2030	Chemical	2025/12/15	New application\|CEP granted\|15/12/2025
2064	Chondroitin sulfate sodium	MDC PHARMACEUTICAL CO., LTD. Huaian CN	100024679;100033862	CEP 2025-189 - Rev 00	2025/12/15	Valid	15/12/2030	TSE	2025/12/15	New application\|CEP granted\|15/12/2025
1074	Biperiden hydrochloride	MAITHILI LIFE SCIENCES PRIVATE LIMITED Hyderabad IN	100042329;100073907	CEP 2021-360 - Rev 01	2025/12/15	Valid	31/10/2029	Chemical	2025/12/15	Administrative procedure\|CEP granted\|15/12/2025; New application\|CEP granted\|31/10/2024
1489	Ambroxol hydrochloride	SHIVALIK RASAYAN LIMITED New Delhi IN	100048259;100086954	CEP 2023-463 - Rev 00	2025/12/15	Valid	15/12/2030	Chemical	2025/12/15	New application\|CEP granted\|15/12/2025
931	Metformin Hydrochloride	SHANDONG SHOUGUANG BOKANG PHARMACEUTICAL CO., LTD. Yangkou Town CN	100048458;100080267	CEP 2019-141 - Rev 01	2025/12/12	Valid		Chemical	2025/12/12	Renewal\|CEP granted\|12/12/2025; Minor revision\|Rejected\|16/08/2022
2306	Gemcitabine hydrochloride	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2009-208 - Rev 03	2025/12/12	Valid		Chemical	2025/12/12	Minor revision\|CEP granted\|12/12/2025; Minor revision\|Accepted - CEP remains valid\|30/01/2024; Minor revision\|Accepted - CEP remains valid\|19/04/2022; Minor revision\|Accepted - CEP remains valid\|02/02/2022; Minor revision\|CEP granted\|02/11/2020
1454	Nonoxinol 9	SYENSQO USA LLC Spartanburg US	100038993;100061359	CEP 2007-327 - Rev 02	2025/12/12	Valid		Chemical	2025/12/12	Notification\|CEP granted\|12/12/2025; Minor revision\|CEP granted\|04/05/2022; Notification\|Rejected\|21/03/2022
534	Trimipramine maleate	LUNDBECK PHARMACEUTICALS ITALY S.P.A. Padova IT	100005981;100005944	CEP 2011-329 - Rev 01	2025/12/12	Valid		Chemical	2025/12/12	Minor revision\|CEP granted\|12/12/2025; Minor revision\|Accepted - CEP remains valid\|26/08/2024
1559	Risperidone	CHIERON ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN	100053345;100094249	CEP 2018-210 - Rev 02	2025/12/12	Valid		Chemical	2025/12/12	Renewal\|CEP granted\|12/12/2025; Notification\|CEP granted\|17/06/2025
2362	Rifaximin	LUOHE CHIEF PHARMACEUTICAL CO., LTD. Luohe City CN	100043312;100071644	CEP 2021-420 - Rev 01	2025/12/12	Valid	06/06/2028	Chemical	2025/12/12	Major revision\|CEP granted\|12/12/2025; New application\|CEP granted\|06/06/2023
2932	Rivaroxaban, Process-2, Symed Labs Limited Unit-I, 1RVS	SYMED LABS LIMITED Hyderabad IN	100018727;100090820	CEP 2025-385 - Rev 00	2025/12/12	Valid	12/12/2030	Chemical	2025/12/12	New application\|CEP granted\|12/12/2025
566	Penicillamine	FLEMING LABORATORIES LIMITED Hyderabad IN	100015641;100067279	CEP 2022-136 - Rev 01	2025/12/12	Valid	17/06/2029	Chemical	2025/12/12	Minor revision\|CEP granted\|12/12/2025; New application\|CEP granted\|17/06/2024

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)	-