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
1362	Prilocaine	NORTEC QUIMICA S.A. Duque de Caxias BR	100003647;100007647	CEP 2019-135 - Rev 01	2026/04/17	Valid		Chemical	2026/04/17	Renewal\|CEP granted\|17/04/2026
627	Nifedipine	SHOUGUANG FUKANG PHARMACEUTICAL CO., LTD. Shouguang CN	100017920;100052986	CEP 2022-402 - Rev 01	2026/04/17	Valid	22/04/2029	Chemical	2026/04/17	Monograph revision\|CEP granted\|17/04/2026; New application\|CEP granted\|22/04/2024
1800	Vincamine	LINNEA S.A. Locarno CH	100018975;100027746	CEP 2022-273 - Rev 01	2026/04/17	Valid	25/06/2029	Chemical	2026/04/17	Minor revision\|CEP granted\|17/04/2026; Minor revision\|Accepted - CEP remains valid\|03/03/2025; New application\|CEP granted\|25/06/2024
2777	Pregabalin, PEA Process	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy IN	100051463;100098142	CEP 2023-223 - Rev 02	2026/04/17	Valid	05/02/2029	Chemical	2026/04/17	Minor revision\|CEP granted\|17/04/2026; Minor revision\|Accepted - CEP remains valid\|10/03/2025; Notification\|CEP granted\|29/07/2024; New application\|CEP granted\|05/02/2024
2631	Rosuvastatin calcium, Process II	NINGBO MENOVO PHARMACEUTICAL CO., LTD. Ningbo CN	100030313;100047776	CEP 2023-095 - Rev 02	2026/04/17	Valid	05/06/2028	Chemical	2026/04/17	Notification\|CEP granted\|17/04/2026; Minor revision\|Accepted - CEP remains valid\|25/06/2024; Minor revision\|CEP granted\|17/11/2023; New application\|CEP granted\|05/06/2023
2330	Leflunomide	BO-CHEM PRIVATE LIMITED Mumbai IN	100050126;100087586	CEP 2025-062 - Rev 00	2026/04/17	Valid	17/04/2031	Chemical	2026/04/17	New application\|CEP granted\|17/04/2026
2335	Ropivacaine hydrochloride monohydrate	NAVINTA LLC Ewing US	100045629;100075187	CEP 2025-463 - Rev 00	2026/04/17	Valid	17/04/2031	Chemical	2026/04/17	New application\|CEP granted\|17/04/2026
3135	Rosuvastatin zinc tetrahydrate, Process 2, form I, milled	EGIS PHARMACEUTICALS PLC. Budapest X HU	100001091;100001662	CEP 2025-506 - Rev 00	2026/04/17	Valid	17/04/2031	Chemical	2026/04/17	New application\|CEP granted\|17/04/2026
2338	Mirtazapine	MEGAFINE PHARMA PRIVATE LIMITED Mumbai IN	100011550;100021133	CEP 2024-116 - Rev 01	2026/04/17	Valid	31/07/2030	Chemical	2026/04/17	Notification\|CEP granted\|17/04/2026; New application\|CEP granted\|31/07/2025
463	Amantadine hydrochloride, Crystalline	ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN	100006039;100002980	CEP 2025-168 - Rev 00	2026/04/17	Valid	17/04/2031	Chemical	2026/04/17	New application\|CEP granted\|17/04/2026
2932	Rivaroxaban, Form-I	CADILA PHARMACEUTICALS LIMITED Ankleshwar IN	100003616;100000498	CEP 2025-140 - Rev 00	2026/04/17	Valid	17/04/2031	Chemical	2026/04/17	New application\|CEP granted\|17/04/2026
549	Dexamethasone sodium phosphate	TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. Tianjin CN	100011805;100018616	CEP 2013-142 - Rev 01	2026/04/16	Valid		Chemical	2026/04/16	Minor revision\|CEP granted\|16/04/2026
627	Nifedipine	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 1999-150 - Rev 07	2026/04/16	Valid		Chemical	2026/04/16	Monograph revision\|CEP granted\|16/04/2026; Notification\|CEP granted\|04/07/2025; Notification\|CEP granted\|05/01/2022; Minor revision\|CEP granted\|17/06/2021
2196	Bicalutamide	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2012-303 - Rev 02	2026/04/16	Valid		Chemical	2026/04/16	Minor revision\|CEP granted\|16/04/2026; Notification\|CEP granted\|23/11/2021
272	Doxycycline hyclate	HOVIONE PHARMASCIENCE LIMITED Taipa MO	100013020;100021389	CEP 1996-066 - Rev 08	2026/04/16	Valid		Chemical	2026/04/16	Minor revision\|CEP granted\|16/04/2026; Minor revision\|CEP granted\|18/07/2024; Notification\|Accepted - CEP remains valid\|14/12/2022; Major revision\|CEP granted\|04/11/2020
378	Cetrimide	DISHMAN CARBOGEN AMCIS LIMITED Ahmedabad IN	100012005;100062133	CEP 2007-199 - Rev 04	2026/04/16	Valid		Chemical	2026/04/16	Minor revision\|CEP granted\|16/04/2026; Notification\|CEP granted\|15/07/2024; Minor revision\|Accepted - CEP remains valid\|22/05/2023; Minor revision\|CEP granted\|22/06/2022
1794	Paclitaxel, Produced by fermentation	SAMYANG BIOPHARM CORP. Seongnam-Si KR	100056631;100101588	CEP 2009-255 - Rev 03	2026/04/16	Valid		Chemical	2026/04/16	Transfer of holdership\|CEP granted\|16/04/2026; Minor revision\|CEP granted\|12/08/2021; Minor revision\|CEP granted\|25/09/2020
654	Beclometasone dipropionate	INDUSTRIALE CHIMICA S.R.L. Saronno IT	100011692;100020331	CEP 2019-108 - Rev 01	2026/04/16	Valid		Chemical	2026/04/16	Renewal\|CEP granted\|16/04/2026
2778	Sitagliptin phosphate monohydrate	UNION QUIMICO FARMACEUTICA, S.A Barcelona ES	100000721;100001301	CEP 2017-252 - Rev 01	2026/04/16	Valid		Chemical	2026/04/16	Renewal\|CEP granted\|16/04/2026
2631	Rosuvastatin calcium	NINGBO MENOVO PHARMACEUTICAL CO., LTD. Ningbo CN	100030313;100047776	CEP 2019-012 - Rev 05	2026/04/16	Valid		Chemical	2026/04/16	Notification\|CEP granted\|16/04/2026; Renewal\|CEP granted\|25/10/2024; Minor revision\|Accepted - CEP remains valid\|15/11/2023; Minor revision\|Accepted - CEP remains valid\|13/05/2022; Minor revision\|CEP granted\|26/03/2021; Administrative procedure\|CEP granted\|24/07/2020; Monograph revision\|CEP granted\|19/06/2020

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)	-