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
758	Colchicine	ALCHEM INTERNATIONAL PRIVATE LIMITED Faridabad IN	100011947;100018683	CEP 2019-146 - Rev 02	2025/05/21	Valid		Chemical	2025/05/21	Renewal\|CEP granted\|21/05/2025; Monograph revision\|Accepted - CEP remains valid\|04/11/2024; Minor revision\|CEP granted\|16/02/2024
2931	Sorafenib tosilate	CHONGQING CARELIFE PHARMACEUTICAL CO., LTD. Chongqing CN	100011995;100018631	CEP 2023-373 - Rev 00	2025/05/21	Valid	21/05/2030	Chemical	2025/05/21	New application\|CEP granted\|21/05/2025
2733	Escitalopram oxalate	MICRO LABS LIMITED Bengaluru IN	100017819;100077269	CEP 2016-250 - Rev 02	2025/05/20	Valid		Chemical	2025/05/20	Administrative procedure\|CEP granted\|20/05/2025; Minor revision\|CEP granted\|13/05/2025; Renewal\|CEP granted\|16/01/2023; Minor revision\|CEP granted\|29/04/2022; Minor revision\|Accepted - CEP remains valid\|09/06/2021; Minor revision\|CEP granted\|16/09/2020; Minor revision\|Accepted - CEP remains valid\|05/06/2020
411	Sodium acetate trihydrate	MACCO ORGANIQUES INC Salaberry-de-Valleyfield CA	100033181;100051773	CEP 2018-230 - Rev 01	2025/05/20	Valid		Chemical	2025/05/20	Renewal\|CEP granted\|20/05/2025
2856	Pirfenidone	ROLABO OUTSOURCING, S.L. Zaragoza ES	100012139;100019601	CEP 2018-260 - Rev 01	2025/05/20	Valid		Chemical	2025/05/20	Renewal\|CEP granted\|20/05/2025
2760	Brimonidine tartrate	Farmak A.S. Olomouc CZ	100012043;100022687	CEP 2014-331 - Rev 04	2025/05/19	Valid		Chemical	2025/05/19	Minor revision\|CEP granted\|19/05/2025; Notification\|CEP granted\|06/03/2024; Minor revision\|CEP granted\|20/02/2024; Minor revision\|CEP granted\|27/07/2022; Notification\|Accepted - CEP remains valid\|21/02/2022; Renewal\|CEP granted\|05/07/2021
2815	Entecavir monohydrate	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2017-271 - Rev 05	2025/05/19	Valid		Chemical	2025/05/19	Notification\|CEP granted\|19/05/2025; Renewal\|CEP granted\|10/06/2024; Minor revision\|CEP granted\|28/07/2023; Minor revision\|CEP granted\|22/09/2020
2856	Pirfenidone	OPTIMUS DRUGS PRIVATE LIMITED Hyderabad IN	100020646;100092226	CEP 2018-007 - Rev 02	2025/05/19	Valid		Chemical	2025/05/19	Renewal\|CEP granted\|19/05/2025; Minor revision\|CEP granted\|30/03/2022
2856	Pirfenidone	LAURUS LABS LIMITED Hyderabad IN	100011702;100032608	CEP 2019-062 - Rev 02	2025/05/19	Valid		Chemical	2025/05/19	Renewal\|CEP granted\|19/05/2025; Minor revision\|CEP granted\|11/04/2023; Notification\|Accepted - CEP remains valid\|13/12/2021
2778	Sitagliptin phosphate monohydrate	LAURUS LABS LIMITED Hyderabad IN	100011702;100032608	CEP 2020-215 - Rev 02	2025/05/19	Valid	07/12/2027	Chemical	2025/05/19	Minor revision\|CEP granted\|19/05/2025; Administrative procedure\|CEP granted\|10/03/2023; New application\|CEP granted\|07/12/2022
260	Amoxicillin trihydrate, Powder, Powder extra dry, Compacted grade A, Compacted grade for direct compression, Compacted extra dry	FERSINSA GB S.A. DE C.V. Ramos Arizpe MX	100017238;100052582	CEP 2018-178 - Rev 02	2025/05/19	Valid		Chemical	2025/05/19	Renewal\|CEP granted\|19/05/2025; Minor revision\|Accepted - CEP remains valid\|10/06/2024; Minor revision\|Accepted - CEP remains valid\|23/01/2024; Minor revision\|Accepted - CEP remains valid\|20/11/2023; Minor revision\|Accepted - CEP remains valid\|15/02/2022; Administrative procedure\|CEP granted\|19/08/2020
1168	Piperacillin sodium, Sterile	SHANDONG ANXIN PHARMACEUTICAL CO., LTD Jinan CN	100012114;100052387	CEP 2024-333 - Rev 00	2025/05/19	Valid	19/05/2030	Chemical	2025/11/27	Notification\|Accepted - CEP remains valid\|27/11/2025; New application\|CEP granted\|19/05/2025
2591	Celecoxib, Process-V	MICRO LABS LIMITED Bengaluru IN	100017819;100077269	CEP 2022-345 - Rev 01	2025/05/16	Valid	21/10/2027	Chemical	2025/05/16	Minor revision\|CEP granted\|16/05/2025; New application\|CEP granted\|21/10/2022
1649	Azithromycin, Monohydrate	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2010-131 - Rev 03	2025/05/16	Valid		Chemical	2025/05/16	Notification\|CEP granted\|16/05/2025; Minor revision\|Accepted - CEP remains valid\|24/10/2024; Notification\|Accepted - CEP remains valid\|14/10/2022; Monograph revision\|Accepted - CEP remains valid\|13/05/2022; Minor revision\|CEP granted\|27/10/2021; Notification\|Accepted - CEP remains valid\|19/10/2020
808	Bacampicillin Hydrochloride	FRESENIUS KABI IPSUM S.R.L. Cassina de’ Pecchi IT	100015105;100057989	CEP 2004-188 - Rev 07	2025/05/16	Valid		Chemical	2025/05/16	Minor revision\|CEP granted\|16/05/2025; Minor revision\|Accepted - CEP remains valid\|08/07/2024; Minor revision\|CEP granted\|10/10/2022; Notification\|CEP granted\|02/02/2021; Minor revision\|CEP granted\|07/07/2020
2931	Sorafenib tosilate, Micronised, polymorphic form I	SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou City CN	100014777;100050265	CEP 2023-250 - Rev 02	2025/05/16	Valid	14/12/2028	Chemical	2025/05/16	Monograph revision\|CEP granted\|16/05/2025; Administrative procedure\|CEP granted\|20/12/2023; New application\|CEP granted\|14/12/2023
2617	Aripiprazole, Type-I	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2013-361 - Rev 02	2025/05/16	Valid		Chemical	2025/05/16	Minor revision\|CEP granted\|16/05/2025; Minor revision\|CEP granted\|02/06/2022; Renewal\|CEP granted\|23/09/2021
916	Hydroxyzine hydrochloride	MAHI DRUGS PRIVATE LIMITED Hyderabad IN	100048039;100079525	CEP 2024-075 - Rev 00	2025/05/16	Valid	16/05/2030	Chemical	2025/05/16	New application\|CEP granted\|16/05/2025
2465	Irbesartan, Process II	ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN	100012174;100018701	CEP 2025-025 - Rev 00	2025/05/16	Valid	16/05/2030	Chemical	2025/05/16	New application\|CEP granted\|16/05/2025
2600	Olmesartan medoxomil, Process-II, ZH-LH	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2025-164 - Rev 00	2025/05/16	Valid	16/05/2030	Chemical	2025/05/16	New application\|CEP granted\|16/05/2025

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)	-