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
2583	Montelukast sodium, Amorphous, non-micronised and micronised	MSN PHARMACHEM PRIVATE LIMITED Sangareddy District IN	100014794;100023345	CEP 2012-091 - Rev 01	2025/02/17	Valid		Chemical	2025/02/17	Monograph revision\|CEP granted\|17/02/2025
883	Calcitriol	CERBIOS-PHARMA SA Barbengo CH	100015546;100024284	CEP 2012-356 - Rev 01	2025/02/17	Valid		Chemical and TSE	2025/02/17	Monograph revision\|CEP granted\|17/02/2025; Minor revision\|Accepted - CEP remains valid\|23/08/2022; Notification\|Accepted - CEP remains valid\|20/09/2021
1563	Simvastatin	SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN	100008538;100018201	CEP 2001-384 - Rev 09	2025/02/17	Valid		Chemical	2025/02/17	Minor revision\|CEP granted\|17/02/2025; Notification\|Rejected\|14/01/2025
2856	Pirfenidone	ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN	100006039;100002980	CEP 2018-147 - Rev 02	2025/02/17	Valid		Chemical	2025/10/14	Minor revision\|Accepted - CEP remains valid\|14/10/2025; Renewal\|CEP granted\|17/02/2025; Minor revision\|CEP granted\|01/02/2023; Minor revision\|Accepted - CEP remains valid\|04/02/2021
1455	Ofloxacin	SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN	100008538;100018201	CEP 2000-106 - Rev 10	2025/02/17	Valid		Chemical	2025/02/17	Minor revision\|CEP granted\|17/02/2025; Minor revision\|CEP granted\|28/02/2024; Minor revision\|Accepted - CEP remains valid\|17/03/2022; Notification\|CEP granted\|29/07/2021; Minor revision\|CEP granted\|01/12/2020
2288	Citalopram hydrobromide	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2009-248 - Rev 05	2025/02/17	Valid		Chemical	2025/02/17	Notification\|CEP granted\|17/02/2025; Minor revision\|CEP granted\|17/06/2024; Minor revision\|Accepted - CEP remains valid\|04/09/2023; Minor revision\|CEP granted\|14/10/2021; Notification\|Rejected\|06/08/2021
2641	Dutasteride	SHAKTI LIFESCIENCE PRIVATE LIMITED Mumbai IN	100048889;100089578	CEP 2022-172 - Rev 00	2025/02/17	Valid	17/02/2030	Chemical	2025/02/17	New application\|CEP granted\|17/02/2025
2254	Moxifloxacin hydrochloride	CHONGQING HUAPONT PHARMACEUTICAL CO., LTD. Chongqing CN	100038938;100061197	CEP 2021-458 - Rev 00	2025/02/17	Valid	17/02/2030	Chemical	2025/02/17	New application\|CEP granted\|17/02/2025
1575	Tiapride hydrochloride, Process 2	OLON S.P.A. Rodano IT	100012085;100019537	CEP 2014-274 - Rev 01	2025/02/13	Valid		Chemical	2025/02/13	Notification\|CEP granted\|13/02/2025; Minor revision\|Accepted - CEP remains valid\|28/05/2024; Minor revision\|Accepted - CEP remains valid\|13/02/2023
1354	Oxybutynin hydrochloride	OLON S.P.A. Rodano IT	100012085;100019537	CEP 2019-350 - Rev 01	2025/02/13	Valid	08/11/2027	Chemical	2025/02/13	Notification\|CEP granted\|13/02/2025
2531	Clopidogrel hydrogen sulfate, Form-II, milled and non-milled	MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN	100018316;100070723	CEP 2019-318 - Rev 01	2025/02/13	Valid		Chemical	2025/02/13	Renewal\|CEP granted\|13/02/2025
23	Diphenhydramine hydrochloride	SUPRIYA LIFESCIENCE LIMITED Mumbai IN	100015796;100024574	CEP 2019-120 - Rev 01	2025/02/13	Valid	27/09/2027	Chemical	2025/02/13	Minor revision\|CEP granted\|13/02/2025
2736	Imatinib mesilate	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2015-096 - Rev 05	2025/02/13	Valid		Chemical	2025/02/13	Administrative procedure\|CEP granted\|13/02/2025; Minor revision\|CEP granted\|03/01/2025; Notification\|CEP granted\|19/07/2023; Notification\|Accepted - CEP remains valid\|22/11/2022; Administrative procedure\|CEP granted\|02/12/2021; Notification\|CEP granted\|22/11/2021; Minor revision\|Accepted - CEP remains valid\|17/09/2021; Renewal\|CEP granted\|24/06/2021; Minor revision\|Accepted - CEP remains valid\|30/06/2020
1272	Tryptophan	Ajinomoto Co., Inc. Tokyo JP	100011941;100021464	CEP 1998-137 - Rev 07	2025/02/12	Valid		Chemical	2025/02/13	Notification\|CEP granted\|13/02/2025; Notification\|CEP granted\|12/02/2024; Notification\|CEP granted\|31/03/2023
1137	Pentamidine diisetionate	EMCURE PHARMACEUTICALS LIMITED Pune IN	100011677;100022690	CEP 2022-169 - Rev 01	2025/02/12	Valid	10/03/2028	Chemical	2025/02/12	Notification\|CEP granted\|12/02/2025; New application\|CEP granted\|10/03/2023
2631	Rosuvastatin calcium, AM code	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2024-400 - Rev 01	2025/02/12	Valid	14/01/2030	Chemical	2025/02/12	Administrative procedure\|CEP granted\|12/02/2025; New application\|CEP granted\|14/01/2025
1711	Buspirone hydrochloride	MAITHRI LABORATORIES PRIVATE LIMITED Gaddapotharam Village IN	100013041;100021615	CEP 2023-395 - Rev 00	2025/02/12	Valid	12/02/2030	Chemical	2025/09/09	Minor revision\|Accepted - CEP remains valid\|09/09/2025; New application\|CEP granted\|12/02/2025
1045	Sulpiride	OLON S.P.A. Rodano IT	100012085;100019537	CEP 1998-073 - Rev 10	2025/02/12	Valid		Chemical	2025/02/12	Notification\|CEP granted\|12/02/2025; Minor revision\|Accepted - CEP remains valid\|28/06/2024; Minor revision\|Accepted - CEP remains valid\|26/08/2022; Minor revision\|CEP granted\|27/04/2021
1564	Sodium alendronate trihydrate	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2007-048 - Rev 03	2025/02/12	Valid		Chemical	2025/02/12	Minor revision\|CEP granted\|12/02/2025; Notification\|CEP granted\|11/01/2024; Minor revision\|Accepted - CEP remains valid\|31/07/2023; Minor revision\|Accepted - CEP remains valid\|25/05/2022
330	Gelatin, Acid bone gelatin	TESSENDERLO GROUP N.V. Vilvoorde BE	100038809;100060926	CEP 2008-187 - Rev 01	2025/02/12	Valid		TSE	2025/02/12	Major revision\|CEP granted\|12/02/2025

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)	-