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
464	Amitriptyline hydrochloride	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2001-432 - Rev 06	2025/03/11	Valid		Chemical	2025/03/11	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
994	Ciclosporin	TAPI CZECH INDUSTRIES S.R.O. Opava CZ	100051642;100090678	CEP 2002-152 - Rev 07	2025/03/11	Valid		Chemical	2025/03/11	Notification\|CEP granted\|11/03/2025; Minor revision\|CEP granted\|21/06/2023; Monograph revision\|CEP granted\|02/09/2021; Minor revision\|Accepted - CEP remains valid\|24/02/2020
2423	Valsartan	MACLEODS PHARMACEUTICALS LIMITED Mumbai IN	100021441;100077265	CEP 2011-180 - Rev 08	2025/03/11	Valid		Chemical	2025/03/11	Notification\|CEP granted\|11/03/2025; Minor revision\|CEP granted\|01/08/2024; Major revision\|CEP granted\|19/04/2024; Minor revision\|Accepted - CEP remains valid\|23/05/2023; Minor revision\|Accepted - CEP remains valid\|30/08/2022; Major revision\|CEP granted\|25/02/2022; Minor revision\|Rejected\|09/08/2021
299	Theophylline	SHANDONG XINHUA PHARMACEUTICAL CO., LTD. Zibo CN	100011788;100019607	CEP 1998-004 - Rev 08	2025/03/11	Valid		Chemical	2025/03/11	Minor revision\|CEP granted\|11/03/2025
1140	Potassium clavulanate	SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. Linyi CN	100025540;100034769	CEP 2011-374 - Rev 01	2025/03/11	Valid		Chemical	2025/03/11	Notification\|CEP granted\|11/03/2025; Minor revision\|Accepted - CEP remains valid\|29/02/2024; Minor revision\|Accepted - CEP remains valid\|03/10/2022; Minor revision\|Accepted - CEP remains valid\|13/02/2020
2777	Pregabalin	DONG BANG FUTURE TECH & LIFE CO., LTD. Hwaseong-si KR	100024414;100042624	CEP 2018-148 - Rev 01	2025/03/11	Valid		Chemical	2025/03/11	Renewal\|CEP granted\|11/03/2025
2531	Clopidogrel hydrogen sulfate, Form II	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2017-260 - Rev 01	2025/03/11	Valid		Chemical	2025/03/11	Notification\|CEP granted\|11/03/2025; Renewal\|CEP granted\|30/03/2023; Minor revision\|CEP granted\|27/07/2022; Notification\|CEP granted\|24/02/2022; Minor revision\|CEP granted\|26/03/2020
14	Calcium carbonate	SUDEEP PHARMA LIMITED Vadodara IN	100033274;100051937	CEP 2013-299 - Rev 03	2025/03/11	Valid		Chemical	2025/03/11	Notification\|CEP granted\|11/03/2025; Minor revision\|CEP granted\|31/08/2022
1653	Potassium clavulanate, diluted, With microcrystalline cellulose in the ratio 1:1	SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. Linyi CN	100025540;100034769	CEP 2011-375 - Rev 03	2025/03/11	Valid		Chemical	2025/03/11	Notification\|CEP granted\|11/03/2025; Minor revision\|Accepted - CEP remains valid\|29/02/2024; Minor revision\|Accepted - CEP remains valid\|04/10/2022; Minor revision\|CEP granted\|08/04/2021; Minor revision\|Accepted - CEP remains valid\|20/02/2020
2244	Tacrolimus monohydrate	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2018-233 - Rev 06	2025/03/11	Valid		Chemical	2025/03/11	Administrative procedure\|CEP granted\|11/03/2025; Notification\|CEP granted\|04/03/2025; Renewal\|CEP granted\|05/08/2024; Minor revision\|Accepted - CEP remains valid\|17/11/2023; Minor revision\|CEP granted\|25/11/2022; Major revision\|CEP granted\|06/04/2022; Minor revision\|Rejected\|04/11/2021; Minor revision\|CEP granted\|01/09/2020
14	Calcium carbonate, Granular	SUDEEP PHARMA LIMITED Vadodara IN	100033274;100051937	CEP 2020-379 - Rev 02	2025/03/11	Valid	21/04/2026	Chemical	2025/03/11	Notification\|CEP granted\|11/03/2025; Minor revision\|CEP granted\|02/09/2022; New application\|CEP granted\|21/04/2021
3036	Teriflunomide	ALIVUS LIFE SCIENCES LIMITED Mumbai IN	100023468;100069944	CEP 2023-135 - Rev 01	2025/03/11	Valid	25/07/2029	Chemical	2025/03/11	Minor revision\|CEP granted\|11/03/2025; New application\|CEP granted\|26/07/2024
2335	Ropivacaine hydrochloride monohydrate	EDMOND PHARMA S.R.L. Paderno Dugnano IT	100000246;100002746	CEP 2007-342 - Rev 04	2025/03/11	Valid		Chemical	2025/03/11	Notification\|CEP granted\|11/03/2025; Minor revision\|Accepted - CEP remains valid\|31/07/2023; Notification\|Rejected\|15/05/2023; Minor revision\|CEP granted\|15/07/2021
1673	Isoflurane	SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. Linyi CN	100025540;100034769	CEP 2010-078 - Rev 01	2025/03/11	Valid		Chemical	2025/03/24	Minor revision\|Accepted - CEP remains valid\|24/03/2025; Notification\|CEP granted\|11/03/2025; Minor revision\|Accepted - CEP remains valid\|04/09/2020
1275	Ursodeoxycholic acid	ARCH PHARMALABS LIMITED Mumbai IN	100011823;100095249	CEP 2019-029 - Rev 06	2025/03/11	Valid		Chemical and TSE	2025/10/15	Renewal\|Accepted - CEP remains valid\|15/10/2025; Notification\|CEP granted\|11/03/2025; Minor revision\|CEP granted\|17/06/2024; Minor revision\|CEP granted\|07/02/2024; Notification\|CEP granted\|04/12/2023; Minor revision\|CEP granted\|23/08/2023; Minor revision\|CEP granted\|19/12/2022
1373	Testosterone	SHAKTI LIFESCIENCE PRIVATE LIMITED Mumbai IN	100048889;100089578	CEP 2023-267 - Rev 00	2025/03/11	Valid	11/03/2030	Chemical	2025/03/11	New application\|CEP granted\|11/03/2025
673	Medroxyprogesterone acetate, Crystalline	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 1999-153 - Rev 05	2025/03/10	Valid		Chemical	2025/03/10	Notification\|CEP granted\|10/03/2025; Notification\|CEP granted\|23/11/2021; Minor revision\|CEP granted\|11/03/2021; Notification\|CEP granted\|07/08/2020
611	Fluorouracil	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2005-113 - Rev 06	2025/03/10	Valid		Chemical	2025/03/10	Notification\|CEP granted\|10/03/2025; Minor revision\|Accepted - CEP remains valid\|04/03/2024; Minor revision\|Abandoned\|13/09/2023; Notification\|CEP granted\|22/11/2021; Minor revision\|CEP granted\|13/04/2021
673	Medroxyprogesterone acetate, Micronised (M1, M2, M3)	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2000-276 - Rev 06	2025/03/10	Valid		Chemical	2025/03/10	Notification\|CEP granted\|10/03/2025; Notification\|CEP granted\|23/11/2021; Minor revision\|CEP granted\|13/04/2021
599	Cisplatin	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2000-411 - Rev 04	2025/03/10	Valid		Chemical	2025/03/10	Notification\|CEP granted\|10/03/2025; Monograph revision\|CEP granted\|18/10/2022

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)	-