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
2196	Bicalutamide	MAC-CHEM PRODUCTS (INDIA) PRIVATE LIMITED Mumbai IN	100023737;100061579	CEP 2019-329 - Rev 02	2026/04/21	Valid		Chemical	2026/04/21	Renewal\|CEP granted\|21/04/2026; Administrative procedure\|CEP granted\|30/04/2024
285	Noradrenaline tartrate	EDMOND PHARMA S.R.L. Paderno Dugnano IT	100000246;100002746	CEP 2020-089 - Rev 01	2026/04/21	Valid		Chemical	2026/04/21	Renewal\|CEP granted\|21/04/2026; Minor revision\|Accepted - CEP remains valid\|10/11/2022; New application\|CEP granted\|08/06/2021
851	Pentoxifylline	SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN	100008538;100018201	CEP 1998-139 - Rev 07	2026/04/20	Valid		Chemical	2026/04/20	Minor revision\|CEP granted\|20/04/2026; Notification\|CEP granted\|02/10/2023; Monograph revision\|Accepted - CEP remains valid\|21/07/2020; Minor revision\|Accepted - CEP remains valid\|27/03/2020
2280	Fexofenadine hydrochloride, Non-micronised and micronised	VIRUPAKSHA ORGANICS LIMITED Hyderabad IN	100021606;100076961	CEP 2009-160 - Rev 05	2026/04/20	Valid		Chemical	2026/04/20	Minor revision\|CEP granted\|20/04/2026; Minor revision\|CEP granted\|17/07/2024; Administrative procedure\|CEP granted\|13/04/2023; Minor revision\|Accepted - CEP remains valid\|04/04/2023; Minor revision\|CEP granted\|19/06/2020
353	Prednisolone, Process A, micronised	HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN	100016183;100024971	CEP 2014-153 - Rev 02	2026/04/20	Valid		Chemical	2026/04/20	Minor revision\|CEP granted\|20/04/2026; Minor revision\|Accepted - CEP remains valid\|10/02/2025; Minor revision\|Accepted - CEP remains valid\|09/12/2022
2751	Valaciclovir hydrochloride hydrate	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy IN	100051463;100098142	CEP 2014-086 - Rev 04	2026/04/20	Valid		Chemical	2026/04/20	Minor revision\|CEP granted\|20/04/2026; Notification\|CEP granted\|19/07/2024; Minor revision\|CEP granted\|07/07/2023; Minor revision\|CEP granted\|30/06/2021; Renewal\|CEP granted\|29/04/2020
2334	Letrozole	NOVARTIS PHARMA AG Basel CH	100003908;100000364	CEP 2019-149 - Rev 01	2026/04/20	Valid		Chemical	2026/04/20	Renewal\|CEP granted\|20/04/2026; Monograph revision\|Accepted - CEP remains valid\|07/04/2021
2606	Tadalafil	ANHUI BIOCHEM PHARMACEUTICAL CO., LTD. Fuyang CN	100047841;100079107	CEP 2024-224 - Rev 00	2026/04/20	Valid	20/04/2031	Chemical	2026/04/20	New application\|CEP granted\|20/04/2026
2039	Tolfenamic acid	CHR. OLESEN SYNTHESIS A/S Hvidovre DK	100020576;100029329	CEP 2020-004 - Rev 01	2026/04/20	Valid		Chemical	2026/04/20	Renewal\|CEP granted\|20/04/2026; Major revision\|Accepted - CEP remains valid\|26/08/2024; Minor revision\|Accepted - CEP remains valid\|06/05/2022; New application\|CEP granted\|16/07/2021
2932	Rivaroxaban, Non-micronised, Micronised	ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. Starogard Gdanski PL	100000470;100001572	CEP 2021-270 - Rev 04	2026/04/20	Valid	05/07/2028	Chemical	2026/04/20	Minor revision\|CEP granted\|20/04/2026; Notification\|Rejected\|04/02/2026; Minor revision\|CEP granted\|23/08/2024; Minor revision\|Accepted - CEP remains valid\|05/03/2024; Administrative procedure\|CEP granted\|13/10/2023; Minor revision\|CEP granted\|10/10/2023; New application\|CEP granted\|05/07/2023
599	Cisplatin	FRESENIUS KABI ONCOLOGY LIMITED Kalyani IN	100011513;100018607	CEP 2025-204 - Rev 00	2026/04/20	Valid	20/04/2031	Chemical	2026/04/20	New application\|CEP granted\|20/04/2026
2761	Bupivacaine	MSN LIFE SCIENCES PRIVATE LIMITED Kamareddy IN	100018316;100070723	CEP 2024-506 - Rev 00	2026/04/20	Valid	20/04/2031	Chemical	2026/04/20	New application\|CEP granted\|20/04/2026
856	Prazosin hydrochloride	BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI S.P.A. Novi Ligure IT	100001870;100092872	CEP 2004-221 - Rev 04	2026/04/17	Valid		Chemical	2026/04/17	Major revision\|CEP granted\|17/04/2026; Minor revision\|Accepted - CEP remains valid\|09/12/2021; Minor revision\|CEP granted\|07/06/2021
657	Chlorhexidine diacetate	MEDICHEM, S.A. Sant Joan Despi ES	100001017;100002951	CEP 2018-123 - Rev 03	2026/04/17	Valid		Chemical	2026/04/17	Notification\|CEP granted\|17/04/2026; Renewal\|CEP granted\|19/02/2024; Minor revision\|Accepted - CEP remains valid\|22/08/2022; Minor revision\|CEP granted\|19/04/2022
2570	Desloratadine	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy IN	100051463;100098142	CEP 2013-319 - Rev 03	2026/04/17	Valid		Chemical	2026/04/17	Minor revision\|CEP granted\|17/04/2026; Notification\|CEP granted\|11/07/2024; Minor revision\|CEP granted\|28/05/2021
659	Chlorhexidine dihydrochloride	MEDICHEM, S.A. Sant Joan Despi ES	100001017;100002951	CEP 2018-081 - Rev 03	2026/04/17	Valid		Chemical	2026/04/17	Notification\|CEP granted\|17/04/2026; Renewal\|CEP granted\|19/02/2024; Minor revision\|Accepted - CEP remains valid\|22/08/2022; Minor revision\|CEP granted\|19/04/2022
2288	Citalopram hydrobromide, Micronised and non-micronised	ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN	100011833;100018698	CEP 2010-037 - Rev 02	2026/04/17	Valid		Chemical	2026/04/17	Minor revision\|CEP granted\|17/04/2026; Minor revision\|Accepted - CEP remains valid\|05/05/2023; Notification\|Accepted - CEP remains valid\|03/02/2023; Minor revision\|Accepted - CEP remains valid\|17/03/2022; Minor revision\|Accepted - CEP remains valid\|18/10/2021; Minor revision\|CEP granted\|17/07/2020
1745	Carvedilol	ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. Starogard Gdanski PL	100000470;100001572	CEP 2002-258 - Rev 10	2026/04/17	Valid		Chemical	2026/04/17	Notification\|CEP granted\|17/04/2026; Minor revision\|CEP granted\|02/09/2025; Major revision\|CEP granted\|22/10/2021; Minor revision\|CEP granted\|22/01/2021
2606	Tadalafil	ASSURGEN PHARMA PRIVATE LIMITED Visakhapatnam IN	100048048;100101722	CEP 2021-498 - Rev 01	2026/04/17	Valid	30/08/2028	Chemical	2026/04/17	Notification\|CEP granted\|17/04/2026; New application\|CEP granted\|30/08/2023
2576	Voriconazole, Form-I VZ Process	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2022-325 - Rev 02	2026/04/17	Valid	03/01/2028	Chemical	2026/04/17	Major revision\|CEP granted\|17/04/2026; Minor revision\|Rejected\|01/12/2025; Minor revision\|CEP granted\|15/11/2024; New application\|CEP granted\|03/01/2023

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)	-