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
919	Ipratropium bromide	SCL LIFESCIENCES LIMITED Sahibzada Ajit Singh Nagar IN	100011774;100018647	CEP 2022-470 - Rev 02	2025/09/09	Valid	12/02/2029	Chemical	2025/09/09	Minor revision\|CEP granted\|09/09/2025; Notification\|CEP granted\|17/03/2025; New application\|CEP granted\|12/02/2024
1752	Ganciclovir	SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO., LTD. Luoyang Town CN	100020594;100034407	CEP 2024-086 - Rev 00	2025/09/09	Valid	09/09/2030	Chemical	2025/09/09	New application\|CEP granted\|09/09/2025
1084	Cetirizine dihydrochloride, Process B	WAVELENGTH ENTERPRISES LTD. Petah Tikva IL	100018877;100092992	CEP 2021-309 - Rev 03	2025/09/09	Valid	24/11/2026	Chemical	2025/11/06	Minor revision\|Accepted - CEP remains valid\|06/11/2025; Notification\|CEP granted\|09/09/2025; Notification\|CEP granted\|23/10/2024; Minor revision\|CEP granted\|22/05/2024; Minor revision\|Accepted - CEP remains valid\|25/07/2022; New application\|CEP granted\|24/11/2021
542	Busulfan	FRESENIUS KABI ONCOLOGY LIMITED Kalyani IN	100011513;100018607	CEP 2010-374 - Rev 09	2025/09/08	Valid		Chemical	2025/09/08	Minor revision\|CEP granted\|08/09/2025; Minor revision\|CEP granted\|03/02/2025; Minor revision\|Accepted - CEP remains valid\|22/08/2024; Notification\|CEP granted\|13/10/2023; Notification\|CEP granted\|13/01/2023; Notification\|Accepted - CEP remains valid\|14/04/2022; Minor revision\|CEP granted\|18/03/2022; Notification\|CEP granted\|14/09/2020
2422	Oseltamivir phosphate	ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN	100011833;100018698	CEP 2023-196 - Rev 01	2025/09/08	Valid	25/09/2029	Chemical	2025/09/08	Minor revision\|CEP granted\|08/09/2025; Minor revision\|Accepted - CEP remains valid\|10/03/2025; New application\|CEP granted\|25/09/2024
1269	Sufentanil citrate	HAMELN RDS S.R.O. Modra SK	100000646;100003437	CEP 2022-096 - Rev 04	2025/09/08	Valid	17/08/2028	Chemical	2025/09/08	Minor revision\|CEP granted\|08/09/2025; Minor revision\|CEP granted\|22/08/2024; Minor revision\|CEP granted\|30/01/2024; Administrative procedure\|CEP granted\|31/08/2023; New application\|CEP granted\|17/08/2023
1791	Sodium ascorbate	CSPC WEISHENG PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. Shijiazhuang City CN	100024035;100082015	CEP 2012-262 - Rev 04	2025/09/08	Valid		Chemical	2025/11/04	Notification\|Accepted - CEP remains valid\|04/11/2025; Minor revision\|CEP granted\|08/09/2025; Notification\|Accepted - CEP remains valid\|05/03/2025; Notification\|CEP granted\|22/02/2024; Monograph revision\|Accepted - CEP remains valid\|27/07/2023; Notification\|Accepted - CEP remains valid\|11/04/2023; Notification\|Accepted - CEP remains valid\|24/11/2022; Notification\|CEP granted\|21/09/2022; Notification\|Accepted - CEP remains valid\|07/04/2022; Notification\|CEP granted\|07/04/2021
803	Amiodarone hydrochloride	CTX LIFESCIENCES PVT. LIMITED Surat IN	100019102;100027863	CEP 2009-129 - Rev 02	2025/09/05	Valid		Chemical	2025/09/05	Monograph revision\|CEP granted\|05/09/2025; Minor revision\|Accepted - CEP remains valid\|24/08/2023; Minor revision\|CEP granted\|25/03/2021
1649	Azithromycin, Dihydrate	JUBILANT BIOSYS LIMITED Nanjangud IN	100055198;100098088	CEP 2007-119 - Rev 07	2025/09/05	Valid		Chemical	2025/09/05	Notification\|CEP granted\|05/09/2025; Minor revision\|CEP granted\|29/09/2022
2423	Valsartan	JUBILANT BIOSYS LIMITED Nanjangud IN	100055198;100098088	CEP 2011-110 - Rev 10	2025/09/05	Valid		Chemical	2025/09/05	Notification\|CEP granted\|05/09/2025; Minor revision\|CEP granted\|17/07/2024; Notification\|CEP granted\|12/07/2023; Notification\|CEP granted\|24/04/2023; Minor revision\|CEP granted\|26/09/2022; Notification\|CEP granted\|11/08/2022; Minor revision\|Accepted - CEP remains valid\|11/08/2021; Minor revision\|CEP granted\|06/07/2020
803	Amiodarone hydrochloride, Pubagang site	ZHEJIANG HENGKANG PHARMACEUTICAL CO., LTD. Sanmen CN	100034135;100082085	CEP 2021-349 - Rev 01	2025/09/05	Valid	20/12/2026	Chemical	2025/09/05	Minor revision\|CEP granted\|05/09/2025; Monograph revision\|Accepted - CEP remains valid\|10/04/2025; Minor revision\|Accepted - CEP remains valid\|19/11/2024; Minor revision\|Accepted - CEP remains valid\|06/10/2022; New application\|CEP granted\|20/12/2021
1559	Risperidone	JUBILANT BIOSYS LIMITED Nanjangud IN	100055198;100098088	CEP 2002-151 - Rev 08	2025/09/05	Valid		Chemical	2025/09/05	Notification\|CEP granted\|05/09/2025; Notification\|CEP granted\|23/08/2022
2703	Ciclesonide	STERLING S.p.A. Solomeo Di Corciano IT	100024377;100033551	CEP 2018-249 - Rev 01	2025/09/05	Valid		Chemical	2025/09/05	Renewal\|CEP granted\|05/09/2025; Notification\|Accepted - CEP remains valid\|12/03/2021
2775	Nebivolol hydrochloride	MACLEODS PHARMACEUTICALS LIMITED Mumbai IN	100021441;100077265	CEP 2024-172 - Rev 00	2025/09/04	Valid	04/09/2030	Chemical	2025/09/04	New application\|CEP granted\|04/09/2025
2541	Quetiapine Fumarate	JUBILANT BIOSYS LIMITED Nanjangud IN	100055198;100098088	CEP 2014-108 - Rev 03	2025/09/04	Valid		Chemical	2025/09/04	Notification\|CEP granted\|04/09/2025; Minor revision\|CEP granted\|23/02/2024; Notification\|CEP granted\|12/08/2022; Renewal\|CEP granted\|26/10/2021
2757	Aprepitant	JUBILANT BIOSYS LIMITED Nanjangud IN	100055198;100098088	CEP 2017-051 - Rev 02	2025/09/04	Valid		Chemical	2025/09/04	Notification\|CEP granted\|04/09/2025; Notification\|Accepted - CEP remains valid\|17/05/2024; Minor revision\|CEP granted\|06/12/2023; Renewal\|CEP granted\|11/08/2023; Notification\|CEP granted\|11/08/2022; Minor revision\|Accepted - CEP remains valid\|22/06/2021
2918	Everolimus, with 2% BHT	CONCORD BIOTECH LIMITED Ahmedabad IN	100005519;100000897	CEP 2022-106 - Rev 01	2025/09/04	Valid	11/01/2029	Chemical	2025/09/04	Minor revision\|CEP granted\|04/09/2025; New application\|CEP granted\|11/01/2024
2443	Fulvestrant, Process 2	INDUSTRIALE CHIMICA S.R.L. Saronno IT	100011692;100020331	CEP 2025-324 - Rev 00	2025/09/04	Valid	04/09/2030	Chemical	2025/09/04	New application\|CEP granted\|04/09/2025
405	Peppermint oil	DÜLLBERG KONZENTRA GMBH & CO. KG Hamburg DE	100022402;100031085	CEP 2015-136 - Rev 01	2025/09/04	Valid		Herbal	2025/12/02	Minor revision\|Accepted - CEP remains valid\|02/12/2025; Minor revision\|CEP granted\|04/09/2025; Minor revision\|Accepted - CEP remains valid\|26/05/2023; Renewal\|CEP granted\|31/08/2021
2743	Zoledronic acid monohydrate	JUBILANT BIOSYS LIMITED Nanjangud IN	100055198;100098088	CEP 2019-349 - Rev 02	2025/09/04	Valid	24/03/2026	Chemical	2025/09/04	Notification\|CEP granted\|04/09/2025; Notification\|CEP granted\|11/08/2022

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)	-