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
1075	Budesonide, Micronised	Hubei Gedian Humanwell Pharmaceutical Co., Ltd. Ezhou City CN	100015482;100024200	CEP 2019-295 - Rev 02	2024/12/17	Valid	17/07/2025	Chemical	2024/12/17	Minor revision\|CEP granted\|17/12/2024; Minor revision\|CEP granted\|13/05/2024
354	Prednisone	SHANDONG XINHUA PHARMACEUTICAL CO., LTD. Zibo CN	100011788;100019607	CEP 2022-349 - Rev 00	2024/12/17	Valid	17/12/2029	Chemical	2024/12/17	New application\|CEP granted\|17/12/2024
1773	Cabergoline	TAPI CZECH INDUSTRIES S.R.O. Opava CZ	100051642;100090678	CEP 2006-170 - Rev 05	2024/12/17	Valid		Chemical	2024/12/17	Notification\|CEP granted\|17/12/2024; Notification\|CEP granted\|26/08/2024; Minor revision\|Accepted - CEP remains valid\|06/01/2023; Notification\|CEP granted\|04/02/2021
2136	Ritonavir	ANHUI BIOCHEM PHARMACEUTICAL CO., LTD. Fuyang CN	100047841;100079107	CEP 2022-394 - Rev 00	2024/12/17	Valid	17/12/2029	Chemical	2024/12/17	New application\|CEP granted\|17/12/2024
1648	Thioctic acid	SHANDONG LUNING PHARMACEUTICAL CO., LTD. Dongying City CN	100048130;100079629	CEP 2023-328 - Rev 01	2024/12/17	Valid	11/12/2029	Chemical	2024/12/17	Administrative procedure\|CEP granted\|17/12/2024; New application\|CEP granted\|11/12/2024
394	Hydrochlorothiazide, Regular and micronised grade	LAURUS LABS LIMITED Hyderabad IN	100011702;100032608	CEP 2023-218 - Rev 00	2024/12/17	Valid	17/12/2029	Chemical	2024/12/17	New application\|CEP granted\|17/12/2024
260	Amoxicillin trihydrate, Powder, direct compression, compacted and microfine	SANDOZ GMBH Kundl AT	100000546;100000450	CEP 2023-277 - Rev 01	2024/12/17	Valid	18/09/2028	Chemical	2024/12/17	Minor revision\|CEP granted\|17/12/2024; Minor revision\|Accepted - CEP remains valid\|02/07/2024; Notification\|Accepted - CEP remains valid\|02/04/2024; New application\|CEP granted\|18/09/2023
2930	Valganciclovir hydrochloride	AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN	100046306;100076393	CEP 2023-375 - Rev 00	2024/12/17	Valid	17/12/2029	Chemical	2024/12/17	New application\|CEP granted\|17/12/2024
1275	Ursodeoxycholic acid, Process IV	DAEWOONG BIO INC. Hwaseong-Si KR	100024491;100033680	CEP 2022-479 - Rev 01	2024/12/17	Valid	31/03/2028	Chemical	2024/12/17	Major revision\|CEP granted\|17/12/2024; New application\|CEP granted\|31/03/2023
2779	Solifenacin succinate, Process-II	AMOLI ORGANICS PRIVATE LIMITED Mumbai IN	100016500;100025303	CEP 2024-431 - Rev 00	2024/12/17	Valid	17/12/2029	Chemical	2024/12/17	New application\|CEP granted\|17/12/2024
3151	Cannabidiol	INDENA S.P.A. Milano IT	100006081;100011479	CEP 2024-055 - Rev 00	2024/12/17	Valid	17/12/2029	Chemical	2024/12/17	New application\|CEP granted\|17/12/2024
2732	Dienogest, Micronised	QINHUANGDAO ZIZHU PHARMACEUTICAL CO., LTD. Qinhuangdao City CN	100016470;100025257	CEP 2023-376 - Rev 00	2024/12/17	Valid	17/12/2029	Chemical	2024/12/17	New application\|CEP granted\|17/12/2024
786	Riboflavin sodium phosphate hydrate	DSM Nutritional Products AG Kaiseraugst CH	100012007;100022521	CEP 2023-436 - Rev 00	2024/12/17	Valid	17/12/2029	Chemical	2024/12/17	New application\|CEP granted\|17/12/2024
2465	Irbesartan	TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL	100000702;100060842	CEP 2011-251 - Rev 06	2024/12/16	Valid		Chemical	2024/12/16	Major revision\|CEP granted\|16/12/2024; Notification\|CEP granted\|17/06/2024; Minor revision\|Accepted - CEP remains valid\|17/02/2023; Minor revision\|CEP granted\|30/09/2021; Notification\|CEP granted\|03/03/2021; Major revision\|CEP granted\|30/07/2020
2583	Montelukast sodium, Milled and micronised	MOREPEN LABORATORIES LIMITED Baddi IN	100017843;100026642	CEP 2012-003 - Rev 02	2024/12/16	Valid		Chemical	2024/12/16	Monograph revision\|CEP granted\|16/12/2024; Minor revision\|Accepted - CEP remains valid\|17/02/2023; Notification\|CEP granted\|19/08/2022; Minor revision\|Accepted - CEP remains valid\|19/01/2022; Minor revision\|Accepted - CEP remains valid\|19/03/2021
2641	Dutasteride, Crystalline Form-I, Micronised and Non-micronised	MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN	100011732;100018657	CEP 2014-019 - Rev 01	2024/12/16	Valid		Chemical	2024/12/16	Minor revision\|CEP granted\|16/12/2024; Renewal\|CEP granted\|31/08/2020
2778	Sitagliptin phosphate monohydrate	HONOUR LAB LIMITED Hyderabad IN	100011891;100022136	CEP 2016-324 - Rev 01	2024/12/16	Valid		Chemical	2024/12/16	Renewal\|CEP granted\|16/12/2024; Minor revision\|Rejected\|28/02/2024
1648	Thioctic acid	OLON S.P.A. Rodano IT	100012085;100019537	CEP 2009-004 - Rev 06	2024/12/16	Valid		Chemical	2024/12/16	Minor revision\|CEP granted\|16/12/2024; Minor revision\|CEP granted\|05/06/2024; Minor revision\|CEP granted\|20/07/2021
1750	Fluticasone propionate, Micronised	GlaxoSmithKline Research & Development Limited London GB	100005535;100093170	CEP 2018-229 - Rev 02	2024/12/16	Valid		Chemical	2024/12/16	Renewal\|CEP granted\|16/12/2024; Monograph revision\|Accepted - CEP remains valid\|12/07/2021; Notification\|CEP granted\|07/12/2020
2777	Pregabalin	ALMELO PRIVATE LIMITED Shabashpally Village IN	100039135;100061583	CEP 2019-046 - Rev 04	2024/12/16	Valid		Chemical	2024/12/16	Renewal\|CEP granted\|16/12/2024; Minor revision\|CEP granted\|25/10/2023; Transfer of holdership\|CEP granted\|10/03/2022; Minor revision\|Accepted - CEP remains valid\|21/10/2020; Notification\|CEP granted\|16/07/2020

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)	-