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
402	Magnesium chloride hexahydrate	CFL CHEMISCHE FABRIK LEHRTE GMBH & CO. KG Lehrte DE	100021016;100029727	CEP 2017-044 - Rev 01	2025/03/21	Valid		Chemical	2025/03/21	Notification\|CEP granted\|21/03/2025; Notification\|Accepted - CEP remains valid\|22/06/2023; Renewal\|CEP granted\|25/01/2023; Notification\|Accepted - CEP remains valid\|23/08/2021
260	Amoxicillin trihydrate, Compacted	SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD Datong CN	100033465;100052362	CEP 2021-461 - Rev 02	2025/03/21	Valid	18/05/2027	Chemical	2025/09/26	Minor revision\|Accepted - CEP remains valid\|26/09/2025; Minor revision\|CEP granted\|21/03/2025; Minor revision\|CEP granted\|20/12/2023; New application\|CEP granted\|18/05/2022
2768	Fluticasone furoate	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2022-015 - Rev 02	2025/03/21	Valid	03/08/2028	Chemical	2025/03/21	Notification\|CEP granted\|21/03/2025; Minor revision\|CEP granted\|11/03/2024; New application\|CEP granted\|03/08/2023
767	Fludrocortisone acetate	HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN	100016183;100024971	CEP 2021-435 - Rev 01	2025/03/21	Valid	21/05/2029	Chemical	2025/03/21	Monograph revision\|CEP granted\|21/03/2025; New application\|CEP granted\|21/05/2024
1699	Mesalazine	MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN	100018316;100070723	CEP 2024-351 - Rev 00	2025/03/20	Valid	20/03/2030	Chemical	2025/03/20	New application\|CEP granted\|20/03/2025
1912	Fish oil, rich in omega-3-acids, Type I	CHEMPORT INC. Naju-si KR	100023666;100032833	CEP 2015-282 - Rev 01	2025/03/20	Valid		Chemical	2025/03/20	Minor revision\|CEP granted\|20/03/2025; Renewal\|CEP granted\|17/03/2022; Minor revision\|Accepted - CEP remains valid\|02/02/2021
941	Nortriptyline hydrochloride	VASUDHA PHARMA CHEM LIMITED Hyderabad IN	100011811;100018603	CEP 2017-066 - Rev 01	2025/03/20	Valid		Chemical	2025/03/20	Minor revision\|CEP granted\|20/03/2025; Renewal\|CEP granted\|31/07/2023; Notification\|CEP granted\|02/02/2023; Minor revision\|Accepted - CEP remains valid\|06/05/2020
1513	Etofenamate	ESTEVE QUIMICA S.A. Barcelona ES	100002266;100056508	CEP 2012-114 - Rev 03	2025/03/20	Valid		Chemical	2025/03/20	Minor revision\|CEP granted\|20/03/2025; Notification\|Accepted - CEP remains valid\|13/05/2024; Notification\|Accepted - CEP remains valid\|26/01/2023; Notification\|Rejected\|08/12/2022; Transfer of holdership\|CEP granted\|16/03/2022; Administrative procedure\|CEP granted\|23/10/2020
2416	Pramipexole dihydrochloride monohydrate	MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN	100011732;100018657	CEP 2011-050 - Rev 02	2025/03/20	Valid		Chemical	2025/03/20	Minor revision\|CEP granted\|20/03/2025; Notification\|Accepted - CEP remains valid\|28/10/2021; Notification\|Rejected\|10/09/2021; Minor revision\|CEP granted\|18/08/2020
3095	Dabigatran etexilate mesilate, Form I	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2024-114 - Rev 01	2025/03/20	Valid	15/01/2030	Chemical	2025/11/04	Minor revision\|Rejected\|04/11/2025; Notification\|CEP granted\|20/03/2025; New application\|CEP granted\|15/01/2025
1489	Ambroxol hydrochloride	KORES (INDIA) LIMITED Navi Mumbai IN	100020521;100087957	CEP 2022-242 - Rev 00	2025/03/20	Valid	20/03/2030	Chemical	2025/09/05	Minor revision\|Accepted - CEP remains valid\|05/09/2025; Notification\|Rejected\|22/08/2025; New application\|CEP granted\|21/03/2025
687	Salbutamol sulfate	GlaxoSmithKline Research & Development Limited London GB	100005535;100093170	CEP 2023-371 - Rev 00	2025/03/20	Valid	20/03/2030	Chemical	2025/03/20	New application\|CEP granted\|20/03/2025
579	Aprotinin concentrated solution, Activity: 100 - 136 Ph. Eur. Units of aprotinin activity per mL Bacterial endotoxin free	PENTAPHARM AG Aesch CH	100025404;100052203	CEP 2002-095 - Rev 07	2025/03/20	Valid		Chemical and TSE	2025/03/20	Monograph revision\|CEP granted\|20/03/2025; Notification\|Accepted - CEP remains valid\|17/07/2023; Transfer of holdership\|CEP granted\|30/06/2023; Notification\|Accepted - CEP remains valid\|04/04/2022; Monograph revision\|CEP granted\|23/02/2022; Minor revision\|Accepted - CEP remains valid\|27/11/2020
562	Sodium cromoglicate	FERMION OY Espoo FI	100011508;100020280	CEP 2013-136 - Rev 01	2025/03/20	Valid		Chemical	2025/03/20	Minor revision\|CEP granted\|20/03/2025; Minor revision\|Accepted - CEP remains valid\|16/08/2023; Notification\|Accepted - CEP remains valid\|20/06/2022; Renewal\|CEP granted\|11/02/2021; Minor revision\|Accepted - CEP remains valid\|12/10/2020; Minor revision\|Accepted - CEP remains valid\|08/04/2020
2531	Clopidogrel hydrogen sulfate, Process B	PRAVEEN LABORATORIES PRIVATE LIMITED Jolwa Village IN	100033525;100052476	CEP 2017-247 - Rev 01	2025/03/19	Valid		Chemical	2025/03/19	Minor revision\|CEP granted\|19/03/2025; Renewal\|CEP granted\|19/12/2022
596	Bromocriptine mesilate	TAPI CZECH INDUSTRIES S.R.O. Opava CZ	100051642;100090678	CEP 2006-281 - Rev 04	2025/03/19	Valid		Chemical	2025/10/20	Minor revision\|Accepted - CEP remains valid\|20/10/2025; Notification\|CEP granted\|19/03/2025; Minor revision\|CEP granted\|05/02/2024; Minor revision\|Accepted - CEP remains valid\|11/06/2021
727	Lidocaine	SWATI SPENTOSE PRIVATE LIMITED Mumbai IN	100021605;100052219	CEP 2013-138 - Rev 03	2025/03/19	Valid		Chemical	2025/03/19	Minor revision\|CEP granted\|19/03/2025; Notification\|CEP granted\|16/09/2024; Minor revision\|CEP granted\|04/04/2024; Minor revision\|Rejected\|12/04/2023
2600	Olmesartan medoxomil, OQ process, crystalline form	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2024-040 - Rev 00	2025/03/19	Valid	19/03/2030	Chemical	2025/03/19	New application\|CEP granted\|19/03/2025
2856	Pirfenidone	CHEMO IBERICA S.A. Madrid ES	100001702;100008891	CEP 2018-127 - Rev 03	2025/03/19	Valid		Chemical	2025/03/19	Renewal\|CEP granted\|19/03/2025; Minor revision\|CEP granted\|19/04/2024; Minor revision\|CEP granted\|14/10/2021
3132	Mirabegron	ALIVUS LIFE SCIENCES LIMITED Mumbai IN	100023468;100069944	CEP 2024-056 - Rev 00	2025/03/19	Valid	19/03/2030	Chemical	2025/03/19	New application\|CEP granted\|19/03/2025

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)	-