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
2777	Pregabalin, Route code-PU, form-I, micronised, non-micronised, milled and non-milled	MSN PHARMACHEM PRIVATE LIMITED Sangareddy IN	100014794;100023345	CEP 2015-337 - Rev 03	2026/02/12	Valid		Chemical	2026/02/12	Minor revision\|CEP granted\|12/02/2026; Notification\|CEP granted\|25/10/2023; Minor revision\|CEP granted\|31/08/2022; Renewal\|CEP granted\|25/01/2022; Minor revision\|CEP granted\|21/04/2021
2616	Topiramate	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2020-130 - Rev 02	2026/02/12	Valid	13/07/2027	Chemical	2026/02/12	Minor revision\|CEP granted\|12/02/2026; Notification\|CEP granted\|06/03/2023; New application\|CEP granted\|13/07/2022
1084	Cetirizine dihydrochloride	INDOCO REMEDIES LIMITED Mumbai IN	100020134;100061295	CEP 2021-475 - Rev 01	2026/02/12	Valid	11/01/2028	Chemical	2026/02/12	Minor revision\|CEP granted\|12/02/2026; New application\|CEP granted\|11/01/2023
2591	Celecoxib, Site Khazipally	AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN	100046306;100076393	CEP 2023-194 - Rev 02	2026/02/12	Valid	16/08/2028	Chemical	2026/02/12	Minor revision\|CEP granted\|12/02/2026; Minor revision\|CEP granted\|09/12/2025; New application\|CEP granted\|16/08/2023
330	Gelatin, Bovine acid hide	ROUSSELOT B.V. Son En Breugel NL	100051434;100090148	CEP 2020-357 - Rev 01	2026/02/12	Valid		TSE	2026/02/12	Renewal\|CEP granted\|12/02/2026; New application\|CEP granted\|15/04/2021
3137	Dapagliflozin propylene glycol monohydrate, Micronised, non-micronised	ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN	100011833;100018698	CEP 2025-128 - Rev 00	2026/02/12	Valid	12/02/2031	Chemical	2026/02/12	New application\|CEP granted\|12/02/2026
1699	Mesalazine	D. K. PHARMA CHEM PRIVATE LIMITED Badlapur IN	100023552;100032697	CEP 2025-039 - Rev 00	2026/02/12	Valid	12/02/2031	Chemical	2026/02/12	New application\|CEP granted\|12/02/2026
2931	Sorafenib tosilate	CIPLA LIMITED Mumbai IN	100006004;100018147	CEP 2024-167 - Rev 00	2026/02/12	Valid	12/02/2031	Chemical	2026/02/12	New application\|CEP granted\|12/02/2026
1425	Fosfomycin trometamol	NANJING DORRA PHARMACEUTICAL TECHNOLOGY CO. LTD. Nanjing CN	100041071;100087393	CEP 2024-168 - Rev 01	2026/02/12	Valid	03/07/2030	Chemical	2026/02/12	Minor revision\|CEP granted\|12/02/2026; New application\|CEP granted\|03/07/2025
1519	Flurbiprofen	SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN	100008538;100018201	CEP 2003-154 - Rev 08	2026/02/11	Valid		Chemical	2026/02/11	Administrative procedure\|CEP granted\|11/02/2026; Minor revision\|CEP granted\|02/02/2026; Monograph revision\|CEP granted\|14/04/2022; Minor revision\|Rejected\|12/10/2020
11	Benzocaine, Standard and micronised	CHANGZHOU SUNLIGHT PHARMACEUTICAL CO., LTD. Benniu Town CN	100019106;100051966	CEP 2004-008 - Rev 07	2026/02/11	Valid		Chemical	2026/02/11	Minor revision\|CEP granted\|11/02/2026; Minor revision\|Accepted - CEP remains valid\|05/08/2025; Minor revision\|Accepted - CEP remains valid\|18/03/2024; Minor revision\|Accepted - CEP remains valid\|26/09/2023; Minor revision\|Accepted - CEP remains valid\|01/06/2023; Minor revision\|Accepted - CEP remains valid\|06/12/2022; Minor revision\|Accepted - CEP remains valid\|04/11/2020; Minor revision\|CEP granted\|15/06/2020
2570	Desloratadine	VASUDHA PHARMA CHEM LIMITED Hyderabad IN	100011811;100018603	CEP 2014-310 - Rev 03	2026/02/11	Valid		Chemical	2026/02/11	Minor revision\|CEP granted\|11/02/2026; Notification\|CEP granted\|30/01/2023; Notification\|CEP granted\|22/12/2021; Renewal\|CEP granted\|17/09/2020
375	Carbon dioxide	SOCIEDAD ESPANOLA DE CARBUROS METALICOS S.A. Cornella de Llobregat ES	100003675;100011298	CEP 2019-254 - Rev 01	2026/02/11	Valid		Chemical	2026/02/11	Renewal\|CEP granted\|11/02/2026
729	Naloxone hydrochloride dihydrate	SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH Minden DE	100012159;100092939	CEP 2011-126 - Rev 03	2026/02/11	Valid		Chemical	2026/02/11	Notification\|CEP granted\|11/02/2026; Minor revision\|CEP granted\|10/07/2024; Minor revision\|Accepted - CEP remains valid\|18/09/2020
2751	Valaciclovir hydrochloride hydrate, Micronised and non-micronised	AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN	100046306;100076393	CEP 2020-059 - Rev 04	2026/02/11	Valid		Chemical	2026/02/11	Renewal\|CEP granted\|11/02/2026; Minor revision\|CEP granted\|25/07/2025; Minor revision\|CEP granted\|25/03/2025; Minor revision\|CEP granted\|17/02/2022; New application\|CEP granted\|19/02/2021
2932	Rivaroxaban	NOSCH LABS PRIVATE LIMITED Hyderabad IN	100020550;100089573	CEP 2022-110 - Rev 01	2026/02/11	Valid	25/06/2029	Chemical	2026/02/11	Notification\|CEP granted\|11/02/2026; New application\|CEP granted\|25/06/2024
2578	Tizanidine hydrochloride	UNICHEM LABORATORIES LIMITED Mumbai IN	100005397;100093080	CEP 2024-473 - Rev 00	2026/02/11	Valid	11/02/2031	Chemical	2026/02/11	New application\|CEP granted\|11/02/2026
1711	Buspirone hydrochloride	COHANCE LIFESCIENCES LIMITED Mumbai IN	100011755;100090273	CEP 2025-096 - Rev 00	2026/02/11	Valid	11/02/2031	Chemical	2026/02/11	New application\|CEP granted\|11/02/2026
1425	Fosfomycin trometamol	ERCROS S.A. Aranjuez ES	100016091;100024873	CEP 2024-191 - Rev 00	2026/02/11	Valid	11/02/2031	Chemical	2026/02/11	New application\|CEP granted\|11/02/2026
2420	Tiotropium bromide monohydrate	SCL LIFESCIENCES LIMITED Sahibzada Ajit Singh Nagar IN	100011774;100018647	CEP 2025-365 - Rev 00	2026/02/11	Valid	11/02/2031	Chemical	2026/02/11	New application\|CEP granted\|11/02/2026

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)	-