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
2234	Meropenem trihydrate, Synthetic origin, Sterile, Process II	SHENZHEN HAIBIN PHARMACEUTICAL CO., LTD. Shenzhen City CN	100021561;100030252	CEP 2024-097 - Rev 01	2025/08/19	Valid	11/06/2030	Chemical	2025/08/19	Administrative procedure\|CEP granted\|19/08/2025; New application\|CEP granted\|11/06/2025
2154	Telmisartan	RAGHAVA LIFE SCIENCES PRIVATE LIMITED Hyderabad IN	100048921;100081885	CEP 2024-253 - Rev 00	2025/08/19	Valid	19/08/2030	Chemical	2025/08/19	New application\|CEP granted\|19/08/2025
1472	Sodium hyaluronate, Intrinsic viscosity: 1.62m3/kg - 1.70m3/kg and 2.28m3/kg - 3.78m3/kg; from fermentation; for parenteral administration, including intra-articular administration and intra-ocular use	MARUHA NICHIRO CORP. Utsunomiya JP	100021754;100095570	CEP 2007-242 - Rev 02	2025/08/19	Valid		Chemical	2025/08/19	Minor revision\|CEP granted\|19/08/2025; Minor revision\|Accepted - CEP remains valid\|28/03/2023; Notification\|CEP granted\|06/08/2021
123	Sodium benzoate	MSN LIFE SCIENCES PRIVATE LIMITED Medak IN	100018316;100027671	CEP 2024-580 - Rev 00	2025/08/19	Valid	19/08/2030	Chemical	2025/08/19	New application\|CEP granted\|19/08/2025
2735	Gadobutrol monohydrate, Process 2	VIWIT PHARMACEUTICAL CO. LTD Tengzhou CN	100049012;100082223	CEP 2025-342 - Rev 00	2025/08/19	Valid	19/08/2030	Chemical	2025/08/19	New application\|CEP granted\|19/08/2025
2406	Anastrozole	MAC CHEM PRODUCTS (INDIA) PRIVATE LIMITED Tarapur IN	100023737;100032907	CEP 2025-063 - Rev 00	2025/08/19	Valid	19/08/2030	Chemical	2025/08/19	New application\|CEP granted\|19/08/2025
1711	Buspirone hydrochloride	MEDILUX LABORATORIES PRIVATE LIMITED Pithampur IN	100023732;100032901	CEP 2024-322 - Rev 00	2025/08/19	Valid	19/08/2030	Chemical	2025/08/19	New application\|CEP granted\|19/08/2025
2766	Exemestane, micronized	FARMABIOS S.p.A Gropello Cairoli IT	100011643;100021232	CEP 2018-274 - Rev 01	2025/08/18	Valid		Chemical	2025/08/18	Renewal\|CEP granted\|18/08/2025
1058	Vancomycin hydrochloride, Sterile	XELLIA PHARMACEUTICALS APS Copenhagen S DK	100004144;100002734	CEP 2006-245 - Rev 03	2025/08/18	Valid		Chemical	2025/08/18	Minor revision\|CEP granted\|18/08/2025; Minor revision\|Accepted - CEP remains valid\|20/08/2024; Notification\|Accepted - CEP remains valid\|15/03/2023; Minor revision\|Accepted - CEP remains valid\|20/04/2022; Minor revision\|Accepted - CEP remains valid\|04/02/2021
991	Ceftriaxone sodium, Sterile	QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN	100033695;100052910	CEP 2006-017 - Rev 04	2025/08/18	Valid		Chemical	2025/08/18	Major revision\|CEP granted\|18/08/2025; Minor revision\|Accepted - CEP remains valid\|05/01/2022
2631	Rosuvastatin calcium	ZHEJIANG HONGYUAN PHARMACEUTICAL CO., LTD. Taizhou CN	100039285;100077346	CEP 2024-279 - Rev 00	2025/08/18	Valid	18/08/2030	Chemical	2025/08/18	New application\|CEP granted\|18/08/2025
2631	Rosuvastatin calcium	MELODY HEALTHCARE PRIVATE LIMITED Mumbai IN	100014822;100073679	CEP 2015-197 - Rev 02	2025/08/18	Valid		Chemical	2025/08/18	Minor revision\|CEP granted\|18/08/2025; Major revision\|CEP granted\|09/12/2024; Renewal\|CEP granted\|17/08/2022; Major revision\|Rejected\|11/03/2022; Notification\|Rejected\|21/10/2021; Monograph revision\|Accepted - CEP remains valid\|14/04/2020
3139	Brivaracetam, Form-A	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2024-596 - Rev 00	2025/08/18	Valid	18/08/2030	Chemical	2025/08/18	New application\|CEP granted\|18/08/2025
2531	Clopidogrel hydrogen sulfate	APARNA PHARMACEUTICALS PRIVATE LIMITED Hyderabad IN	100039108;100081311	CEP 2023-461 - Rev 00	2025/08/18	Valid	18/08/2030	Chemical	2025/08/18	New application\|CEP granted\|18/08/2025
1200	Dobutamine hydrochloride	BIOINDUSTRIA L.I.M. S.P.A. Novi Ligure IT	100001870;100092872	CEP 2004-261 - Rev 02	2025/08/14	Valid		Chemical	2025/08/14	Minor revision\|CEP granted\|14/08/2025
3132	Mirabegron	BIOCON LIMITED Bengaluru IN	100011487;100018595	CEP 2023-460 - Rev 00	2025/08/14	Valid	14/08/2030	Chemical	2025/08/14	New application\|CEP granted\|14/08/2025
1983	Josamycin	MICROBIOPHARM JAPAN CO., LTD. Tokyo JP	100012325;100088928	CEP 2021-502 - Rev 02	2025/08/14	Valid	29/06/2028	Chemical	2025/08/14	Minor revision\|CEP granted\|14/08/2025; Minor revision\|CEP granted\|01/07/2024; New application\|CEP granted\|29/06/2023
369	Azathioprine	RPG LIFE SCIENCES LIMITED Navi Mumbai IN	100017119;100025920	CEP 2001-341 - Rev 11	2025/08/14	Valid		Chemical	2025/08/14	Minor revision\|CEP granted\|14/08/2025; Notification\|CEP granted\|12/04/2024; Minor revision\|CEP granted\|14/03/2024; Minor revision\|CEP granted\|22/08/2022
106	Hyoscine hydrobromide	ALKALOIDS PRIVATE LIMITED Secunderabad IN	100021602;100041426	CEP 2019-152 - Rev 02	2025/08/14	Valid		Chemical	2025/08/14	Renewal\|CEP granted\|14/08/2025; Transfer of holdership\|CEP granted\|11/12/2023
931	Metformin Hydrochloride, 2nd line	NINGXIA HENGKANG TECHNOLOGY CO., LTD. Yinchuan CN	100049743;100086705	CEP 2024-237 - Rev 02	2025/08/14	Valid	02/08/2029	Chemical	2025/08/14	Major revision\|CEP granted\|14/08/2025; Minor revision\|CEP granted\|23/12/2024; New application\|CEP granted\|02/08/2024

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)	-