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
829	Hydralazine hydrochloride	D. K. PHARMA CHEM PRIVATE LIMITED Badlapur IN	100023552;100032697	CEP 2023-431 - Rev 00	2025/08/14	Valid	14/08/2030	Chemical	2025/08/14	New application\|CEP granted\|14/08/2025
1084	Cetirizine dihydrochloride	IPCA LABORATORIES LIMITED Mumbai IN	100011685;100018680	CEP 2006-309 - Rev 02	2025/08/13	Valid		Chemical	2025/08/13	Minor revision\|CEP granted\|13/08/2025; Notification\|Accepted - CEP remains valid\|23/06/2023
1519	Flurbiprofen, Process 3	FDC Limited Mumbai IN	100011646;100021030	CEP 2025-225 - Rev 00	2025/08/13	Valid	13/08/2030	Chemical	2025/08/13	New application\|CEP granted\|13/08/2025
1764	Rocuronium bromide	MANKIND PHARMA LIMITED New Delhi IN	100040218;100065486	CEP 2024-337 - Rev 00	2025/08/13	Valid	13/08/2030	Chemical	2025/08/13	New application\|CEP granted\|13/08/2025
199	Oxytetracycline dihydrate	INNER MONGOLIA HUASHU BIOLOGICAL TECHNOLOGY CO.LTD Tongliao City CN	100052898;100093261	CEP 2018-238 - Rev 01	2025/08/13	Valid		Chemical	2025/08/13	Renewal\|CEP granted\|13/08/2025
1450	Mupirocin, Process B	FUJIAN COMHONY BIOTECHNOLOGY CO., LTD. Fuqing CN	100043888;100072481	CEP 2022-391 - Rev 01	2025/08/13	Valid	29/11/2028	Chemical and TSE	2025/08/13	Minor revision\|CEP granted\|13/08/2025; New application\|CEP granted\|29/11/2023
2223	Glimepiride	MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN	100018316;100070723	CEP 2022-111 - Rev 01	2025/08/12	Valid	05/07/2029	Chemical	2025/08/12	Minor revision\|CEP granted\|12/08/2025; New application\|CEP granted\|05/07/2024
1705	Sertraline hydrochloride, Process IVB	SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN	100008538;100018201	CEP 2017-264 - Rev 01	2025/08/12	Valid		Chemical	2025/08/12	Minor revision\|CEP granted\|12/08/2025; Renewal\|CEP granted\|05/05/2023; Minor revision\|Accepted - CEP remains valid\|07/06/2022; Minor revision\|Accepted - CEP remains valid\|24/02/2022; Administrative procedure\|CEP granted\|10/11/2021; Major revision\|CEP granted\|25/10/2021; Notification\|CEP granted\|30/03/2021; Minor revision\|Accepted - CEP remains valid\|05/03/2021; Notification\|Accepted - CEP remains valid\|02/12/2020; Notification\|Accepted - CEP remains valid\|24/04/2020
1058	Vancomycin hydrochloride, Precipitated	LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN	100020920;100029633	CEP 2012-235 - Rev 04	2025/08/12	Valid		Chemical	2025/08/12	Administrative procedure\|CEP granted\|12/08/2025; Minor revision\|CEP granted\|25/07/2025; Monograph revision\|CEP granted\|28/10/2024; Notification\|Accepted - CEP remains valid\|06/06/2024; Minor revision\|CEP granted\|31/03/2023; Minor revision\|Rejected\|13/01/2023; Notification\|Accepted - CEP remains valid\|27/05/2021
2778	Sitagliptin phosphate monohydrate, Process II	ZHEJIANG JINGSHENG PHARMACEUTICAL CO., LTD. Taizhou City CN	100048181;100079705	CEP 2023-453 - Rev 01	2025/08/12	Valid	06/05/2029	Chemical	2025/08/12	Transfer of holdership\|CEP granted\|12/08/2025; New application\|CEP granted\|06/05/2024
2423	Valsartan	NINGBO MENOVO PHARMACEUTICAL CO., LTD. Ningbo CN	100030313;100047776	CEP 2019-258 - Rev 02	2025/08/12	Valid		Chemical	2025/10/27	Renewal\|Accepted - CEP remains valid\|27/10/2025; Minor revision\|CEP granted\|12/08/2025; Major revision\|CEP granted\|09/07/2024; Minor revision\|Accepted - CEP remains valid\|13/10/2022; Notification\|Accepted - CEP remains valid\|01/12/2021; Minor revision\|Accepted - CEP remains valid\|25/06/2021
1734	Terbinafine hydrochloride	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2007-146 - Rev 08	2025/08/11	Valid		Chemical	2025/08/11	Minor revision\|CEP granted\|11/08/2025; Minor revision\|Accepted - CEP remains valid\|21/06/2024; Notification\|CEP granted\|05/03/2024; Notification\|CEP granted\|13/12/2023; Notification\|Accepted - CEP remains valid\|20/12/2022; Minor revision\|CEP granted\|14/08/2020
721	Ibuprofen	HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO., LTD. Jingmen City CN	100020377;100029131	CEP 2002-099 - Rev 08	2025/08/11	Valid		Chemical	2025/08/11	Minor revision\|CEP granted\|11/08/2025; Minor revision\|Accepted - CEP remains valid\|04/05/2023; Notification\|CEP granted\|07/12/2020; Notification\|CEP granted\|07/08/2020
2338	Mirtazapine	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2007-062 - Rev 05	2025/08/11	Valid		Chemical	2025/08/11	Minor revision\|CEP granted\|11/08/2025; Notification\|CEP granted\|13/12/2023; Minor revision\|Accepted - CEP remains valid\|20/02/2020
2071	Milk thistle dry extract, refined and standardised, DER 24-27:1	TAPI CZECH INDUSTRIES S.R.O. Opava CZ	100051642;100090678	CEP 2017-262 - Rev 03	2025/08/11	Valid		Herbal	2025/08/11	Minor revision\|CEP granted\|11/08/2025; Renewal\|CEP granted\|19/12/2024; Monograph revision\|Accepted - CEP remains valid\|15/03/2024; Minor revision\|CEP granted\|04/02/2021
1611	Diosmin, Process II, non-micronised and micronised powder	CHENGDU OKAY PHARMACEUTICAL CO. LTD. Qionglai CN	100024058;100033233	CEP 2017-087 - Rev 01	2025/08/11	Valid		Chemical	2025/08/11	Minor revision\|CEP granted\|11/08/2025; Renewal\|CEP granted\|13/06/2023
1181	Buprenorphine hydrochloride	AZAD PHARMA AG Schaffhausen CH	100009425;100030643	CEP 2024-252 - Rev 00	2025/08/11	Valid	11/08/2030	Chemical	2025/08/11	New application\|CEP granted\|11/08/2025
685	Povidone, K90 - Triethanolamine process	STAR-TECH & JRS SPECIALTY PRODUCTS CO., LTD. Chongqing CN	100052592;100092620	CEP 2025-278 - Rev 00	2025/08/11	Valid	11/08/2030	Chemical	2025/08/11	New application\|CEP granted\|11/08/2025
2154	Telmisartan, Process II	ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN	100012174;100018701	CEP 2025-215 - Rev 00	2025/08/11	Valid	11/08/2030	Chemical	2025/08/11	New application\|CEP granted\|11/08/2025
809	Betamethasone dipropionate	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2000-223 - Rev 09	2025/08/08	Valid		Chemical	2025/08/08	Minor revision\|CEP granted\|08/08/2025; Notification\|CEP granted\|09/08/2024; Notification\|Accepted - CEP remains valid\|02/01/2024; Notification\|Accepted - CEP remains valid\|14/12/2022; Notification\|CEP granted\|25/11/2021; Minor revision\|CEP granted\|16/09/2021; Notification\|Rejected\|27/07/2021; Notification\|Accepted - CEP remains valid\|12/06/2020

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)	-