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-PB, crystalline form-1, micronised, non-micronised, milled and non-milled	MSN PHARMACHEM PRIVATE LIMITED Sangareddy IN	100014794;100023345	CEP 2015-324 - Rev 02	2026/03/24	Valid		Chemical	2026/03/24	Minor revision\|CEP granted\|24/03/2026; Notification\|CEP granted\|25/10/2023; Renewal\|CEP granted\|09/11/2021; Minor revision\|Accepted - CEP remains valid\|20/11/2020
2535	Levetiracetam	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2010-245 - Rev 05	2026/03/24	Valid		Chemical	2026/03/24	Minor revision\|CEP granted\|24/03/2026; Minor revision\|Accepted - CEP remains valid\|05/11/2024; Major revision\|Rejected\|24/10/2024; Notification\|CEP granted\|12/01/2024; Notification\|Accepted - CEP remains valid\|13/09/2023; Minor revision\|Accepted - CEP remains valid\|02/06/2020
2296	Pantoprazole sodium sesquihydrate	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy IN	100051463;100098142	CEP 2008-244 - Rev 07	2026/03/24	Valid		Chemical	2026/03/24	Minor revision\|CEP granted\|24/03/2026; Notification\|CEP granted\|25/07/2024; Minor revision\|CEP granted\|07/12/2022; Minor revision\|CEP granted\|23/08/2021
1491	Amlodipine besilate	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2006-130 - Rev 06	2026/03/24	Valid		Chemical	2026/03/24	Monograph revision\|CEP granted\|24/03/2026; Notification\|CEP granted\|29/11/2023; Minor revision\|Accepted - CEP remains valid\|07/09/2021
3039	Dronedarone hydrochloride	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2020-051 - Rev 02	2026/03/24	Valid		Chemical	2026/03/24	Renewal\|CEP granted\|24/03/2026; Notification\|CEP granted\|16/01/2024; Minor revision\|Accepted - CEP remains valid\|05/04/2023; New application\|CEP granted\|25/05/2021
2866	Gefitinib, Route code-GNB, micronised and non-micronised	MSN LABORATORIES PRIVATE LIMITED Kandi Mandal IN	100011732;100084010	CEP 2025-590 - Rev 00	2026/03/24	Valid	24/03/2031	Chemical	2026/03/24	New application\|CEP granted\|24/03/2026
2154	Telmisartan, Process-II	MICRO LABS LIMITED Bengaluru IN	100017819;100077269	CEP 2020-388 - Rev 03	2026/03/24	Valid		Chemical	2026/03/24	Renewal\|CEP granted\|24/03/2026; Minor revision\|CEP granted\|20/08/2025; Minor revision\|CEP granted\|07/10/2021; New application\|CEP granted\|15/03/2021
2741	Sulfadimethoxine	ZHEJIANG JIUZHOU PHARMACEUTICAL CO. LTD. Taizhou CN	100011841;100018560	CEP 2025-053 - Rev 00	2026/03/24	Valid	24/03/2031	Chemical	2026/03/24	New application\|CEP granted\|24/03/2026
2787	Esomeprazole magnesium dihydrate, Unit IV	NOSCH LABS PRIVATE LIMITED Hyderabad IN	100020550;100089573	CEP 2020-344 - Rev 01	2026/03/24	Valid		Chemical	2026/03/24	Renewal\|CEP granted\|24/03/2026; New application\|CEP granted\|18/01/2021
2423	Valsartan, Process III	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy IN	100051463;100098142	CEP 2024-113 - Rev 03	2026/03/24	Valid	14/06/2029	Chemical	2026/03/24	Minor revision\|CEP granted\|24/03/2026; Notification\|Rejected\|26/02/2026; Notification\|CEP granted\|07/10/2025; Notification\|CEP granted\|25/07/2024; New application\|CEP granted\|14/06/2024
561	Methylprednisolone	SHANDONG SIRUI PHARMACEUTICAL CO., LTD. Heze CN	100049295;100083729	CEP 2024-523 - Rev 00	2026/03/24	Valid	24/03/2031	Chemical	2026/03/24	New application\|CEP granted\|24/03/2026
619	Levomenthol	JINDAL DRUGS PRIVATE LIMITED Navi Mumbai IN	100024387;100101409	CEP 2018-211 - Rev 01	2026/03/23	Valid		Chemical	2026/03/23	Renewal\|CEP granted\|23/03/2026
851	Pentoxifylline	SUPRIYA LIFESCIENCE LIMITED Mumbai IN	100015796;100024574	CEP 2018-294 - Rev 01	2026/03/23	Valid		Chemical	2026/03/23	Renewal\|CEP granted\|23/03/2026
2219	Lansoprazole, LANCO Process	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2014-074 - Rev 02	2026/03/23	Valid		Chemical	2026/03/23	Minor revision\|CEP granted\|23/03/2026; Notification\|CEP granted\|27/11/2024; Minor revision\|Accepted - CEP remains valid\|29/06/2023
2167	Hyoscine	ALKALOIDS PRIVATE LIMITED Secunderabad IN	100021602;100041426	CEP 2020-045 - Rev 02	2026/03/23	Valid		Chemical	2026/03/23	Renewal\|CEP granted\|23/03/2026; Transfer of holdership\|CEP granted\|11/12/2023; New application\|CEP granted\|01/04/2021
992	Cefuroxime sodium, Sterile	TITAN PHARMACEUTICAL CO., LTD. (GUANGDONG) Heyuan City CN	100024682;100033865	CEP 2014-335 - Rev 01	2026/03/23	Valid		Chemical	2026/03/23	Major revision\|CEP granted\|23/03/2026; Renewal\|CEP granted\|17/01/2022; Minor revision\|CEP granted\|29/07/2021
3132	Mirabegron	ZYDUS LIFESCIENCES LIMITED Vadodara IN	100005979;100074301	CEP 2024-378 - Rev 00	2026/03/23	Valid	23/03/2031	Chemical	2026/03/23	New application\|CEP granted\|23/03/2026
2215	Iodixanol	JIANGSU YUTIAN PHARMACEUTICAL CO., LTD. Lianyungang CN	100023388;100032524	CEP 2021-497 - Rev 01	2026/03/23	Valid	20/04/2028	Chemical	2026/03/23	Minor revision\|CEP granted\|23/03/2026; New application\|CEP granted\|20/04/2023
2787	Esomeprazole magnesium dihydrate, Site-II	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2020-390 - Rev 02	2026/03/23	Valid		Chemical	2026/03/23	Renewal\|CEP granted\|23/03/2026; Notification\|CEP granted\|19/01/2024; New application\|CEP granted\|26/03/2021
2191	Atorvastatin calcium, Trihydrate, micronised and non-micronised	MSN LIFE SCIENCES PRIVATE LIMITED Kamareddy IN	100018316;100070723	CEP 2020-177 - Rev 01	2026/03/23	Valid	19/03/2029	Chemical	2026/03/23	Major revision\|CEP granted\|23/03/2026; Minor revision\|Rejected\|14/10/2025; New application\|CEP granted\|19/03/2024

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)	-