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
2594	Duloxetine hydrochloride	EGIS Pharmaceuticals PLC Budapest HU	100001091;100001662	CEP 2023-144 - Rev 00	2024/12/19	Valid	19/12/2029	Chemical	2024/12/20	New application\|CEP granted\|20/12/2024
2778	Sitagliptin phosphate monohydrate, Process II	AMI LIFESCIENCES PRIVATE LIMITED Karakhadi IN	100021822;100030527	CEP 2024-249 - Rev 00	2024/12/19	Valid	19/12/2029	Chemical	2024/12/20	New application\|CEP granted\|20/12/2024
491	Ethylmorphine Hydrochloride	ALCALIBER S.A.U. Madrid ES	100020633;100087731	CEP 2018-253 - Rev 02	2024/12/18	Valid		Chemical	2024/12/18	Renewal\|CEP granted\|18/12/2024; Notification\|CEP granted\|23/01/2024
2787	Esomeprazole magnesium dihydrate, Micronized, Non-micronized	QUIMICA SINTETICA S.A. Alcala De Henares ES	100012121;100019020	CEP 2023-283 - Rev 00	2024/12/18	Valid	18/12/2029	Chemical	2024/12/18	New application\|CEP granted\|18/12/2024
2219	Lansoprazole	NOSCH LABS PRIVATE LIMITED Hyderabad IN	100020550;100029297	CEP 2010-309 - Rev 02	2024/12/18	Valid		Chemical	2024/12/18	Minor revision\|CEP granted\|18/12/2024; Notification\|CEP granted\|06/08/2021
49	Paracetamol, 14 micronised grades	Atabay Kimya Sanayi Ve Ticaret A.S. Istanbul TR	100017338;100026137	CEP 1995-050 - Rev 06	2024/12/18	Valid		Chemical	2024/12/18	Minor revision\|CEP granted\|18/12/2024; Monograph revision\|CEP granted\|08/02/2023
2064	Chondroitin sulfate sodium, Terrestrial origin, Process B	BIOIBERICA, S.A.U. Palafolls ES	100000136;100043853	CEP 2023-243 - Rev 02	2024/12/18	Valid	25/09/2028	Chemical and TSE	2024/12/18	Minor revision\|CEP granted\|18/12/2024; Administrative procedure\|CEP granted\|25/10/2023; New application\|CEP granted\|25/09/2023
883	Calcitriol, Process 2 (F007V1)	FORMOSA LABORATORIES, INC. Taoyuan TW	100011879;100018688	CEP 2020-150 - Rev 02	2024/12/18	Valid	22/10/2026	Chemical	2024/12/18	Monograph revision\|CEP granted\|18/12/2024; Administrative procedure\|CEP granted\|18/11/2021; New application\|CEP granted\|22/10/2021
883	Calcitriol	FORMOSA LABORATORIES, INC. Taoyuan TW	100011879;100018688	CEP 2009-377 - Rev 02	2024/12/18	Valid		Chemical and TSE	2024/12/18	Monograph revision\|CEP granted\|18/12/2024
1442	Leuprorelin	SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN	100008538;100018201	CEP 2014-278 - Rev 01	2024/12/18	Valid		Chemical	2024/12/19	Minor revision\|CEP granted\|19/12/2024; Renewal\|CEP granted\|26/02/2021
2410	2,4-dichlorobenzyl alcohol	BIOXERA PHARMA PRIVATE LTD. Ambernath IN	100023820;100032988	CEP 2014-346 - Rev 01	2024/12/18	Valid		Chemical	2024/12/19	Minor revision\|CEP granted\|19/12/2024; Renewal\|CEP granted\|28/01/2022
2791	Clopidogrel hydrochloride	KRKA, d.d., Novo mesto Novo mesto SI	100000627;100009540	CEP 2018-251 - Rev 01	2024/12/18	Valid		Chemical	2024/12/19	Renewal\|CEP granted\|19/12/2024; Minor revision\|Accepted - CEP remains valid\|25/03/2022
2583	Montelukast sodium	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2012-318 - Rev 02	2024/12/18	Valid		Chemical	2024/12/19	Monograph revision\|CEP granted\|19/12/2024; Minor revision\|CEP granted\|23/05/2023; Minor revision\|Accepted - CEP remains valid\|09/12/2021
1573	Sumatriptan succinate, Micronised and Non-micronised	MSN PHARMACHEM PRIVATE LIMITED Sangareddy District IN	100014794;100023345	CEP 2009-096 - Rev 05	2024/12/18	Valid		Chemical	2024/12/19	Minor revision\|CEP granted\|19/12/2024; Notification\|CEP granted\|25/10/2023; Minor revision\|CEP granted\|27/07/2022; Minor revision\|CEP granted\|11/03/2021
2933	Deferasirox	ZHEJIANG HENGKANG PHARMACEUTICAL CO., LTD. Sanmen CN	100034135;100082085	CEP 2024-292 - Rev 00	2024/12/18	Valid	18/12/2029	Chemical	2024/12/19	New application\|CEP granted\|19/12/2024
2020	Rilmenidine dihydrogen phosphate	ZENTIVA K.S. Prague CZ	100004108;100002580	CEP 2023-124 - Rev 00	2024/12/18	Valid	18/12/2029	Chemical	2024/12/19	New application\|CEP granted\|19/12/2024
603	Disulfiram, Milled	ZAKŁADY FARMACEUTYCZNE POLPHARMA S.A. Starogard Gdański PL	100000470;100001572	CEP 2022-090 - Rev 01	2024/12/18	Valid	13/08/2029	Chemical	2024/12/19	Notification\|CEP granted\|19/12/2024; New application\|CEP granted\|13/08/2024
312	Betamethasone	AURISCO PHARMACEUTICAL CO., LTD. Tiantai CN	100011968;100018590	CEP 2022-196 - Rev 01	2024/12/18	Valid	13/11/2029	Chemical	2024/12/19	Minor revision\|CEP granted\|19/12/2024; New application\|CEP granted\|13/11/2024
1654	Lymecycline	KOPRAN RESEARCH LABORATORIES LIMITED Mumbai IN	100033667;100081898	CEP 2020-040 - Rev 01	2024/12/18	Valid	18/09/2029	Chemical	2024/12/19	Minor revision\|CEP granted\|19/12/2024; New application\|CEP granted\|18/09/2024
2531	Clopidogrel hydrogen sulfate	SHANDONG LIXIN PHARMACEUTICAL CO. LTD. Zibo CN	100048250;100079839	CEP 2022-450 - Rev 00	2024/12/17	Valid	17/12/2029	Chemical	2024/12/17	New application\|CEP granted\|17/12/2024

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)	-