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
2631	Rosuvastatin calcium, Amorphous Form, Micronised and Non-micronised	MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN	100011732;100018657	CEP 2015-188 - Rev 03	2025/02/19	Valid		Chemical	2025/02/19	Minor revision\|CEP granted\|19/02/2025; Minor revision\|CEP granted\|28/09/2022; Administrative procedure\|CEP granted\|05/11/2021; Renewal\|CEP granted\|06/10/2021; Minor revision\|CEP granted\|02/06/2021; Monograph revision\|Accepted - CEP remains valid\|16/04/2020
653	Baclofen, Standard, milled, micronised	ZAKŁADY FARMACEUTYCZNE POLPHARMA S.A. Starogard Gdański PL	100000470;100001572	CEP 2010-316 - Rev 07	2025/02/19	Valid		Chemical	2025/04/04	Minor revision\|Accepted - CEP remains valid\|04/04/2025; Monograph revision\|CEP granted\|19/02/2025; Notification\|CEP granted\|04/10/2024; Minor revision\|CEP granted\|27/08/2024; Minor revision\|Accepted - CEP remains valid\|30/05/2023; Administrative procedure\|CEP granted\|03/03/2021; Minor revision\|CEP granted\|18/02/2021
2591	Celecoxib	PharmaZell GmbH Raubling DE	100012552;100021381	CEP 2012-151 - Rev 03	2025/02/19	Valid		Chemical	2025/02/19	Major revision\|CEP granted\|19/02/2025; Notification\|CEP granted\|09/11/2023; Notification\|CEP granted\|18/06/2020
185	Potassium chloride	MACCO ORGANIQUES, S.R.O. Bruntál CZ	100017613;100026377	CEP 2018-159 - Rev 01	2025/02/19	Valid		Chemical	2025/02/19	Renewal\|CEP granted\|19/02/2025
294	Sulfadiazine	ANDHRA ORGANICS LIMITED Pydibhimavaram Village IN	100023796;100032964	CEP 2022-411 - Rev 00	2025/02/19	Valid	19/02/2030	Chemical	2025/02/19	New application\|CEP granted\|19/02/2025
457	Etacrynic Acid	BIOPHORE INDIA PHARMACEUTICALS PVT. LTD. Hyderabad IN	100028906;100063062	CEP 2018-288 - Rev 01	2025/02/19	Valid		Chemical	2025/02/19	Renewal\|CEP granted\|19/02/2025
167	Ampicillin	INNER MONGOLIA CHANGSHENG PHARMACEUTICAL CO., LTD. Tuoketuo CN	100019603;100028364	CEP 2024-308 - Rev 00	2025/02/19	Valid	19/02/2030	Chemical	2025/02/19	New application\|CEP granted\|19/02/2025
2103	Propafenone hydrochloride	CHANGZHOU RUIMING PHARMACEUTICAL CO., LTD. Chunjiang Town CN	100025203;100034409	CEP 2023-038 - Rev 00	2025/02/18	Valid	18/02/2030	Chemical	2025/02/18	New application\|CEP granted\|18/02/2025
1311	Dinoprostone	KYOWA PHARMA CHEMICAL CO., LTD. Takaoka JP	100012459;100023014	CEP 2003-029 - Rev 03	2025/02/18	Valid		Chemical	2025/02/18	Notification\|CEP granted\|18/02/2025; Administrative procedure\|CEP granted\|09/08/2022; Notification\|Accepted - CEP remains valid\|05/07/2022
199	Oxytetracycline dihydrate, Process II	YANGZHOU LIBERTY PHARMACEUTICAL CO., LTD. Yangzhou CN	100023496;100032638	CEP 2018-291 - Rev 02	2025/02/18	Valid		Chemical	2025/02/18	Administrative procedure\|CEP granted\|18/02/2025; Monograph revision\|Accepted - CEP remains valid\|19/12/2024; Renewal\|CEP granted\|30/08/2024
2576	Voriconazole	ANHUI POLY PHARM. CO., LTD. Anqing CN	100047725;100078876	CEP 2023-327 - Rev 00	2025/02/18	Valid	18/02/2030	Chemical	2025/02/18	New application\|CEP granted\|18/02/2025
198	Oxytetracycline hydrochloride, For use in the manufacture of parenteral preparations	YANGZHOU LIBERTY PHARMACEUTICAL CO., LTD. Yangzhou CN	100023496;100032638	CEP 2018-119 - Rev 04	2025/02/18	Valid		Chemical	2025/02/18	Administrative procedure\|CEP granted\|18/02/2025; Monograph revision\|Accepted - CEP remains valid\|19/12/2024; Renewal\|CEP granted\|19/04/2024; Minor revision\|CEP granted\|23/06/2022; Monograph revision\|CEP granted\|05/06/2020
2583	Montelukast sodium, Amorphous, non-micronised and micronised	MSN PHARMACHEM PRIVATE LIMITED Sangareddy District IN	100014794;100023345	CEP 2012-091 - Rev 01	2025/02/17	Valid		Chemical	2025/02/17	Monograph revision\|CEP granted\|17/02/2025
883	Calcitriol	CERBIOS-PHARMA SA Barbengo CH	100015546;100024284	CEP 2012-356 - Rev 01	2025/02/17	Valid		Chemical and TSE	2025/02/17	Monograph revision\|CEP granted\|17/02/2025; Minor revision\|Accepted - CEP remains valid\|23/08/2022; Notification\|Accepted - CEP remains valid\|20/09/2021
1563	Simvastatin	SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN	100008538;100018201	CEP 2001-384 - Rev 09	2025/02/17	Valid		Chemical	2025/02/17	Minor revision\|CEP granted\|17/02/2025; Notification\|Rejected\|14/01/2025
2856	Pirfenidone	ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN	100006039;100002980	CEP 2018-147 - Rev 02	2025/02/17	Valid		Chemical	2025/10/14	Minor revision\|Accepted - CEP remains valid\|14/10/2025; Renewal\|CEP granted\|17/02/2025; Minor revision\|CEP granted\|01/02/2023; Minor revision\|Accepted - CEP remains valid\|04/02/2021
1455	Ofloxacin	SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN	100008538;100018201	CEP 2000-106 - Rev 10	2025/02/17	Valid		Chemical	2025/02/17	Minor revision\|CEP granted\|17/02/2025; Minor revision\|CEP granted\|28/02/2024; Minor revision\|Accepted - CEP remains valid\|17/03/2022; Notification\|CEP granted\|29/07/2021; Minor revision\|CEP granted\|01/12/2020
2288	Citalopram hydrobromide	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2009-248 - Rev 05	2025/02/17	Valid		Chemical	2025/02/17	Notification\|CEP granted\|17/02/2025; Minor revision\|CEP granted\|17/06/2024; Minor revision\|Accepted - CEP remains valid\|04/09/2023; Minor revision\|CEP granted\|14/10/2021; Notification\|Rejected\|06/08/2021
2641	Dutasteride	SHAKTI LIFESCIENCE PRIVATE LIMITED Mumbai IN	100048889;100089578	CEP 2022-172 - Rev 00	2025/02/17	Valid	17/02/2030	Chemical	2025/02/17	New application\|CEP granted\|17/02/2025
2254	Moxifloxacin hydrochloride	CHONGQING HUAPONT PHARMACEUTICAL CO., LTD. Chongqing CN	100038938;100061197	CEP 2021-458 - Rev 00	2025/02/17	Valid	17/02/2030	Chemical	2025/02/17	New application\|CEP granted\|17/02/2025

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)	-