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
2637	Pemetrexed disodium heptahydrate	DR. REDDY'S LABORATORIES LIMITED Hyderabad IN	100003991;100000217	CEP 2014-235 - Rev 01	2023/09/07	Valid		Chemical	2023/09/07	Monograph revision\|CEP granted\|07/09/2023; Major revision\|Rejected\|16/09/2022; Renewal\|CEP granted\|03/01/2022
2768	Fluticasone furoate	AURISCO PHARMACEUTICAL CO., LTD. Tiantai CN	100011968;100018590	CEP 2022-238 - Rev 00	2023/09/07	Valid	07/09/2028	Chemical	2023/09/07	New application\|CEP granted\|07/09/2023
2932	Rivaroxaban, Micronised	Moehs Iberica S.L. Rubi ES	100029092;100068825	CEP 2021-245 - Rev 01	2023/09/07	Valid	27/06/2028	Chemical	2023/09/07	Minor revision\|CEP granted\|07/09/2023; New application\|CEP granted\|27/06/2023
.	Collagen, Paste 04	3M DEUTSCHLAND GMBH Neuss DE	100003197;100008658	CEP 2003-152 - Rev 03	2023/09/07	Valid		TSE	2023/09/07	Administrative procedure\|CEP granted\|07/09/2023; Notification\|CEP granted\|21/08/2023
2359	Dorzolamide hydrochloride, Process 2	FDC Limited Mumbai IN	100011646;100021030	CEP 2023-236 - Rev 00	2023/09/07	Valid	07/09/2028	Chemical	2024/07/04	Minor revision\|Accepted - CEP remains valid\|04/07/2024; New application\|CEP granted\|07/09/2023
1322	Fenofibrate	Moehs Iberica S.L. Rubi ES	100029092;100068825	CEP 1998-128 - Rev 08	2023/09/07	Valid		Chemical	2023/09/07	Minor revision\|CEP granted\|07/09/2023; Minor revision\|Accepted - CEP remains valid\|03/08/2022; Minor revision\|Accepted - CEP remains valid\|04/06/2020
2702	Chlormadinone acetate, Micronised (grade 21), non-micronised	Farmabios SpA Gropello Cairoli IT	100011643;100021232	CEP 2018-122 - Rev 03	2023/09/07	Valid	25/11/2024	Chemical	2023/09/07	Minor revision\|CEP granted\|07/09/2023; Minor revision\|CEP granted\|18/12/2020; Minor revision\|CEP granted\|13/05/2020
2173	Gabapentin	SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN	100032307;100078783	CEP 2011-154 - Rev 03	2023/09/07	Valid		Chemical	2023/09/07	Administrative procedure\|CEP granted\|07/09/2023; Minor revision\|CEP granted\|30/08/2023
553	Ethambutol hydrochloride, Process-II	MICRO LABS LIMITED Bengaluru IN	100017819;100077269	CEP 2023-224 - Rev 00	2023/09/07	Valid	07/09/2028	Chemical	2023/09/07	New application\|CEP granted\|07/09/2023
729	Naloxone hydrochloride dihydrate	NORAMCO, LLC. Wilmington US	100048651;100080628	CEP 2011-055 - Rev 03	2023/09/06	Valid		Chemical	2023/09/06	Minor revision\|CEP granted\|06/09/2023; Notification\|CEP granted\|18/03/2022; Notification\|CEP granted\|05/03/2020
1724	Formoterol fumarate dihydrate, FRM	LUSOCHIMICA S.P.A. Lomagna IT	100018957;100027729	CEP 2011-262 - Rev 02	2023/09/05	Valid		Chemical	2023/09/06	Minor revision\|CEP granted\|06/09/2023; Monograph revision\|Accepted - CEP remains valid\|29/04/2022
2357	Dydrogesterone	YANGZHOU AURISCO PHARMACEUTICAL CO., LTD. Yangzhou City CN	100048379;100080110	CEP 2021-460 - Rev 02	2023/09/05	Valid	07/11/2027	Chemical	2023/09/06	Minor revision\|CEP granted\|06/09/2023; Minor revision\|CEP granted\|16/03/2023; New application\|CEP granted\|07/11/2022
260	Amoxicillin trihydrate, Enzymatic process	North China Pharmaceutical Group Semisyntech Co., Ltd. Shijiazhuang CN	100023274;100032418	CEP 2014-220 - Rev 02	2023/09/05	Valid		Chemical	2023/09/06	Minor revision\|CEP granted\|06/09/2023; Minor revision\|Accepted - CEP remains valid\|09/05/2023; Minor revision\|CEP granted\|24/06/2022; Notification\|Rejected\|28/04/2022; Renewal\|CEP granted\|09/11/2020
260	Amoxicillin trihydrate, Enzymatic process, compacted	North China Pharmaceutical Group Semisyntech Co., Ltd. Shijiazhuang CN	100023274;100032418	CEP 2017-009 - Rev 01	2023/09/05	Valid		Chemical	2023/09/06	Minor revision\|CEP granted\|06/09/2023; Minor revision\|Accepted - CEP remains valid\|06/10/2022; Renewal\|CEP granted\|02/03/2022
394	Hydrochlorothiazide	Changzhou Pharmaceutical Factory Jiangsu Province CN	100012704;100018611	CEP 2006-011 - Rev 04	2023/09/05	Valid		Chemical	2023/09/06	Minor revision\|CEP granted\|06/09/2023; Minor revision\|CEP granted\|28/04/2023; Notification\|CEP granted\|08/11/2021
68	Atropine sulfate	ROLABO OUTSOURCING, S.L. Zaragoza ES	100012139;100019601	CEP 2015-002 - Rev 01	2023/09/04	Valid		Chemical	2023/09/04	Minor revision\|CEP granted\|04/09/2023; Renewal\|CEP granted\|16/10/2020
2056	Atropine	ROLABO OUTSOURCING, S.L. Zaragoza ES	100012139;100019601	CEP 2015-255 - Rev 01	2023/09/04	Valid		Chemical	2023/09/04	Minor revision\|CEP granted\|04/09/2023; Renewal\|CEP granted\|24/06/2021; Minor revision\|Accepted - CEP remains valid\|09/10/2020
1724	Formoterol fumarate dihydrate, Micronised	FERMION OY Espoo FI	100011508;100020280	CEP 2015-215 - Rev 02	2023/09/04	Valid		Chemical	2023/09/04	Major revision\|CEP granted\|04/09/2023; Notification\|CEP granted\|07/11/2022; Notification\|Rejected\|28/06/2022; Monograph revision\|Accepted - CEP remains valid\|12/04/2022; Renewal\|CEP granted\|21/09/2021; Notification\|Accepted - CEP remains valid\|22/01/2020
1651	Clarithromycin, Process 2	SM BIOMED SDN BHD Sungai Petani MY	100018119;100026902	CEP 2022-483 - Rev 00	2023/09/04	Valid	04/09/2028	Chemical	2023/09/04	New application\|CEP granted\|04/09/2023
2778	Sitagliptin phosphate monohydrate	JUBILANT PHARMOVA LIMITED Nanjangud IN		R0-CEP 2021-175 - Rev 00	2023/08/31	Valid	31/08/2028	Chemical	2023/09/01	New application\|CEP granted\|01/09/2023

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)	-