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
68	Atropine sulfate	FLOWCHEM PHARMA PRIVATE LIMITED Sri Sathya Sai IN	100054650;100096908	CEP 2023-209 - Rev 00	2025/07/22	Valid	22/07/2030	Chemical	2025/07/23	New application\|CEP granted\|23/07/2025
1243	Mitoxantrone hydrochloride	WUHAN CALMLAND PHARMACEUTICALS CO., LTD. Wuhan CN	100049301;100083738	CEP 2023-342 - Rev 00	2025/07/22	Valid	22/07/2030	Chemical	2025/07/23	New application\|CEP granted\|23/07/2025
1742	Esketamine hydrochloride	AREVIPHARMA GMBH Radebeul DE	100011616;100022155	CEP 2022-404 - Rev 01	2025/07/22	Valid	21/06/2028	Chemical	2025/07/23	Minor revision\|CEP granted\|23/07/2025; New application\|CEP granted\|21/06/2023
2334	Letrozole, Form-III	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2012-145 - Rev 03	2025/07/22	Valid		Chemical	2025/07/23	Minor revision\|CEP granted\|23/07/2025; Minor revision\|CEP granted\|22/02/2023; Monograph revision\|Accepted - CEP remains valid\|27/01/2021
685	Povidone, K17	BOAI NKY MEDICAL HOLDINGS LTD. Jiaozuo CN	100051122;100089488	CEP 2024-236 - Rev 00	2025/07/22	Valid	22/07/2030	Chemical	2025/07/23	New application\|CEP granted\|23/07/2025
2359	Dorzolamide hydrochloride	CURIA SPAIN S.A.U. Boecillo ES	100011649;100019586	CEP 2010-115 - Rev 04	2025/07/22	Valid		Chemical	2025/07/23	Minor revision\|CEP granted\|23/07/2025; Minor revision\|CEP granted\|15/11/2021; Notification\|CEP granted\|24/08/2021; Minor revision\|CEP granted\|04/12/2020
2736	Imatinib mesilate	CDYMAX (INDIA) PHARMA PRIVATE LIMITED Bangalore IN	100017076;100025868	CEP 2018-262 - Rev 02	2025/07/22	Valid		Chemical	2025/07/23	Renewal\|CEP granted\|23/07/2025; Minor revision\|CEP granted\|24/10/2022; Major revision\|Rejected\|18/08/2022
2541	Quetiapine Fumarate	COHANCE LIFESCIENCES LIMITED Mumbai IN	100011755;100090273	CEP 2017-175 - Rev 02	2025/07/22	Valid		Chemical	2025/07/23	Minor revision\|CEP granted\|23/07/2025; Notification\|CEP granted\|09/07/2024; Minor revision\|Accepted - CEP remains valid\|25/10/2023; Minor revision\|Accepted - CEP remains valid\|22/02/2024; Renewal\|CEP granted\|20/06/2023; Minor revision\|CEP granted\|13/09/2022; Notification\|CEP granted\|12/02/2021
260	Amoxicillin trihydrate	SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD Datong CN	100033465;100052362	CEP 2019-244 - Rev 03	2025/07/22	Valid		Chemical	2025/07/23	Renewal\|CEP granted\|23/07/2025; Minor revision\|CEP granted\|18/12/2023; Minor revision\|CEP granted\|29/09/2021
.	Bovine Calf Serum, Defined, Supplemented, Cosmic	HYCLONE LABORATORIES LLC. Logan US	100012797;100022115	CEP 2000-080 - Rev 06	2025/07/22	Valid		TSE	2025/12/11	Major revision\|Accepted - CEP remains valid\|11/12/2025; Major revision\|Rejected\|17/10/2025; Notification\|CEP granted\|23/07/2025; Notification\|Accepted - CEP remains valid\|10/05/2022; Notification\|Rejected\|25/03/2022; Notification\|CEP granted\|24/06/2020
2932	Rivaroxaban	LEE PHARMA LIMITED Hyderabad IN	100014849;100042625	CEP 2022-339 - Rev 01	2025/07/21	Valid	06/11/2029	Chemical	2025/07/21	Minor revision\|CEP granted\|21/07/2025; New application\|CEP granted\|06/11/2024
575	Cholecalciferol concentrate (oily form), 1 000 000 IU/g, with all-rac-α-tocopherol, in Triglycerides, medium-chain	DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH	100053293;100094111	CEP 2021-055 - Rev 01	2025/07/21	Valid	16/11/2027	Chemical and TSE	2025/07/21	Notification\|CEP granted\|21/07/2025; New application\|CEP granted\|16/11/2022
1627	Turpentine oil, Rectified	FREY + LAU GMBH Henstedt-Ulzburg DE	100017333;100026131	CEP 2019-216 - Rev 02	2025/07/21	Valid		Herbal	2025/07/21	Renewal\|CEP granted\|21/07/2025; Minor revision\|Rejected\|14/03/2025; Major revision\|CEP granted\|21/03/2023; Notification\|Accepted - CEP remains valid\|13/08/2021
1250	Omega-3-acid ethyl esters 90, with 0.03% alpha-tocopherol	KINOMEGA BIOPHARM INC. Deyang City CN	100051579;100090542	CEP 2025-216 - Rev 00	2025/07/21	Valid	21/07/2030	Chemical	2025/07/21	New application\|CEP granted\|21/07/2025
72	Cholecalciferol	DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH	100053293;100094111	CEP 2009-050 - Rev 04	2025/07/21	Valid		Chemical and TSE	2025/07/21	Notification\|CEP granted\|21/07/2025; Minor revision\|CEP granted\|06/12/2024; Minor revision\|CEP granted\|20/03/2024
1829	Horse-chestnut dry extract, standardised, DER 5-7:1	BERNETT SRL Milano IT	100021863;100031972	CEP 2019-055 - Rev 01	2025/07/21	Valid		Herbal	2025/07/21	Renewal\|CEP granted\|21/07/2025; Notification\|Accepted - CEP remains valid\|15/05/2024; Monograph revision\|Accepted - CEP remains valid\|28/03/2024; Notification\|Accepted - CEP remains valid\|06/08/2021
1324	Flecainide acetate	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2017-183 - Rev 02	2025/07/21	Valid		Chemical	2025/07/21	Minor revision\|CEP granted\|21/07/2025; Notification\|CEP granted\|13/12/2023; Minor revision\|Accepted - CEP remains valid\|20/11/2023; Renewal\|CEP granted\|20/04/2023; Minor revision\|CEP granted\|15/09/2020
2600	Olmesartan medoxomil, Process-II, BS-BS	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2025-177 - Rev 00	2025/07/21	Valid	21/07/2030	Chemical	2025/07/21	New application\|CEP granted\|21/07/2025
58	Triamterene	DIPHARMA FRANCIS S.R.L. Baranzate IT	100014675;100030401	CEP 2024-567 - Rev 00	2025/07/21	Valid	21/07/2030	Chemical	2025/07/21	New application\|CEP granted\|21/07/2025
3014	Rotigotine, Polymorph II	OLON S.P.A. Rodano IT	100012085;100019537	CEP 2022-040 - Rev 01	2025/07/21	Valid	10/06/2029	Chemical	2025/07/21	Minor revision\|CEP granted\|21/07/2025; New application\|CEP granted\|10/06/2024

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)	-