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
1431	Haloperidol decanoate	MANKIND PHARMA LIMITED New Delhi IN	100040218;100065486	CEP 2020-080 - Rev 03	2025/06/24	Valid	20/05/2027	Chemical	2025/06/24	Administrative procedure\|CEP granted\|24/06/2025; Notification\|CEP granted\|06/06/2025; Minor revision\|Accepted - CEP remains valid\|08/11/2024; Major revision\|CEP granted\|30/08/2024; New application\|CEP granted\|20/05/2022
901	Fenoterol hydrobromide	VAMSI LABS LIMITED Solapur IN	100014747;100096958	CEP 2020-160 - Rev 03	2025/06/24	Valid	08/03/2027	Chemical	2025/06/24	Notification\|CEP granted\|24/06/2025; Minor revision\|CEP granted\|14/11/2023; Notification\|Rejected\|21/09/2023; Notification\|CEP granted\|28/07/2022; New application\|CEP granted\|08/03/2022
1750	Fluticasone propionate, Micronised	VAMSI LABS LIMITED Solapur IN	100014747;100096958	CEP 2020-078 - Rev 03	2025/06/24	Valid	29/10/2026	Chemical	2025/06/24	Notification\|CEP granted\|24/06/2025; Minor revision\|CEP granted\|11/12/2023; Notification\|CEP granted\|28/07/2022; New application\|CEP granted\|29/10/2021
2191	Atorvastatin calcium, Trihydrate	MANKIND PHARMA LIMITED New Delhi IN	100040218;100065486	CEP 2022-262 - Rev 02	2025/06/24	Valid	16/02/2029	Chemical	2026/02/18	Major revision\|Rejected\|18/02/2026; Administrative procedure\|CEP granted\|24/06/2025; Notification\|CEP granted\|06/06/2025; New application\|CEP granted\|16/02/2024
2931	Sorafenib tosilate, Form-I	MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN	100011732;100023530	CEP 2023-185 - Rev 01	2025/06/24	Valid	29/10/2029	Chemical	2025/06/24	Monograph revision\|CEP granted\|24/06/2025; New application\|CEP granted\|29/10/2024
919	Ipratropium bromide, Micronised	VAMSI LABS LIMITED Solapur IN	100014747;100096958	CEP 2023-137 - Rev 01	2025/06/24	Valid	05/11/2029	Chemical	2025/06/24	Notification\|CEP granted\|24/06/2025; New application\|CEP granted\|05/11/2024
1250	Omega-3-acid ethyl esters 90, Code K85EE - containing alpha tocopherol as antioxidant	BASF AS Oslo NO	100003052;100032709	CEP 2008-132 - Rev 05	2025/06/23	Valid		Chemical	2025/06/23	Minor revision\|CEP granted\|23/06/2025; Notification\|Accepted - CEP remains valid\|25/07/2023; Notification\|CEP granted\|21/01/2020
2541	Quetiapine Fumarate	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2017-210 - Rev 05	2025/06/23	Valid		Chemical	2025/06/23	Minor revision\|CEP granted\|23/06/2025; Renewal\|CEP granted\|17/04/2024; Minor revision\|CEP granted\|19/12/2023; Minor revision\|CEP granted\|15/11/2022; Minor revision\|CEP granted\|10/01/2022; Minor revision\|Accepted - CEP remains valid\|06/11/2020
2779	Solifenacin succinate	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2016-059 - Rev 02	2025/06/23	Valid		Chemical	2025/06/23	Minor revision\|CEP granted\|23/06/2025; Notification\|CEP granted\|16/01/2024; Renewal\|CEP granted\|27/09/2022
1250	Omega-3-acid ethyl esters 90, Code 03 K85EE - containing alpha tocopherol as antioxidant	BASF AS Oslo NO	100003052;100032709	CEP 2008-330 - Rev 05	2025/06/23	Valid		Chemical	2025/06/23	Minor revision\|CEP granted\|23/06/2025; Notification\|Accepted - CEP remains valid\|25/07/2023; Notification\|CEP granted\|21/01/2020
1563	Simvastatin, BHA, Process II	SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN	100023303;100032437	CEP 2025-108 - Rev 00	2025/06/23	Valid	23/06/2030	Chemical	2025/06/23	New application\|CEP granted\|23/06/2025
2779	Solifenacin succinate	ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shaoxing CN	100022562;100093113	CEP 2021-166 - Rev 02	2025/06/23	Valid	12/01/2027	Chemical	2025/06/23	Minor revision\|CEP granted\|23/06/2025; Notification\|Accepted - CEP remains valid\|05/06/2024; Major revision\|CEP granted\|23/03/2023; New application\|CEP granted\|12/01/2022
1437	Hexylresorcinol	KUMAR ORGANIC PRODUCTS LIMITED Bangalore IN	100023755;100042848	CEP 2023-240 - Rev 00	2025/06/23	Valid	23/06/2030	Chemical	2025/06/23	New application\|CEP granted\|23/06/2025
2931	Sorafenib tosilate	BDR LIFESCIENCES PRIVATE LIMITED Luna Village IN	100034093;100053921	CEP 2022-478 - Rev 01	2025/06/23	Valid	06/11/2029	Chemical	2025/06/23	Monograph revision\|CEP granted\|23/06/2025; New application\|CEP granted\|06/11/2024
1647	Lactobionic acid	GLOBAL CALCIUM PRIVATE LIMITED Hosur IN	100020125;100028859	CEP 2018-164 - Rev 01	2025/06/20	Valid		Chemical	2025/06/20	Renewal\|CEP granted\|20/06/2025
1092	Cyclizine Hydrochloride	MICRO LABS LIMITED Bengaluru IN	100017819;100077269	CEP 2010-355 - Rev 04	2025/06/20	Valid		Chemical	2025/06/20	Minor revision\|CEP granted\|20/06/2025; Minor revision\|Accepted - CEP remains valid\|07/12/2020
884	Carbimazole	CURIA FRANCE S.A.S. Bon-Encontre FR	100040782;100067084	CEP 2019-078 - Rev 02	2025/06/20	Valid		Chemical	2026/04/01	Notification\|Accepted - CEP remains valid\|01/04/2026; Renewal\|CEP granted\|20/06/2025; Minor revision\|Accepted - CEP remains valid\|25/04/2024; Minor revision\|Accepted - CEP remains valid\|28/04/2023; Minor revision\|CEP granted\|26/08/2021
2244	Tacrolimus monohydrate	BIOCON LIMITED Bengaluru IN	100011487;100018595	CEP 2017-257 - Rev 02	2025/06/20	Valid		Chemical	2025/06/20	Minor revision\|CEP granted\|20/06/2025; Notification\|Accepted - CEP remains valid\|04/03/2024; Minor revision\|CEP granted\|29/11/2023; Renewal\|CEP granted\|15/03/2023; Major revision\|CEP granted\|12/12/2022; Major revision\|Rejected\|20/10/2022; Minor revision\|Accepted - CEP remains valid\|10/03/2022; Minor revision\|Accepted - CEP remains valid\|09/06/2021; Minor revision\|CEP granted\|23/09/2020
1352	Omega-3-acid triglycerides, Containing alpha tocopherol as antioxidant	BASF AS Oslo NO	100003052;100032709	CEP 2017-298 - Rev 05	2025/06/20	Valid		Chemical	2025/06/20	Minor revision\|CEP granted\|20/06/2025; Renewal\|CEP granted\|21/08/2024; Notification\|Accepted - CEP remains valid\|25/07/2023; Monograph revision\|Accepted - CEP remains valid\|06/01/2021; Minor revision\|CEP granted\|18/05/2020; Notification\|CEP granted\|28/01/2020
330	Gelatin, Alkaline hide gelatin	SHANDONG HENGXIN BIOTECH CO., LTD. Binzhou City CN	100054241;100096001	CEP 2020-191 - Rev 01	2025/06/20	Valid		TSE	2025/06/20	Renewal\|CEP granted\|20/06/2025; New application\|CEP granted\|30/11/2020

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)	-