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
942	Omeprazole, Form-B	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2015-011 - Rev 03	2025/05/14	Valid		Chemical	2025/05/14	Notification\|CEP granted\|14/05/2025; Notification\|Accepted - CEP remains valid\|15/04/2024; Administrative procedure\|CEP granted\|05/04/2024; Minor revision\|CEP granted\|08/11/2023; Renewal\|CEP granted\|08/09/2022
2736	Imatinib mesilate, FORM-β, ES Process	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2025-106 - Rev 00	2025/05/14	Valid	14/05/2030	Chemical	2025/05/14	New application\|CEP granted\|14/05/2025
1310	Dihydralazine sulfate, hydrated	AMOLI ORGANICS LLP Mumbai IN	100054134;100095785	CEP 2015-027 - Rev 01	2025/05/14	Valid		Chemical	2025/05/14	Notification\|CEP granted\|14/05/2025; Renewal\|CEP granted\|30/06/2021
1292	Amphotericin B, Process I	ZHEJIANG TIANTAI PHARMACEUTICAL CO., LTD. Taizhou City CN	100011852;100018559	CEP 2023-150 - Rev 01	2025/05/14	Valid	17/06/2029	Chemical	2025/05/14	Minor revision\|CEP granted\|14/05/2025; New application\|CEP granted\|17/06/2024
653	Baclofen	PIRAMAL PHARMA LIMITED Digwal Village IN	100036948;100058375	CEP 2016-313 - Rev 01	2025/05/14	Valid		Chemical	2025/05/14	Monograph revision\|CEP granted\|14/05/2025; Renewal\|CEP granted\|04/07/2023; Notification\|CEP granted\|07/01/2022; Notification\|CEP granted\|20/11/2020
2641	Dutasteride	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2014-306 - Rev 02	2025/05/13	Valid		Chemical	2025/05/13	Minor revision\|CEP granted\|13/05/2025; Notification\|CEP granted\|16/11/2023; Minor revision\|Accepted - CEP remains valid\|11/04/2022; Minor revision\|Accepted - CEP remains valid\|22/02/2021; Renewal\|CEP granted\|24/11/2020; Minor revision\|CEP granted\|28/04/2020
2015	Ebastine	MICRO LABS LIMITED Bengaluru IN	100017819;100077269	CEP 2009-106 - Rev 04	2025/05/13	Valid		Chemical	2025/05/13	Minor revision\|CEP granted\|13/05/2025; Minor revision\|CEP granted\|13/07/2023
2733	Escitalopram oxalate, Process I	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2016-306 - Rev 01	2025/05/13	Valid		Chemical	2025/05/13	Minor revision\|CEP granted\|13/05/2025; Renewal\|CEP granted\|23/05/2023; Minor revision\|CEP granted\|28/10/2020
2778	Sitagliptin phosphate monohydrate	MOREPEN LABORATORIES LIMITED Baddi IN	100017843;100026642	CEP 2019-040 - Rev 01	2025/05/13	Valid		Chemical	2025/05/13	Renewal\|CEP granted\|13/05/2025
1710	Bisoprolol fumarate	MEDILUX LABORATORIES PRIVATE LIMITED Pithampur IN	100023732;100032901	CEP 2018-209 - Rev 01	2025/05/13	Valid		Chemical	2025/05/13	Renewal\|CEP granted\|13/05/2025
2740	Sodium selenite	RETORTE GMBH SELENIUM CHEMICALS & METALS Röthenbach DE	100026545;100042398	CEP 2018-129 - Rev 02	2025/05/13	Valid		Chemical	2025/05/13	Minor revision\|CEP granted\|13/05/2025; Renewal\|CEP granted\|15/02/2024
2782	Vardenafil hydrochloride trihydrate	SMS PHARMACEUTICALS LIMITED Hyderabad IN	100011780;100061058	CEP 2018-202 - Rev 02	2025/05/13	Valid		Chemical	2025/05/13	Renewal\|CEP granted\|13/05/2025; Minor revision\|CEP granted\|04/04/2024
.	Collagen Peptide	SICHUAN RAYBO BIOTECHNOLOGY CO. LTD. Guanghan CN	100054197;100095911	CEP 2019-322 - Rev 01	2025/05/13	Valid		TSE	2025/05/13	Renewal\|CEP granted\|13/05/2025
2675	Irinotecan hydrochloride trihydrate	COHANCE LIFESCIENCES LIMITED Mumbai IN	100011755;100090273	CEP 2023-338 - Rev 00	2025/05/13	Valid	13/05/2030	Chemical	2025/05/13	New application\|CEP granted\|13/05/2025
2593	Docetaxel	CHONGQING SINTAHO PHARMACEUTICAL CO., LTD. Maliuzui CN	100041836;100068984	CEP 2022-295 - Rev 01	2025/05/13	Valid	28/09/2028	Chemical	2025/05/13	Minor revision\|CEP granted\|13/05/2025; New application\|CEP granted\|28/09/2023
2422	Oseltamivir phosphate, Form-A	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2018-046 - Rev 02	2025/05/09	Valid		Chemical	2025/05/09	Renewal\|CEP granted\|09/05/2025; Minor revision\|CEP granted\|25/09/2023; Minor revision\|Accepted - CEP remains valid\|05/01/2022
2577	Oxcarbazepine	SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN	100044578;100073706	CEP 2022-458 - Rev 00	2025/05/09	Valid	09/05/2030	Chemical	2025/05/09	New application\|CEP granted\|09/05/2025
1681	Tramadol hydrochloride	SUPRIYA LIFESCIENCE LIMITED Mumbai IN	100015796;100024574	CEP 2023-203 - Rev 00	2025/05/09	Valid	09/05/2030	Chemical	2025/05/09	New application\|CEP granted\|09/05/2025
2857	Trazodone hydrochloride	BAJAJ HEALTHCARE LIMITED Thane IN	100021782;100061986	CEP 2023-228 - Rev 00	2025/05/09	Valid	09/05/2030	Chemical	2025/05/09	New application\|CEP granted\|09/05/2025
1717	Desogestrel	NEWCHEM S.p.A. Milano IT	100017847;100080332	CEP 2023-246 - Rev 00	2025/05/09	Valid	09/05/2030	Chemical	2025/05/09	New application\|CEP granted\|09/05/2025

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)	-