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
614	Glycine	AMINO GMBH Frellstedt DE	100011599;100021107	CEP 2013-179 - Rev 02	2026/01/27	Valid		Chemical	2026/01/27	Minor revision\|CEP granted\|27/01/2026; Notification\|Accepted - CEP remains valid\|13/09/2023; Minor revision\|CEP granted\|08/07/2022; Renewal\|CEP granted\|31/05/2021
653	Baclofen	COHANCE LIFESCIENCES LIMITED Mumbai IN	100011755;100090273	CEP 2018-280 - Rev 03	2026/01/27	Valid	17/06/2026	Chemical	2026/01/27	Monograph revision\|CEP granted\|27/01/2026; Minor revision\|CEP granted\|22/01/2025; Notification\|CEP granted\|15/12/2022
2778	Sitagliptin phosphate monohydrate	ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN	100012174;100018701	CEP 2020-037 - Rev 02	2026/01/27	Valid	13/07/2026	Chemical	2026/01/27	Minor revision\|CEP granted\|27/01/2026; Notification\|Accepted - CEP remains valid\|06/08/2025; Minor revision\|CEP granted\|20/09/2023; New application\|CEP granted\|13/07/2021
645	Tobramycin, EHS Optimized Process	CHONGQING DAXIN PHARMACEUTICAL CO., LTD. Shuitu Town CN	100011996;100039007	CEP 2019-036 - Rev 02	2026/01/27	Valid		Chemical	2026/01/27	Monograph revision\|CEP granted\|27/01/2026; Renewal\|CEP granted\|31/07/2024
922	Ketoprofen	ANLON HEALTHCARE LIMITED Gondal IN	100049220;100083386	CEP 2023-344 - Rev 01	2026/01/27	Valid	31/01/2030	Chemical	2026/01/27	Minor revision\|CEP granted\|27/01/2026; New application\|CEP granted\|31/01/2025
1363	Prilocaine Hydrochloride	SWATI SPENTOSE PRIVATE LIMITED Mumbai IN	100021605;100052219	CEP 2021-035 - Rev 01	2026/01/27	Valid	14/04/2030	Chemical	2026/01/27	Minor revision\|CEP granted\|27/01/2026; New application\|CEP granted\|14/04/2025
2993	Nilotinib hydrochloride monohydrate, Form-B	DR. REDDY'S LABORATORIES LIMITED Hyderabad IN	100003991;100000217	CEP 2023-226 - Rev 00	2026/01/26	Valid	26/01/2031	Chemical	2026/01/26	New application\|CEP granted\|26/01/2026
2423	Valsartan	ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN	100006039;100002980	CEP 2010-065 - Rev 09	2026/01/26	Valid		Chemical	2026/01/26	Minor revision\|CEP granted\|26/01/2026; Minor revision\|CEP granted\|27/09/2024; Minor revision\|CEP granted\|18/10/2023; Minor revision\|CEP granted\|06/10/2020
2631	Rosuvastatin calcium, Amorphous	SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN	100008538;100018201	CEP 2017-069 - Rev 05	2026/01/26	Valid		Chemical	2026/01/26	Notification\|CEP granted\|26/01/2026; Renewal\|CEP granted\|28/03/2024; Minor revision\|Accepted - CEP remains valid\|31/01/2022; Minor revision\|CEP granted\|06/07/2021; Monograph revision\|CEP granted\|05/05/2020; Notification\|CEP granted\|29/01/2020
2372	Esomeprazole magnesium trihydrate	METROCHEM API PRIVATE LIMITED Hyderabad IN	100045158;100074519	CEP 2020-386 - Rev 03	2026/01/26	Valid	24/05/2027	Chemical	2026/01/26	Minor revision\|CEP granted\|26/01/2026; Minor revision\|CEP granted\|26/08/2024; Notification\|CEP granted\|14/06/2024; New application\|CEP granted\|24/05/2022
2993	Nilotinib hydrochloride monohydrate	RAVI BIOLIFE PRIVATE LIMITED Mumbai IN	100048404;100086771	CEP 2022-425 - Rev 01	2026/01/26	Valid	19/04/2029	Chemical	2026/01/26	Minor revision\|CEP granted\|26/01/2026; New application\|CEP granted\|19/04/2024
1275	Ursodeoxycholic acid	SUZHOU TIANLU BIO-PHARMACEUTICAL CO. LTD. Suzhou CN	100018634;100027427	CEP 2023-317 - Rev 02	2026/01/26	Valid	07/02/2030	Chemical	2026/01/26	Monograph revision\|CEP granted\|26/01/2026; Administrative procedure\|CEP granted\|03/03/2025; New application\|CEP granted\|07/02/2025
2888	Rupatadine fumarate	MOREPEN LABORATORIES LIMITED Baddi IN	100017843;100026642	CEP 2025-532 - Rev 00	2026/01/26	Valid	26/01/2031	Chemical	2026/01/26	New application\|CEP granted\|26/01/2026
2541	Quetiapine Fumarate	ALKEM LABORATORIES LIMITED Mumbai IN	100005554;100010367	CEP 2025-036 - Rev 00	2026/01/23	Valid	23/01/2031	Chemical	2026/01/23	New application\|CEP granted\|23/01/2026
3137	Dapagliflozin propylene glycol monohydrate, SC-3 crystalline form, Micronised and Non-Micronised	MSN LABORATORIES PRIVATE LIMITED Sangareddy IN	100011732;100018657	CEP 2025-239 - Rev 00	2026/01/23	Valid	23/01/2031	Chemical	2026/01/23	New application\|CEP granted\|23/01/2026
2600	Olmesartan medoxomil, Process-II, Micronised, non-micronised	CPL PHARMACEUTICALS PRIVATE LIMITED Ahmedabad IN	100048075;100079517	CEP 2025-511 - Rev 00	2026/01/23	Valid	23/01/2031	Chemical	2026/01/23	New application\|CEP granted\|23/01/2026
1442	Leuprorelin, Process F	POLYPEPTIDE LABORATORIES (SWEDEN) AB Limhamn SE	100011740;100020303	CEP 2011-321 - Rev 03	2026/01/23	Valid		Chemical	2026/01/23	Minor revision\|CEP granted\|23/01/2026; Minor revision\|Accepted - CEP remains valid\|02/06/2025; Notification\|Rejected\|07/05/2025; Major revision\|Accepted - CEP remains valid\|12/07/2024; Notification\|Rejected\|26/04/2024; Minor revision\|Accepted - CEP remains valid\|20/09/2023; Minor revision\|CEP granted\|26/01/2023; Minor revision\|CEP granted\|23/09/2020
2362	Rifaximin, Micronised, non-micronised	LUPIN LIMITED Mumbai IN	100004130;100015605	CEP 2020-175 - Rev 01	2026/01/23	Valid	07/12/2027	Chemical and TSE	2026/01/23	Major revision\|CEP granted\|23/01/2026; Minor revision\|Accepted - CEP remains valid\|21/06/2023; New application\|CEP granted\|07/12/2022
2773	Memantine hydrochloride	ZHEJIANG SUPOR PHARMACEUTICALS CO., LTD. Shaoxing CN	100022886;100031604	CEP 2025-311 - Rev 00	2026/01/23	Valid	23/01/2031	Chemical	2026/01/23	New application\|CEP granted\|23/01/2026
3095	Dabigatran etexilate mesilate	METROCHEM API PRIVATE LIMITED Hyderabad IN	100045158;100074519	CEP 2024-130 - Rev 00	2026/01/22	Valid	22/01/2031	Chemical	2026/01/22	New application\|CEP granted\|22/01/2026

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)	-