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
2423	Valsartan	IPCA LABORATORIES LIMITED Mumbai IN	100011685;100018680	CEP 2010-100 - Rev 06	2025/09/22	Valid		Chemical	2025/09/22	Minor revision\|CEP granted\|22/09/2025; Minor revision\|CEP granted\|18/11/2022; Minor revision\|Accepted - CEP remains valid\|15/06/2022; Minor revision\|CEP granted\|01/12/2020; Minor revision\|Accepted - CEP remains valid\|19/05/2020
1442	Leuprorelin	CHEMI S.P.A. Patrica IT	100000347;100009242	CEP 2008-115 - Rev 05	2025/09/22	Valid		Chemical	2025/09/22	Minor revision\|CEP granted\|22/09/2025; Minor revision\|CEP granted\|10/03/2022; Notification\|Rejected\|30/11/2021; Minor revision\|Accepted - CEP remains valid\|28/05/2020
533	Triamcinolone acetonide	AVIK PHARMACEUTICAL LIMITED Vapi IN	100023327;100041968	CEP 2018-231 - Rev 01	2025/09/22	Valid		Chemical	2025/09/22	Renewal\|CEP granted\|22/09/2025; Notification\|Accepted - CEP remains valid\|17/06/2022
687	Salbutamol sulfate, Micronised	MELODY HEALTHCARE PRIVATE LIMITED Mumbai IN	100014822;100073679	CEP 2020-063 - Rev 03	2025/09/22	Valid		Chemical	2025/09/22	Renewal\|CEP granted\|22/09/2025; Monograph revision\|CEP granted\|25/03/2024; Minor revision\|CEP granted\|23/03/2022; New application\|CEP granted\|21/10/2020
2333	Fluvastatin sodium, Crystalline-2	BIOCON LIMITED Bengaluru IN	100011487;100018595	CEP 2022-130 - Rev 02	2025/09/22	Valid	15/06/2027	Chemical	2025/09/22	Minor revision\|CEP granted\|22/09/2025; Administrative procedure\|CEP granted\|23/06/2022; New application\|CEP granted\|15/06/2022
1300	Cefuroxime axetil, Amorphous	TITAN PHARMACEUTICAL CO., LTD. (GUANGDONG) Heyuan City CN	100024682;100033865	CEP 2017-034 - Rev 01	2025/09/22	Valid		Chemical	2025/09/22	Minor revision\|CEP granted\|22/09/2025; Renewal\|CEP granted\|20/04/2023; Minor revision\|CEP granted\|02/09/2021; Minor revision\|CEP granted\|23/04/2021
2333	Fluvastatin sodium, Amorphous-2	BIOCON LIMITED Bengaluru IN	100011487;100018595	CEP 2022-139 - Rev 02	2025/09/22	Valid	22/07/2027	Chemical	2025/09/22	Minor revision\|CEP granted\|22/09/2025; Administrative procedure\|CEP granted\|08/08/2022; New application\|CEP granted\|22/07/2022
798	Fusidic acid, Process B	FUJIAN COMHONY BIOTECHNOLOGY CO., LTD. Fuqing CN	100043888;100072481	CEP 2022-330 - Rev 02	2025/09/22	Valid	28/04/2028	Chemical	2025/09/22	Minor revision\|CEP granted\|22/09/2025; Minor revision\|CEP granted\|15/10/2024; New application\|CEP granted\|28/04/2023
848	Sodium fusidate, Process B	FUJIAN COMHONY BIOTECHNOLOGY CO., LTD. Fuqing CN	100043888;100072481	CEP 2022-369 - Rev 02	2025/09/22	Valid	28/04/2028	Chemical	2025/09/22	Minor revision\|CEP granted\|22/09/2025; Minor revision\|CEP granted\|04/11/2024; New application\|CEP granted\|28/04/2023
2191	Atorvastatin calcium, Process 4, polymorphic form-I	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2024-238 - Rev 02	2025/09/22	Valid	04/10/2029	Chemical	2025/09/22	Major revision\|CEP granted\|22/09/2025; Notification\|CEP granted\|26/05/2025; New application\|CEP granted\|07/10/2024
1472	Sodium hyaluronate, Intrinsic viscosity 1.55 m3/kg, by fermentation, for parenteral administration including intra-articular administration and for intra-ocular use	AMHWA BIOPHARM CO., LTD. Binzhou CN	100054851;100097324	CEP 2018-285 - Rev 02	2025/09/19	Valid		Chemical	2025/09/19	Renewal\|CEP granted\|19/09/2025; Notification\|CEP granted\|21/06/2022
2465	Irbesartan, Process II	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN	100051463;100098142	CEP 2021-100 - Rev 04	2025/09/19	Valid	27/09/2026	Chemical	2025/09/19	Notification\|CEP granted\|19/09/2025; Minor revision\|Accepted - CEP remains valid\|16/12/2024; Notification\|CEP granted\|19/07/2024; Minor revision\|CEP granted\|28/04/2023; Minor revision\|CEP granted\|12/07/2022; New application\|CEP granted\|27/09/2021
931	Metformin Hydrochloride	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2004-088 - Rev 10	2025/09/18	Valid		Chemical	2025/09/18	Minor revision\|CEP granted\|18/09/2025; Minor revision\|CEP granted\|21/11/2024; Notification\|CEP granted\|13/12/2023; Minor revision\|CEP granted\|02/03/2021
2018	Paroxetine hydrochloride hemihydrate	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2006-206 - Rev 05	2025/09/18	Valid		Chemical	2025/09/18	Minor revision\|CEP granted\|18/09/2025; Minor revision\|Accepted - CEP remains valid\|15/10/2024; Notification\|CEP granted\|13/12/2023; Minor revision\|CEP granted\|26/01/2023; Minor revision\|Accepted - CEP remains valid\|13/07/2022; Notification\|Accepted - CEP remains valid\|06/11/2020
2617	Aripiprazole	ZAKŁADY FARMACEUTYCZNE POLPHARMA S.A. Starogard Gdański PL	100000470;100001572	CEP 2013-230 - Rev 03	2025/09/18	Valid		Chemical	2025/09/18	Minor revision\|CEP granted\|18/09/2025; Minor revision\|CEP granted\|17/03/2023; Monograph revision\|CEP granted\|16/07/2021; Renewal\|CEP granted\|11/06/2020
1287	Alfuzosin hydrochloride	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2007-080 - Rev 04	2025/09/18	Valid		Chemical	2025/09/18	Minor revision\|CEP granted\|18/09/2025; Minor revision\|Accepted - CEP remains valid\|29/08/2024; Notification\|CEP granted\|16/11/2023; Notification\|Accepted - CEP remains valid\|15/07/2021; Minor revision\|Accepted - CEP remains valid\|08/09/2020
2409	Diacerein	AMI LIFESCIENCES PRIVATE LIMITED Vadodara IN	100021822;100030527	CEP 2015-173 - Rev 04	2025/09/18	Valid		Chemical	2025/10/17	Minor revision\|Accepted - CEP remains valid\|17/10/2025; Minor revision\|CEP granted\|18/09/2025; Minor revision\|CEP granted\|03/12/2024; Minor revision\|Accepted - CEP remains valid\|28/11/2022; Administrative procedure\|CEP granted\|04/04/2022; Notification\|CEP granted\|18/01/2022; Renewal\|CEP granted\|17/11/2021
2751	Valaciclovir hydrochloride hydrate	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2013-318 - Rev 03	2025/09/18	Valid		Chemical	2025/09/18	Minor revision\|CEP granted\|18/09/2025; Notification\|CEP granted\|02/02/2024; Major revision\|CEP granted\|22/08/2022
2631	Rosuvastatin calcium	SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN	100023303;100032437	CEP 2019-309 - Rev 03	2025/09/18	Valid		Chemical	2025/09/18	Renewal\|CEP granted\|18/09/2025; Minor revision\|Accepted - CEP remains valid\|14/03/2024; Notification\|CEP granted\|26/01/2024; Minor revision\|CEP granted\|26/10/2023; Minor revision\|Accepted - CEP remains valid\|03/10/2022
2531	Clopidogrel hydrogen sulfate, Form-II	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN	100051463;100098142	CEP 2018-220 - Rev 05	2025/09/18	Valid		Chemical	2025/09/18	Notification\|CEP granted\|18/09/2025; Renewal\|CEP granted\|17/01/2025; Notification\|CEP granted\|22/07/2024; Notification\|CEP granted\|01/09/2021; Minor revision\|CEP granted\|15/07/2021

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)	-