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
2173	Gabapentin	ZHEJIANG BAMBOO PHARMACEUTICALS CO.,LTD. Shaoxing CN	100047946;100079294	CEP 2023-027 - Rev 02	2025/04/25	Valid	04/01/2029	Chemical	2025/04/25	Minor revision\|CEP granted\|25/04/2025; Minor revision\|CEP granted\|11/03/2024; New application\|CEP granted\|04/01/2024
1513	Etofenamate	DUKE CHEM, S.A.U. Olérdola ES	100022432;100031112	CEP 2014-154 - Rev 02	2025/04/25	Valid		Chemical	2025/04/25	Minor revision\|CEP granted\|25/04/2025; Minor revision\|CEP granted\|27/02/2024; Renewal\|CEP granted\|02/10/2020
916	Hydroxyzine hydrochloride	IPCA LABORATORIES LIMITED Mumbai IN	100011685;100018680	CEP 2010-076 - Rev 04	2025/04/25	Valid		Chemical	2025/04/25	Minor revision\|CEP granted\|25/04/2025; Minor revision\|CEP granted\|11/09/2024; Notification\|Accepted - CEP remains valid\|23/06/2023; Minor revision\|CEP granted\|03/08/2021
2888	Rupatadine fumarate, Micronised and Non-micronised	CADILA PHARMACEUTICALS LIMITED Ankleshwar IN	100003616;100000498	CEP 2018-161 - Rev 03	2025/04/25	Valid		Chemical	2025/04/25	Renewal\|CEP granted\|25/04/2025; Minor revision\|CEP granted\|25/01/2024; Minor revision\|Accepted - CEP remains valid\|01/08/2022; Minor revision\|CEP granted\|18/12/2020
2333	Fluvastatin sodium, Amorphous	BIOCON LIMITED Bengaluru IN	100011487;100018595	CEP 2016-075 - Rev 01	2025/04/25	Valid		Chemical	2025/04/25	Minor revision\|CEP granted\|25/04/2025; Renewal\|CEP granted\|14/10/2022; Minor revision\|Rejected\|25/01/2022; Major revision\|Rejected\|14/09/2021
1750	Fluticasone propionate, Micronised	GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED London GB	100005535;100093170	CEP 2018-229 - Rev 03	2025/04/25	Valid		Chemical	2025/04/25	Notification\|CEP granted\|25/04/2025; Renewal\|CEP granted\|16/12/2024; Monograph revision\|Accepted - CEP remains valid\|12/07/2021; Notification\|CEP granted\|07/12/2020
855	Praziquantel	SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN	100032307;100053537	CEP 2021-162 - Rev 00	2025/04/25	Valid	25/04/2030	Chemical	2025/04/25	New application\|CEP granted\|25/04/2025
823	Etoposide	MAC CHEM PRODUCTS (INDIA) PRIVATE LIMITED Mumbai IN	100023737;100061579	CEP 2020-074 - Rev 02	2025/04/25	Valid	25/07/2027	Chemical	2025/04/25	Minor revision\|CEP granted\|25/04/2025; Administrative procedure\|CEP granted\|30/04/2024; New application\|CEP granted\|25/07/2022
391	Furosemide	MANGALAM DRUGS & ORGANICS LTD. Mumbai IN	100012477;100021137	CEP 2019-063 - Rev 02	2025/04/25	Valid	07/09/2026	Chemical	2025/04/25	Notification\|CEP granted\|25/04/2025; Major revision\|CEP granted\|02/03/2023
2541	Quetiapine Fumarate	ZHEJIANG SYNCOZYMES BIO-PHARMACEUTICAL CO. LTD. Shaoxing CN	100049378;100084024	CEP 2024-190 - Rev 01	2025/04/25	Valid	08/04/2030	Chemical	2025/04/25	Administrative procedure\|CEP granted\|25/04/2025; New application\|CEP granted\|08/04/2025
2358	Teicoplanin, Changhai site	ZHEJIANG MEDICINE CO., LTD. Shaoxing CN	100022357;100084942	CEP 2022-436 - Rev 01	2025/04/25	Valid	10/02/2028	Chemical	2025/04/25	Minor revision\|CEP granted\|25/04/2025; New application\|CEP granted\|10/02/2023
2932	Rivaroxaban	HIKAL LIMITED Bangalore IN	100014769;100023445	CEP 2023-351 - Rev 00	2025/04/25	Valid	25/04/2030	Chemical	2025/04/25	New application\|CEP granted\|25/04/2025
141	Ethionamide	APICHEM LABORATORIES PRIVATE LIMITED Yadadri Bhuvanagiri District IN	100049373;100087707	CEP 2024-502 - Rev 00	2025/04/25	Valid	25/04/2030	Chemical	2025/04/25	New application\|CEP granted\|25/04/2025
2577	Oxcarbazepine	ARENE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN	100033956;100079880	CEP 2024-343 - Rev 00	2025/04/25	Valid	25/04/2030	Chemical	2025/04/25	New application\|CEP granted\|25/04/2025
2288	Citalopram hydrobromide, Sulfuric Acid Process, Micronised and non-micronised	ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN	100011833;100018698	CEP 2025-004 - Rev 00	2025/04/25	Valid	25/04/2030	Chemical	2025/04/25	New application\|CEP granted\|25/04/2025
2775	Nebivolol hydrochloride, Micronised	F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT	100011866;100022277	CEP 2024-214 - Rev 00	2025/04/25	Valid	25/04/2030	Chemical	2025/04/25	New application\|CEP granted\|25/04/2025
2244	Tacrolimus monohydrate	CONCORD BIOTECH LIMITED Ahmedabad IN	100005519;100000897	CEP 2018-216 - Rev 01	2025/04/25	Valid		Chemical	2025/04/25	Renewal\|CEP granted\|25/04/2025
1183	Calcium dobesilate monohydrate	BAJAJ HEALTHCARE LIMITED Thane IN	100021782;100061986	CEP 2023-106 - Rev 00	2025/04/25	Valid	25/04/2030	Chemical	2025/04/25	New application\|CEP granted\|25/04/2025
2933	Deferasirox	AMOLI ORGANICS PRIVATE LIMITED Mumbai IN	100016500;100025303	CEP 2021-176 - Rev 01	2025/04/25	Valid	23/10/2028	Chemical	2025/04/25	Minor revision\|CEP granted\|25/04/2025; New application\|CEP granted\|23/10/2023
2778	Sitagliptin phosphate monohydrate, (1466)	MACLEODS PHARMACEUTICALS LIMITED Mumbai IN	100021441;100077265	CEP 2023-205 - Rev 01	2025/04/25	Valid	12/02/2029	Chemical	2025/04/25	Notification\|CEP granted\|25/04/2025; New application\|CEP granted\|12/02/2024

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)	-