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
3139	Brivaracetam	CHENGDA PHARMACEUTICALS CO., LTD. Jiashan CN	100012006;100020624	CEP 2024-227 - Rev 00	2025/12/22	Valid	22/12/2030	Chemical	2025/12/22	New application\|CEP granted\|22/12/2025
2778	Sitagliptin phosphate monohydrate	WAVELENGTH ENTERPRISES LTD. Petah Tikva IL	100018877;100092992	CEP 2024-213 - Rev 00	2025/12/22	Valid	22/12/2030	Chemical	2025/12/22	New application\|CEP granted\|22/12/2025
2306	Gemcitabine hydrochloride	RAVI BIOLIFE PRIVATE LIMITED Mumbai IN	100048404;100086771	CEP 2023-229 - Rev 01	2025/12/19	Valid	05/08/2029	Chemical	2025/12/19	Minor revision\|CEP granted\|19/12/2025; Minor revision\|Accepted - CEP remains valid\|15/11/2024; New application\|CEP granted\|05/08/2024
1472	Sodium hyaluronate, GS-100, intrinsic viscosity: 1.50 m3/kg; from fermentation; for parenteral administration, including intra-ocular use	KIKKOMAN BIOCHEMIFA CO. Noda City JP	100039417;100087689	CEP 2020-420 - Rev 01	2025/12/19	Valid		Chemical	2025/12/19	Renewal\|CEP granted\|19/12/2025; Minor revision\|Accepted - CEP remains valid\|24/04/2025; Notification\|Accepted - CEP remains valid\|03/05/2024; New application\|CEP granted\|03/03/2021
1362	Prilocaine	SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO., LTD. Dezhou City CN	100048410;100080174	CEP 2024-300 - Rev 00	2025/12/19	Valid	19/12/2030	Chemical	2025/12/19	New application\|CEP granted\|19/12/2025
3095	Dabigatran etexilate mesilate, Micronised, non-micronised	ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN	100012174;100018701	CEP 2024-073 - Rev 02	2025/12/19	Valid	19/08/2030	Chemical	2025/12/19	Minor revision\|CEP granted\|19/12/2025; Minor revision\|CEP granted\|06/11/2025; New application\|CEP granted\|19/08/2025
1425	Fosfomycin trometamol	ZACH SYSTEM Avrillé FR	100012282;100021396	CEP 2020-370 - Rev 04	2025/12/19	Valid	02/09/2026	Chemical	2025/12/19	Minor revision\|CEP granted\|19/12/2025; Notification\|Accepted - CEP remains valid\|02/04/2025; Minor revision\|CEP granted\|12/06/2024; Minor revision\|CEP granted\|03/07/2023; Notification\|Accepted - CEP remains valid\|25/11/2022; Minor revision\|CEP granted\|09/12/2021; New application\|CEP granted\|02/09/2021
2585	Rizatriptan benzoate	EMCURE PHARMACEUTICALS LIMITED Pune IN	100011677;100022690	CEP 2019-095 - Rev 02	2025/12/19	Valid		Chemical	2025/12/19	Renewal\|CEP granted\|19/12/2025; Minor revision\|CEP granted\|29/01/2024
1378	Valproic acid	ANJAN DRUG PRIVATE LIMITED Alathur IN	100023458;100032594	CEP 2003-174 - Rev 04	2025/12/19	Valid		Chemical	2025/12/19	Minor revision\|CEP granted\|19/12/2025; Minor revision\|Accepted - CEP remains valid\|14/09/2023
2541	Quetiapine Fumarate	ZHEJIANG HISOAR CHUANNAN PHARMACEUTICAL CO., LTD. Taizhou City CN	100039329;100061908	CEP 2015-218 - Rev 01	2025/12/19	Valid		Chemical	2025/12/19	Minor revision\|CEP granted\|19/12/2025; Minor revision\|Accepted - CEP remains valid\|18/12/2023; Renewal\|CEP granted\|15/02/2022; Minor revision\|CEP granted\|25/05/2021
15	Calcium chloride dihydrate	Merck KGaA Darmstadt DE	100000742;100006955	CEP 2007-356 - Rev 02	2025/12/19	Valid		Chemical	2025/12/19	Minor revision\|CEP granted\|19/12/2025; Notification\|Accepted - CEP remains valid\|02/07/2025
2777	Pregabalin	KOPRAN RESEARCH LABORATORIES LIMITED Mumbai IN	100033667;100081898	CEP 2018-080 - Rev 04	2025/12/19	Valid		Chemical	2025/12/19	Minor revision\|CEP granted\|19/12/2025; Renewal\|Accepted - CEP remains valid\|26/03/2025; Minor revision\|CEP granted\|14/10/2024; Major revision\|CEP granted\|16/09/2022; Minor revision\|CEP granted\|03/02/2021
1705	Sertraline hydrochloride, Form I	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2008-019 - Rev 07	2025/12/19	Valid		Chemical	2025/12/19	Minor revision\|CEP granted\|19/12/2025; Minor revision\|CEP granted\|02/12/2024; Minor revision\|Accepted - CEP remains valid\|02/07/2024; Minor revision\|CEP granted\|07/02/2024; Major revision\|Rejected\|03/02/2023; Minor revision\|Accepted - CEP remains valid\|08/08/2022; Minor revision\|Accepted - CEP remains valid\|25/05/2022; Minor revision\|Accepted - CEP remains valid\|31/03/2022
691	alpha-Tocopheryl acetate concentrate (powder form), 50 g per 100 g of concentrate	DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH	100053293;100094111	CEP 2019-086 - Rev 02	2025/12/19	Valid		Chemical	2025/12/19	Renewal\|CEP granted\|19/12/2025; Notification\|CEP granted\|16/07/2025
2535	Levetiracetam	CHIERON ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN	100053345;100094249	CEP 2023-046 - Rev 02	2025/12/18	Valid	15/05/2029	Chemical	2025/12/18	Minor revision\|CEP granted\|18/12/2025; Notification\|CEP granted\|17/06/2025; New application\|CEP granted\|15/05/2024
1556	Piretanide, Micronised	ZENTIVA K.S. Prague CZ	100004108;100097772	CEP 2024-234 - Rev 01	2025/12/18	Valid	14/11/2030	Chemical	2025/12/18	Administrative procedure\|CEP granted\|18/12/2025; New application\|CEP granted\|14/11/2025
.	N-(Methylpolyoxyethylene oxycarbonyl)-1,2-dipalmitoyl-sn-glycero-3-phosphoethanolamine, sodium salt	NOF CORP. Shibuya JP	100013118;100097453	CEP 2025-351 - Rev 00	2025/12/18	Valid	18/12/2030	TSE	2025/12/18	New application\|CEP granted\|18/12/2025
1281	Aceclofenac	HENAN DONGTAI PHARM CO., LTD. Anyang CN	100023192;100052097	CEP 2023-072 - Rev 01	2025/12/18	Valid	25/07/2029	Chemical	2025/12/18	Minor revision\|CEP granted\|18/12/2025; New application\|CEP granted\|26/07/2024
2258	Olanzapine, Form-I, Micronised	CADILA PHARMACEUTICALS LIMITED Ankleshwar IN	100003616;100000498	CEP 2024-469 - Rev 00	2025/12/18	Valid	18/12/2030	Chemical	2025/12/18	New application\|CEP granted\|18/12/2025
926	Levonorgestrel, Process 2	INDUSTRIALE CHIMICA S.R.L. Saronno IT	100011692;100020331	CEP 2025-476 - Rev 00	2025/12/18	Valid	18/12/2030	Chemical	2025/12/18	New application\|CEP granted\|18/12/2025

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)	-