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
2372	Esomeprazole magnesium trihydrate, Unit IV	NOSCH LABS PRIVATE LIMITED Hyderabad IN	100020550;100089573	CEP 2020-343 - Rev 02	2026/03/23	Valid		Chemical	2026/03/23	Renewal\|CEP granted\|23/03/2026; Minor revision\|CEP granted\|09/09/2025; New application\|CEP granted\|18/01/2021
1491	Amlodipine besilate	KOPRAN RESEARCH LABORATORIES LIMITED Mumbai IN	100033667;100081898	CEP 2021-242 - Rev 01	2026/03/23	Valid	03/06/2030	Chemical	2026/03/23	Monograph revision\|CEP granted\|23/03/2026; New application\|CEP granted\|03/06/2025
49	Paracetamol, PNCB route	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2025-428 - Rev 00	2026/03/23	Valid	23/03/2031	Chemical	2026/03/23	New application\|CEP granted\|23/03/2026
560	Methotrexate	SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN	100044578;100073706	CEP 2024-465 - Rev 00	2026/03/23	Valid	23/03/2031	Chemical	2026/03/23	New application\|CEP granted\|23/03/2026
3087	Ticagrelor, Polymorphic Form II (Process A)	ZHEJIANG AUSUN PHARMACEUTICAL CO., LTD. Taizhou CN	100014719;100023221	CEP 2025-604 - Rev 00	2026/03/23	Valid	23/03/2031	Chemical	2026/03/23	New application\|CEP granted\|23/03/2026
1075	Budesonide, Micronised	AURISCO PHARMACEUTICAL CO., LTD. Tiantai CN	100011968;100018590	CEP 2025-046 - Rev 00	2026/03/23	Valid	23/03/2031	Chemical	2026/03/23	New application\|CEP granted\|23/03/2026
2778	Sitagliptin phosphate monohydrate	MSN LIFE SCIENCES PRIVATE LIMITED Kamareddy IN	100018316;100070723	CEP 2024-526 - Rev 00	2026/03/23	Valid	23/03/2031	Chemical	2026/03/23	New application\|CEP granted\|23/03/2026
2258	Olanzapine	TORRENT PHARMACEUTICALS LIMITED Ahmedabad IN	100004452;100001862	CEP 2013-177 - Rev 05	2026/03/20	Valid		Chemical	2026/03/20	Minor revision\|CEP granted\|20/03/2026; Notification\|CEP granted\|11/01/2024; Notification\|CEP granted\|02/11/2023; Minor revision\|CEP granted\|06/10/2023; Minor revision\|Accepted - CEP remains valid\|01/03/2021
1519	Flurbiprofen, Process II	SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN	100008538;100018201	CEP 2021-039 - Rev 02	2026/03/20	Valid		Chemical	2026/03/20	Renewal\|CEP granted\|20/03/2026; Monograph revision\|CEP granted\|10/01/2023; New application\|CEP granted\|15/04/2021
883	Calcitriol	CARBOGEN AMCIS B.V. Veenendaal NL	100002010;100009870	CEP 1996-009 - Rev 14	2026/03/20	Valid		Chemical and TSE	2026/03/20	Minor revision\|CEP granted\|20/03/2026; Notification\|Rejected\|05/02/2026; Monograph revision\|CEP granted\|13/12/2024; Notification\|CEP granted\|03/03/2020
1794	Paclitaxel, Produced by a semi-synthetic process, product code SPT 1308	SCINOPHARM TAIWAN LTD. Tainan TW	100012108;100019515	CEP 2015-278 - Rev 02	2026/03/20	Valid		Chemical	2026/03/20	Minor revision\|CEP granted\|20/03/2026; Notification\|CEP granted\|11/09/2024; Renewal\|CEP granted\|10/06/2022; Minor revision\|CEP granted\|25/06/2020
2775	Nebivolol hydrochloride, Non-micronised, micronised	ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN	100011833;100018698	CEP 2022-140 - Rev 02	2026/03/19	Valid	22/06/2028	Chemical	2026/03/19	Minor revision\|CEP granted\|19/03/2026; Minor revision\|CEP granted\|20/12/2023; New application\|CEP granted\|22/06/2023
2366	Galantamine hydrobromide, Isolated from natural sources	GALEN-N EOOD Sofia BG	100049230;100083398	CEP 2024-450 - Rev 00	2026/03/19	Valid	19/03/2031	Chemical	2026/03/19	New application\|CEP granted\|19/03/2026
760	Cytarabine	SAKAR HEALTHCARE LIMITED Ahmedabad IN	100033943;100085048	CEP 2025-029 - Rev 00	2026/03/19	Valid	19/03/2031	Chemical	2026/03/19	New application\|CEP granted\|19/03/2026
565	Sodium nitroprusside	MICRO LABS LIMITED Bengaluru IN	100017819;100077269	CEP 2024-206 - Rev 00	2026/03/19	Valid	19/03/2031	Chemical	2026/03/19	New application\|CEP granted\|19/03/2026
2173	Gabapentin, Site Yongtai Chiral	ZHEJIANG YONGTAI CHIRAL MEDICINE TECHNOLOGY CO. LTD. Taizhou CN	100041319;100068021	CEP 2022-303 - Rev 01	2026/03/19	Valid	27/10/2027	Chemical	2026/03/19	Minor revision\|CEP granted\|19/03/2026; Minor revision\|Accepted - CEP remains valid\|16/09/2024; New application\|CEP granted\|27/10/2022
2591	Celecoxib, Micronised and non-micronised	KEKULE PHARMA LIMITED Hyderabad IN	100033239;100051871	CEP 2023-274 - Rev 01	2026/03/19	Valid	03/11/2030	Chemical	2026/03/19	Minor revision\|CEP granted\|19/03/2026; New application\|CEP granted\|03/11/2025
827	Gonadorelin acetate	PIRAMAL PHARMA LIMITED Navi Mumbai IN	100036948;100075608	CEP 2025-161 - Rev 00	2026/03/19	Valid	19/03/2031	Chemical	2026/03/19	New application\|CEP granted\|19/03/2026
353	Prednisolone	TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. Tianjin CN	100011805;100018616	CEP 2002-108 - Rev 05	2026/03/19	Valid		Chemical	2026/03/19	Minor revision\|CEP granted\|19/03/2026; Major revision\|Rejected\|10/06/2020
740	Sulfadoxine	ANUH PHARMA LIMITED Mumbai IN	100021566;100030259	CEP 2022-457 - Rev 01	2026/03/19	Valid	23/02/2029	Chemical	2026/03/19	Minor revision\|CEP granted\|19/03/2026; Notification\|Accepted - CEP remains valid\|06/11/2024; New application\|CEP granted\|23/02/2024

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)	-