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
2258	Olanzapine	JUBILANT BIOSYS LIMITED Nanjangud IN	100055198;100098088	CEP 2011-030 - Rev 02	2025/09/04	Valid		Chemical	2025/09/04	Notification\|CEP granted\|04/09/2025; Minor revision\|Accepted - CEP remains valid\|28/03/2024; Major revision\|CEP granted\|12/10/2022; Minor revision\|Rejected\|26/07/2022
2288	Citalopram hydrobromide	JUBILANT BIOSYS LIMITED Nanjangud IN	100055198;100098088	CEP 2009-175 - Rev 06	2025/09/04	Valid		Chemical	2025/09/04	Notification\|CEP granted\|04/09/2025; Notification\|CEP granted\|10/07/2023; Notification\|CEP granted\|11/08/2022; Minor revision\|CEP granted\|23/06/2021; Notification\|Rejected\|07/05/2021; Major revision\|CEP granted\|18/05/2020
2173	Gabapentin	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2013-167 - Rev 04	2025/09/04	Valid		Chemical	2025/09/04	Minor revision\|CEP granted\|04/09/2025; Minor revision\|CEP granted\|08/07/2024; Minor revision\|CEP granted\|20/09/2023; Minor revision\|CEP granted\|30/08/2022
1681	Tramadol hydrochloride	JUBILANT BIOSYS LIMITED Nanjangud IN	100055198;100098088	CEP 2002-199 - Rev 08	2025/09/04	Valid		Chemical	2025/09/04	Notification\|CEP granted\|04/09/2025; Major revision\|Accepted - CEP remains valid\|23/08/2024; Notification\|CEP granted\|11/08/2022; Minor revision\|Accepted - CEP remains valid\|21/05/2021
1559	Risperidone, 'RIS'	JUBILANT BIOSYS LIMITED Nanjangud IN	100055198;100098088	CEP 2006-046 - Rev 04	2025/09/04	Valid		Chemical	2025/09/04	Notification\|CEP granted\|04/09/2025; Notification\|CEP granted\|23/08/2022
203	Polymyxin B sulfate	HEBEI SHENGXUE DACHENG PHARMACEUTICAL CO. LTD. Shijiazhuang City CN	100016575;100025368	CEP 2024-389 - Rev 00	2025/09/03	Valid	03/09/2030	Chemical	2025/09/03	New application\|CEP granted\|03/09/2025
1012	Famotidine	SMS LIFESCIENCES INDIA LIMITED Hyderabad IN	100039495;100077080	CEP 2023-455 - Rev 00	2025/09/03	Valid	03/09/2030	Chemical	2025/09/03	New application\|CEP granted\|03/09/2025
653	Baclofen	PCAS Ecully FR	100011754;100054740	CEP 2003-247 - Rev 02	2025/09/02	Valid		Chemical	2025/09/02	Monograph revision\|CEP granted\|02/09/2025; Notification\|Accepted - CEP remains valid\|03/06/2021; Notification\|CEP granted\|30/07/2020
49	Paracetamol	GRANULES INDIA LIMITED Hyderabad IN	100011671;100097387	CEP 1998-047 - Rev 07	2025/09/02	Valid		Chemical	2025/09/02	Notification\|CEP granted\|02/09/2025; Minor revision\|Accepted - CEP remains valid\|28/04/2023; Minor revision\|Accepted - CEP remains valid\|28/10/2022; Monograph revision\|Accepted - CEP remains valid\|23/03/2022; Minor revision\|Accepted - CEP remains valid\|26/11/2021; Minor revision\|Accepted - CEP remains valid\|10/09/2021; Minor revision\|Accepted - CEP remains valid\|18/06/2020
731	Naproxen	ZHEJIANG CHARIOTEER PHARMACEUTICAL CO., LTD Xianju CN	100011826;100018693	CEP 2006-270 - Rev 03	2025/09/02	Valid		Chemical	2025/09/02	Minor revision\|CEP granted\|02/09/2025; Notification\|Accepted - CEP remains valid\|10/11/2023; Notification\|Accepted - CEP remains valid\|06/01/2022; Minor revision\|Accepted - CEP remains valid\|26/06/2020
464	Amitriptyline hydrochloride	R.L. FINE CHEM PRIVATE LIMITED Chikkaballapur IN	100016723;100053383	CEP 2004-214 - Rev 06	2025/09/02	Valid		Chemical	2025/09/02	Notification\|CEP granted\|02/09/2025; Minor revision\|CEP granted\|03/04/2024
1745	Carvedilol	ZAKŁADY FARMACEUTYCZNE POLPHARMA S.A. Starogard Gdański PL	100000470;100001572	CEP 2002-258 - Rev 09	2025/09/02	Valid		Chemical	2025/09/02	Minor revision\|CEP granted\|02/09/2025; Major revision\|CEP granted\|22/10/2021; Minor revision\|CEP granted\|22/01/2021
1756	Lamotrigine	JUBILANT BIOSYS LIMITED Nanjangud IN	100055198;100098088	CEP 2009-162 - Rev 03	2025/09/02	Valid		Chemical	2025/09/02	Notification\|CEP granted\|02/09/2025; Notification\|CEP granted\|12/08/2022
2577	Oxcarbazepine	JUBILANT BIOSYS LIMITED Nanjangud IN	100055198;100098088	CEP 2014-059 - Rev 04	2025/09/02	Valid		Chemical	2025/09/02	Notification\|CEP granted\|02/09/2025; Minor revision\|CEP granted\|02/04/2025; Minor revision\|CEP granted\|14/10/2024; Major revision\|Accepted - CEP remains valid\|18/03/2024; Minor revision\|Accepted - CEP remains valid\|28/10/2022; Notification\|Rejected\|04/10/2022; Notification\|CEP granted\|11/08/2022; Notification\|Accepted - CEP remains valid\|27/08/2020; Renewal\|CEP granted\|18/05/2020
50	Procaine Hydrochloride, Process H	CHONGQING SOUTHWEST No.2 PHARMACEUTICAL FACTORY CO., LTD. Chongqing CN	100014817;100023402	CEP 2024-577 - Rev 00	2025/09/02	Valid	02/09/2030	Chemical	2025/09/02	New application\|CEP granted\|02/09/2025
615	Guaifenesin, BPL site	GRANULES INDIA LIMITED Hyderabad IN	100011671;100097387	CEP 2021-332 - Rev 01	2025/09/02	Valid	10/12/2026	Chemical	2025/09/02	Notification\|CEP granted\|02/09/2025; Minor revision\|Accepted - CEP remains valid\|06/07/2022; New application\|CEP granted\|10/12/2021
2191	Atorvastatin calcium, Process-II	AMOLI ORGANICS PRIVATE LIMITED Mumbai IN	100016500;100025303	CEP 2025-318 - Rev 00	2025/09/02	Valid	02/09/2030	Chemical	2025/09/02	New application\|CEP granted\|02/09/2025
2598	Levofloxacin hemihydrate	MSN LIFE SCIENCES PRIVATE LIMITED Medak IN	100018316;100027671	CEP 2021-016 - Rev 01	2025/09/02	Valid	22/08/2028	Chemical	2025/09/02	Minor revision\|CEP granted\|02/09/2025; New application\|CEP granted\|22/08/2023
931	Metformin Hydrochloride, BPL Site	GRANULES INDIA LIMITED Hyderabad IN	100011671;100097387	CEP 2018-120 - Rev 02	2025/09/02	Valid		Chemical	2025/09/02	Notification\|CEP granted\|02/09/2025; Renewal\|CEP granted\|12/12/2023; Minor revision\|Accepted - CEP remains valid\|25/11/2022; Minor revision\|Accepted - CEP remains valid\|22/09/2020; Monograph revision\|Accepted - CEP remains valid\|24/03/2020
2154	Telmisartan, Process IV, micronised and non-micronised	ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN	100011833;100018698	CEP 2023-181 - Rev 01	2025/09/01	Valid	03/04/2029	Chemical	2025/09/01	Minor revision\|CEP granted\|01/09/2025; Notification\|Accepted - CEP remains valid\|11/07/2024; New application\|CEP granted\|03/04/2024

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)	-