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
2616	Topiramate	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2020-140 - Rev 04	2025/03/21	Valid	14/06/2027	Chemical	2025/03/21	Minor revision\|CEP granted\|21/03/2025; Notification\|CEP granted\|18/12/2023; Minor revision\|CEP granted\|28/02/2023; Minor revision\|CEP granted\|15/09/2022; New application\|CEP granted\|14/06/2022
653	Baclofen	BIOINDUSTRIA L.I.M. S.P.A. Novi Ligure IT	100001870;100092872	CEP 2011-360 - Rev 02	2025/03/21	Valid		Chemical	2025/03/21	Monograph revision\|CEP granted\|21/03/2025; Minor revision\|CEP granted\|09/09/2020
2270	Sildenafil citrate	AMOLI ORGANICS PRIVATE LIMITED Mumbai IN	100016500;100025303	CEP 2014-223 - Rev 02	2025/03/21	Valid		Chemical	2025/03/21	Major revision\|CEP granted\|21/03/2025; Minor revision\|Accepted - CEP remains valid\|02/08/2023; Minor revision\|Accepted - CEP remains valid\|09/03/2023; Minor revision\|Accepted - CEP remains valid\|24/01/2022; Major revision\|CEP granted\|04/02/2021; Renewal\|CEP granted\|29/09/2020
3115	Levocetirizine dihydrochloride	GLOCHEM INDUSTRIES PRIVATE LIMITED Hyderabad IN	100012012;100020318	CEP 2024-049 - Rev 00	2025/03/21	Valid	21/03/2030	Chemical	2025/03/21	New application\|CEP granted\|21/03/2025
1508	Diclofenac potassium	OLON S.P.A. Rodano IT	100012085;100019537	CEP 2010-286 - Rev 05	2025/03/21	Valid		Chemical	2025/03/21	Minor revision\|CEP granted\|21/03/2025; Minor revision\|CEP granted\|24/03/2022
1081	Carboplatin	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2000-375 - Rev 05	2025/03/21	Valid		Chemical	2025/03/21	Minor revision\|CEP granted\|21/03/2025; Minor revision\|CEP granted\|13/04/2022
663	Dicloxacillin sodium monohydrate, Powder and compacted	FRESENIUS KABI IPSUM S.R.L. Cassina de’ Pecchi IT	100015105;100057989	CEP 2002-036 - Rev 09	2025/03/21	Valid		Chemical	2025/03/21	Administrative procedure\|CEP granted\|21/03/2025; Notification\|CEP granted\|14/03/2025; Minor revision\|CEP granted\|16/08/2021; Notification\|CEP granted\|02/02/2021
15	Calcium chloride dihydrate	CFL CHEMISCHE FABRIK LEHRTE GMBH & CO. KG Lehrte DE	100021016;100029727	CEP 2015-352 - Rev 02	2025/03/21	Valid		Chemical	2025/03/21	Notification\|CEP granted\|21/03/2025; Minor revision\|CEP granted\|16/01/2024; Renewal\|CEP granted\|01/03/2022; Notification\|Accepted - CEP remains valid\|09/09/2021
1756	Lamotrigine	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2011-178 - Rev 04	2025/03/21	Valid		Chemical	2025/03/21	Minor revision\|CEP granted\|21/03/2025; Minor revision\|CEP granted\|18/09/2023; Notification\|CEP granted\|20/12/2021; Notification\|CEP granted\|20/05/2021
402	Magnesium chloride hexahydrate	CFL CHEMISCHE FABRIK LEHRTE GMBH & CO. KG Lehrte DE	100021016;100029727	CEP 2017-044 - Rev 01	2025/03/21	Valid		Chemical	2025/03/21	Notification\|CEP granted\|21/03/2025; Notification\|Accepted - CEP remains valid\|22/06/2023; Renewal\|CEP granted\|25/01/2023; Notification\|Accepted - CEP remains valid\|23/08/2021
260	Amoxicillin trihydrate, Compacted	SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD Datong CN	100033465;100052362	CEP 2021-461 - Rev 02	2025/03/21	Valid	18/05/2027	Chemical	2025/09/26	Minor revision\|Accepted - CEP remains valid\|26/09/2025; Minor revision\|CEP granted\|21/03/2025; Minor revision\|CEP granted\|20/12/2023; New application\|CEP granted\|18/05/2022
2768	Fluticasone furoate	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2022-015 - Rev 02	2025/03/21	Valid	03/08/2028	Chemical	2025/03/21	Notification\|CEP granted\|21/03/2025; Minor revision\|CEP granted\|11/03/2024; New application\|CEP granted\|03/08/2023
767	Fludrocortisone acetate	HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN	100016183;100024971	CEP 2021-435 - Rev 01	2025/03/21	Valid	21/05/2029	Chemical	2025/03/21	Monograph revision\|CEP granted\|21/03/2025; New application\|CEP granted\|21/05/2024
1699	Mesalazine	MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN	100018316;100070723	CEP 2024-351 - Rev 00	2025/03/20	Valid	20/03/2030	Chemical	2025/03/20	New application\|CEP granted\|20/03/2025
1912	Fish oil, rich in omega-3-acids, Type I	CHEMPORT INC. Naju-si KR	100023666;100032833	CEP 2015-282 - Rev 01	2025/03/20	Valid		Chemical	2025/03/20	Minor revision\|CEP granted\|20/03/2025; Renewal\|CEP granted\|17/03/2022; Minor revision\|Accepted - CEP remains valid\|02/02/2021
941	Nortriptyline hydrochloride	VASUDHA PHARMA CHEM LIMITED Hyderabad IN	100011811;100018603	CEP 2017-066 - Rev 01	2025/03/20	Valid		Chemical	2025/03/20	Minor revision\|CEP granted\|20/03/2025; Renewal\|CEP granted\|31/07/2023; Notification\|CEP granted\|02/02/2023; Minor revision\|Accepted - CEP remains valid\|06/05/2020
1513	Etofenamate	ESTEVE QUIMICA S.A. Barcelona ES	100002266;100056508	CEP 2012-114 - Rev 03	2025/03/20	Valid		Chemical	2025/03/20	Minor revision\|CEP granted\|20/03/2025; Notification\|Accepted - CEP remains valid\|13/05/2024; Notification\|Accepted - CEP remains valid\|26/01/2023; Notification\|Rejected\|08/12/2022; Transfer of holdership\|CEP granted\|16/03/2022; Administrative procedure\|CEP granted\|23/10/2020
2416	Pramipexole dihydrochloride monohydrate	MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN	100011732;100018657	CEP 2011-050 - Rev 02	2025/03/20	Valid		Chemical	2025/03/20	Minor revision\|CEP granted\|20/03/2025; Notification\|Accepted - CEP remains valid\|28/10/2021; Notification\|Rejected\|10/09/2021; Minor revision\|CEP granted\|18/08/2020
3095	Dabigatran etexilate mesilate, Form I	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2024-114 - Rev 01	2025/03/20	Valid	15/01/2030	Chemical	2025/11/04	Minor revision\|Rejected\|04/11/2025; Notification\|CEP granted\|20/03/2025; New application\|CEP granted\|15/01/2025
1489	Ambroxol hydrochloride	KORES (INDIA) LIMITED Navi Mumbai IN	100020521;100087957	CEP 2022-242 - Rev 00	2025/03/20	Valid	20/03/2030	Chemical	2025/09/05	Minor revision\|Accepted - CEP remains valid\|05/09/2025; Notification\|Rejected\|22/08/2025; New application\|CEP granted\|21/03/2025

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)	-