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
2780	Temozolomide	FORMOSA LABORATORIES, INC. Taoyuan TW	100011879;100018688	CEP 2017-245 - Rev 02	2025/07/09	Valid		Chemical	2025/07/09	Notification\|CEP granted\|09/07/2025; Renewal\|CEP granted\|26/04/2024; Notification\|Accepted - CEP remains valid\|07/07/2022
1004	Diltiazem hydrochloride	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 1997-077 - Rev 16	2025/07/09	Valid		Chemical	2025/09/16	Notification\|Accepted - CEP remains valid\|16/09/2025; Minor revision\|CEP granted\|09/07/2025; Notification\|CEP granted\|12/03/2025; Notification\|Accepted - CEP remains valid\|10/10/2024; Minor revision\|CEP granted\|13/12/2021; Minor revision\|CEP granted\|25/09/2020
1472	Sodium hyaluronate, Intrinsic viscosity 2.93 m3/kg, by fermentation, for parenteral administration including intra-articular administration and for intra-ocular use	KEWPIE CORP. Tokyo JP	100039277;100093553	CEP 2019-064 - Rev 01	2025/07/09	Valid		Chemical and TSE	2025/07/09	Renewal\|CEP granted\|09/07/2025; Minor revision\|Accepted - CEP remains valid\|01/12/2020
2330	Leflunomide	FORMOSA LABORATORIES, INC. Taoyuan TW	100011879;100018688	CEP 2009-035 - Rev 03	2025/07/09	Valid		Chemical	2025/07/09	Notification\|CEP granted\|09/07/2025; Minor revision\|CEP granted\|12/05/2025
734	Prednisolone acetate, Micronised, sterile, alternative process	FARMABIOS S.p.A Gropello Cairoli IT	100011643;100021232	CEP 2024-549 - Rev 00	2025/07/09	Valid	09/07/2030	Chemical	2025/07/09	New application\|CEP granted\|09/07/2025
3132	Mirabegron, α-Form	MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN	100011732;100018657	CEP 2024-031 - Rev 00	2025/07/09	Valid	09/07/2030	Chemical	2025/07/09	New application\|CEP granted\|09/07/2025
2591	Celecoxib	AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN	100046306;100076393	CEP 2019-112 - Rev 01	2025/07/09	Valid		Chemical	2026/01/07	Renewal\|Accepted - CEP remains valid\|07/01/2026; Minor revision\|CEP granted\|09/07/2025
2640	Atomoxetine hydrochloride, Process 2	COHANCE LIFESCIENCES LIMITED Mumbai IN	100011755;100090273	CEP 2019-212 - Rev 03	2025/07/09	Valid		Chemical	2025/07/09	Renewal\|CEP granted\|09/07/2025; Notification\|CEP granted\|10/07/2024; Notification\|CEP granted\|12/02/2021
929	Loperamide hydrochloride	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2008-313 - Rev 04	2025/07/08	Valid		Chemical	2025/07/08	Notification\|CEP granted\|08/07/2025; Minor revision\|Accepted - CEP remains valid\|19/06/2024; Minor revision\|Accepted - CEP remains valid\|08/08/2022; Notification\|CEP granted\|04/01/2022; Notification\|Accepted - CEP remains valid\|02/02/2021
1538	Lovastatin	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2000-406 - Rev 06	2025/07/08	Valid		Chemical	2025/07/08	Administrative procedure\|CEP granted\|08/07/2025; Minor revision\|Accepted - CEP remains valid\|09/05/2025; Minor revision\|Accepted - CEP remains valid\|20/09/2022; Notification\|CEP granted\|23/11/2021; Monograph revision\|CEP granted\|09/08/2021; Minor revision\|Accepted - CEP remains valid\|12/10/2020
2287	Fluconazole	VIRUPAKSHA ORGANICS LIMITED Hyderabad IN	100021606;100076961	CEP 2009-364 - Rev 02	2025/07/08	Valid		Chemical	2025/07/08	Major revision\|CEP granted\|08/07/2025; Minor revision\|CEP granted\|18/09/2023
533	Triamcinolone acetonide	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2009-084 - Rev 03	2025/07/08	Valid		Chemical	2025/07/08	Notification\|CEP granted\|08/07/2025; Notification\|Accepted - CEP remains valid\|05/08/2024; Notification\|Accepted - CEP remains valid\|17/07/2023; Minor revision\|CEP granted\|07/03/2022; Minor revision\|Accepted - CEP remains valid\|31/03/2021
2640	Atomoxetine hydrochloride	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2014-241 - Rev 02	2025/07/08	Valid		Chemical	2025/07/08	Minor revision\|CEP granted\|08/07/2025; Notification\|CEP granted\|17/01/2024; Renewal\|CEP granted\|21/01/2021
2372	Esomeprazole magnesium trihydrate	LEE PHARMA LIMITED Hyderabad IN	100014849;100042625	CEP 2016-284 - Rev 01	2025/07/08	Valid		Chemical	2025/07/08	Minor revision\|CEP granted\|08/07/2025; Renewal\|CEP granted\|12/06/2023; Major revision\|CEP granted\|16/01/2023
967	Acetylcysteine	SEVEN STAR PHARMACEUTICAL COMPANY, LTD. New Taipei City TW	100024386;100033558	CEP 2022-177 - Rev 02	2025/07/08	Valid	29/08/2028	Chemical	2025/07/08	Major revision\|CEP granted\|08/07/2025; Minor revision\|CEP granted\|01/08/2024; New application\|CEP granted\|29/08/2023
2191	Atorvastatin calcium	NINGBO MENOVO PHARMACEUTICAL CO., LTD. Ningbo CN	100030313;100047776	CEP 2019-013 - Rev 01	2025/07/08	Valid		Chemical	2025/07/08	Renewal\|CEP granted\|08/07/2025; Monograph revision\|Accepted - CEP remains valid\|19/07/2022
681	Pancuronium bromide	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2009-391 - Rev 03	2025/07/08	Valid		Chemical	2025/07/08	Notification\|CEP granted\|08/07/2025; Notification\|Accepted - CEP remains valid\|30/01/2023; Notification\|CEP granted\|05/01/2022; Minor revision\|CEP granted\|07/05/2020
2781	Tolterodine tartrate	FLEMING LABORATORIES LIMITED Hyderabad IN	100015641;100067279	CEP 2022-455 - Rev 00	2025/07/08	Valid	08/07/2030	Chemical	2025/07/08	New application\|Abandoned\|08/07/2025
1653	Potassium clavulanate, diluted, with silica, colloidal hydrated in the ratio 1:1	SHANXI SHUANGYAN PHARMACEUTICAL CO., LTD. Datong CN	100052070;100091614	CEP 2024-531 - Rev 00	2025/07/08	Valid	08/07/2030	Chemical	2025/07/08	New application\|CEP granted\|08/07/2025
1653	Potassium clavulanate, diluted, with microcrystalline cellulose in the ratio 1:1	SHANXI SHUANGYAN PHARMACEUTICAL CO., LTD. Datong CN	100052070;100091614	CEP 2024-543 - Rev 00	2025/07/08	Valid	08/07/2030	Chemical	2025/07/08	New application\|CEP granted\|08/07/2025

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)	-