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	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN	100051463;100098142	CEP 2015-023 - Rev 02	2025/09/30	Valid		Chemical	2025/09/30	Notification\|CEP granted\|30/09/2025; Notification\|CEP granted\|29/07/2024; Renewal\|CEP granted\|26/11/2021; Minor revision\|CEP granted\|09/12/2020
330	Gelatin, Limed bone gelatin	NITTA GELATIN INDIA LIMITED Ernakulam IN	100032296;100097649	CEP 2020-193 - Rev 01	2025/09/30	Valid		TSE	2025/09/30	Renewal\|CEP granted\|30/09/2025; New application\|CEP granted\|05/01/2021
1665	Betahistine dihydrochloride	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN	100051463;100098142	CEP 2022-505 - Rev 02	2025/09/30	Valid	25/08/2028	Chemical	2025/09/30	Notification\|CEP granted\|30/09/2025; Notification\|CEP granted\|18/07/2024; New application\|CEP granted\|25/08/2023
2815	Entecavir monohydrate	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2017-043 - Rev 02	2025/09/30	Valid		Chemical	2025/09/30	Minor revision\|CEP granted\|30/09/2025; Notification\|CEP granted\|06/12/2023; Renewal\|CEP granted\|03/01/2023
2541	Quetiapine Fumarate	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN	100051463;100098142	CEP 2014-224 - Rev 04	2025/09/29	Valid		Chemical	2025/09/29	Notification\|CEP granted\|29/09/2025; Notification\|CEP granted\|25/07/2024; Minor revision\|Accepted - CEP remains valid\|30/04/2024; Minor revision\|CEP granted\|02/12/2022; Notification\|CEP granted\|31/08/2021; Renewal\|CEP granted\|16/03/2021
2124	Loratadine, Form I	ZYDUS LIFESCIENCES LIMITED Vadodara IN	100005979;100074301	CEP 2007-254 - Rev 04	2025/09/29	Valid		Chemical	2025/09/29	Minor revision\|CEP granted\|29/09/2025; Notification\|CEP granted\|07/07/2022; Minor revision\|CEP granted\|22/04/2020
2422	Oseltamivir phosphate	SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN	100032307;100078783	CEP 2015-348 - Rev 03	2025/09/29	Valid		Chemical	2025/09/29	Minor revision\|CEP granted\|29/09/2025; Renewal\|CEP granted\|28/03/2024; Major revision\|CEP granted\|03/12/2021
1794	Paclitaxel, Semi-synthetic process	FRESENIUS KABI ONCOLOGY LIMITED Kalyani IN	100011513;100018607	CEP 2008-181 - Rev 12	2025/09/29	Valid		Chemical	2025/09/29	Minor revision\|CEP granted\|29/09/2025; Major revision\|CEP granted\|21/03/2025; Major revision\|Accepted - CEP remains valid\|31/10/2023; Major revision\|CEP granted\|17/10/2022; Notification\|Accepted - CEP remains valid\|17/06/2022; Administrative procedure\|CEP granted\|09/05/2022; Major revision\|CEP granted\|29/04/2022; Minor revision\|Accepted - CEP remains valid\|27/11/2020; Administrative procedure\|CEP granted\|29/04/2020; Minor revision\|CEP granted\|31/03/2020
2591	Celecoxib	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN	100051463;100098142	CEP 2012-183 - Rev 06	2025/09/29	Valid		Chemical	2025/09/29	Notification\|CEP granted\|29/09/2025; Minor revision\|CEP granted\|27/03/2025; Notification\|CEP granted\|18/07/2024; Minor revision\|CEP granted\|15/02/2023; Minor revision\|CEP granted\|26/09/2022
2606	Tadalafil, Process II	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN	100051463;100098142	CEP 2019-201 - Rev 04	2025/09/29	Valid		Chemical	2025/09/29	Notification\|CEP granted\|29/09/2025; Renewal\|CEP granted\|02/01/2025; Notification\|CEP granted\|18/07/2024; Minor revision\|CEP granted\|27/02/2023
2733	Escitalopram oxalate, Process II	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN	100051463;100098142	CEP 2019-130 - Rev 04	2025/09/29	Valid		Chemical	2025/09/29	Notification\|CEP granted\|29/09/2025; Renewal\|CEP granted\|21/03/2025; Notification\|CEP granted\|29/07/2024; Minor revision\|CEP granted\|13/07/2023
2778	Sitagliptin phosphate monohydrate, Crystalline, micronised and non-micronised	MSN PHARMACHEM PRIVATE LIMITED Sangareddy District IN	100014794;100023345	CEP 2016-262 - Rev 02	2025/09/29	Valid		Chemical	2025/09/29	Major revision\|CEP granted\|29/09/2025; Renewal\|CEP granted\|12/01/2024; Minor revision\|Accepted - CEP remains valid\|01/03/2022; Notification\|Accepted - CEP remains valid\|15/12/2020
2203	Citalopram hydrochloride, Process II	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN	100051463;100098142	CEP 2019-233 - Rev 03	2025/09/29	Valid		Chemical	2025/09/29	Notification\|CEP granted\|29/09/2025; Renewal\|CEP granted\|07/05/2025; Notification\|CEP granted\|29/07/2024
2338	Mirtazapine, Process-II	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN	100051463;100098142	CEP 2019-127 - Rev 04	2025/09/29	Valid		Chemical	2025/09/29	Notification\|CEP granted\|29/09/2025; Renewal\|CEP granted\|06/02/2025; Notification\|CEP granted\|18/07/2024; Minor revision\|CEP granted\|28/10/2022
626	Neostigmine metilsulfate	MAC CHEM PRODUCTS (INDIA) PRIVATE LIMITED Mumbai IN	100023737;100061579	CEP 2019-024 - Rev 02	2025/09/29	Valid		Chemical	2025/09/29	Renewal\|CEP granted\|29/09/2025; Administrative procedure\|CEP granted\|30/04/2024
572	Timolol maleate	MICRO LABS LIMITED Bengaluru IN	100017819;100077269	CEP 2022-322 - Rev 01	2025/09/29	Valid	28/06/2028	Chemical	2025/09/29	Minor revision\|CEP granted\|29/09/2025; New application\|CEP granted\|28/06/2023
875	Tranexamic acid	AMI LIFESCIENCES PRIVATE LIMITED Vadodara IN	100021822;100030527	CEP 2019-250 - Rev 04	2025/09/29	Valid	28/07/2026	Chemical	2025/09/29	Major revision\|CEP granted\|29/09/2025; Minor revision\|CEP granted\|02/01/2025; Administrative procedure\|CEP granted\|04/04/2022; Notification\|CEP granted\|18/01/2022
285	Noradrenaline tartrate	HAMELN RDS S.R.O. Modra SK	100000646;100003437	CEP 2023-090 - Rev 02	2025/09/29	Valid	25/07/2029	Chemical	2025/09/29	Minor revision\|CEP granted\|29/09/2025; Administrative procedure\|CEP granted\|01/08/2024; New application\|CEP granted\|26/07/2024
2887	Raltegravir potassium	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN	100051463;100098142	CEP 2020-216 - Rev 02	2025/09/29	Valid	25/07/2027	Chemical	2025/09/29	Notification\|CEP granted\|29/09/2025; Notification\|CEP granted\|25/07/2024; Monograph revision\|Accepted - CEP remains valid\|30/03/2023; New application\|CEP granted\|25/07/2022
2779	Solifenacin succinate, Process-II	MICRO LABS LIMITED Bengaluru IN	100017819;100077269	CEP 2021-510 - Rev 02	2025/09/26	Valid	20/06/2027	Chemical	2025/09/26	Minor revision\|CEP granted\|26/09/2025; Major revision\|CEP granted\|19/12/2024; Minor revision\|Accepted - CEP remains valid\|05/07/2024; New application\|CEP granted\|20/06/2022

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)	-