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
2531	Clopidogrel hydrogen sulfate, Form II	DR. REDDY'S LABORATORIES LIMITED Hyderabad IN	100003991;100000217	CEP 2021-052 - Rev 02	2026/05/07	Valid	17/08/2027	Chemical	2026/05/07	Administrative procedure\|CEP granted\|07/05/2026; Minor revision\|Accepted - CEP remains valid\|29/10/2025; Minor revision\|Accepted - CEP remains valid\|14/09/2023; Minor revision\|Accepted - CEP remains valid\|12/05/2023; Minor revision\|CEP granted\|20/02/2023; New application\|CEP granted\|17/08/2022
2002	Proguanil hydrochloride	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2011-182 - Rev 02	2026/05/05	Valid		Chemical	2026/05/05	Minor revision\|CEP granted\|05/05/2026; Minor revision\|CEP granted\|24/06/2025; Notification\|Accepted - CEP remains valid\|08/01/2024; Minor revision\|Accepted - CEP remains valid\|19/04/2022; Notification\|Accepted - CEP remains valid\|15/01/2021
1794	Paclitaxel, Produced by a semi-synthetic process	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2021-476 - Rev 01	2026/05/05	Valid	28/07/2028	Chemical	2026/05/05	Minor revision\|CEP granted\|05/05/2026; Minor revision\|Rejected\|09/01/2026; New application\|CEP granted\|28/07/2023
2338	Mirtazapine	MAHI DRUGS PRIVATE LIMITED Hyderabad IN	100048039;100079525	CEP 2024-394 - Rev 00	2026/05/05	Valid	05/05/2031	Chemical	2026/05/05	New application\|CEP granted\|05/05/2026
2018	Paroxetine hydrochloride hemihydrate	IPCA LABORATORIES LIMITED Mumbai IN	100011685;100018680	CEP 2014-095 - Rev 01	2026/05/04	Valid		Chemical	2026/05/04	Minor revision\|CEP granted\|04/05/2026; Minor revision\|Accepted - CEP remains valid\|20/11/2023; Notification\|Accepted - CEP remains valid\|23/06/2023; Minor revision\|Accepted - CEP remains valid\|14/06/2022; Renewal\|CEP granted\|11/01/2021
2646	Terlipressin	POLYPEPTIDE LABORATORIES (SWEDEN) AB Limhamn SE	100011740;100020303	CEP 2019-316 - Rev 01	2026/05/04	Valid		Chemical	2026/05/04	Renewal\|CEP granted\|04/05/2026; Minor revision\|Accepted - CEP remains valid\|09/11/2021
931	Metformin Hydrochloride	IOL CHEMICALS AND PHARMACEUTICALS LIMITED Ludhiana IN	100017919;100037377	CEP 2013-188 - Rev 02	2026/05/04	Valid		Chemical	2026/05/04	Minor revision\|CEP granted\|04/05/2026; Minor revision\|CEP granted\|03/11/2022; Notification\|Accepted - CEP remains valid\|22/10/2020
2230	Latanoprost	MSN LABORATORIES PRIVATE LIMITED Sangareddy IN	100011732;100023530	CEP 2023-113 - Rev 01	2026/05/04	Valid	12/06/2029	Chemical	2026/05/04	Minor revision\|CEP granted\|04/05/2026; New application\|CEP granted\|12/06/2024
92	Indometacin	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2022-003 - Rev 01	2026/05/04	Valid	31/03/2028	Chemical	2026/05/04	Minor revision\|CEP granted\|04/05/2026; Minor revision\|Accepted - CEP remains valid\|08/07/2024; New application\|CEP granted\|31/03/2023
2443	Fulvestrant	CHONGQING HUAPONT SHENGCHEM PHARMACEUTICAL CO., LTD. Chongqing CN	100024073;100062002	CEP 2025-060 - Rev 00	2026/05/04	Valid	04/05/2031	Chemical	2026/05/04	New application\|CEP granted\|04/05/2026
1048	Testosterone enantate	SYMBIOTEC PHARMALAB LIMITED Indore IN	100018972;100095999	CEP 2025-080 - Rev 00	2026/05/04	Valid	04/05/2031	Chemical	2026/05/04	New application\|CEP granted\|04/05/2026
3132	Mirabegron	SYNTHIMED LABS PRIVATE LIMITED Derabassi IN	100052287;100092080	CEP 2025-017 - Rev 00	2026/05/04	Valid	04/05/2031	Chemical	2026/05/04	New application\|CEP granted\|04/05/2026
1472	Sodium hyaluronate, Intrinsic viscosity 3.0 m3/kg, by fermentation, for parenteral administration including intra-articular administration and for intra-ocular use	SHANDONG FOCUSFREDA BIOTECH CO., LTD. Qufu CN	100053560;100094671	CEP 2025-464 - Rev 00	2026/05/04	Valid	04/05/2031	Chemical	2026/05/04	New application\|CEP granted\|04/05/2026
2570	Desloratadine	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2016-065 - Rev 02	2026/04/30	Valid		Chemical	2026/04/30	Minor revision\|CEP granted\|30/04/2026; Minor revision\|CEP granted\|20/03/2024; Renewal\|CEP granted\|20/06/2022
2416	Pramipexole dihydrochloride monohydrate	ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN	100006039;100002980	CEP 2011-190 - Rev 01	2026/04/30	Valid		Chemical	2026/04/30	Minor revision\|CEP granted\|30/04/2026; Minor revision\|Accepted - CEP remains valid\|27/09/2024; Minor revision\|Accepted - CEP remains valid\|26/01/2024; Minor revision\|Accepted - CEP remains valid\|03/01/2023; Minor revision\|Accepted - CEP remains valid\|12/07/2022
2815	Entecavir monohydrate	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2017-271 - Rev 06	2026/04/30	Valid		Chemical	2026/04/30	Minor revision\|CEP granted\|30/04/2026; Notification\|CEP granted\|19/05/2025; Renewal\|CEP granted\|10/06/2024; Minor revision\|CEP granted\|28/07/2023; Minor revision\|CEP granted\|22/09/2020
2600	Olmesartan medoxomil	CHIERON ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN	100053345;100094249	CEP 2018-232 - Rev 03	2026/04/30	Valid		Chemical	2026/04/30	Major revision\|CEP granted\|30/04/2026; Renewal\|CEP granted\|11/07/2025; Minor revision\|Accepted - CEP remains valid\|20/09/2022; Major revision\|CEP granted\|08/07/2021; Minor revision\|Rejected\|22/02/2021
1773	Cabergoline	LIFECARE LABORATORIES PRIVATE LIMITED Hyderabad IN	100049798;100086853	CEP 2023-093 - Rev 01	2026/04/30	Valid	12/03/2031	Chemical	2026/04/30	Minor revision\|CEP granted\|30/04/2026; New application\|CEP granted\|12/03/2026
943	Oxymetazoline hydrochloride	COHANCE LIFESCIENCES LIMITED Mumbai IN	100011755;100090273	CEP 2025-091 - Rev 00	2026/04/30	Valid	30/04/2031	Chemical	2026/04/30	New application\|CEP granted\|30/04/2026
1974	Clobazam, Micronised	LAKE CHEMICALS PRIVATE LIMITED Bengaluru IN	100012055;100053935	CEP 2024-173 - Rev 00	2026/04/30	Valid	30/04/2031	Chemical	2026/04/30	New application\|CEP granted\|30/04/2026

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)	-