欧洲药典适用性证书数据库
(Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM)
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 证书结束日期 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, Process II MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2019-142 - Rev 02 2025/09/16 Valid 15/09/2026 Chemical 2025/09/16 Notification|CEP granted|16/09/2025;
Notification|CEP granted|22/07/2024
2296 Pantoprazole sodium sesquihydrate Ulkar Kimya Sanayii Ve Ticaret Anonim Sirketi Istanbul TR 100022492;100082995 CEP 2024-048 - Rev 00 2025/09/15 Valid 15/09/2030 Chemical 2025/09/15 New application|CEP granted|15/09/2025
1425 Fosfomycin trometamol CLAROCHEM IRELAND LTD. Dublin 15 IE 100016003;100024745 CEP 2022-327 - Rev 01 2025/09/15 Valid 17/05/2028 Chemical 2025/09/15 Minor revision|CEP granted|15/09/2025;
New application|CEP granted|17/05/2023
811 Betamethasone valerate AURISCO PHARMACEUTICAL CO., LTD. Tiantai CN 100011968;100018590 CEP 2021-120 - Rev 02 2025/09/15 Valid 31/05/2027 Chemical 2025/09/15 Minor revision|CEP granted|15/09/2025;
Minor revision|CEP granted|14/09/2022;
New application|CEP granted|31/05/2022
2531 Clopidogrel hydrogen sulfate, Form II, AS MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2025-295 - Rev 01 2025/09/15 Valid 28/08/2030 Chemical 2025/09/15 Notification|CEP granted|15/09/2025;
New application|CEP granted|28/08/2025
1029 Mexiletine hydrochloride HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2021-421 - Rev 01 2025/09/15 Valid 10/03/2028 Chemical 2025/09/15 Minor revision|CEP granted|15/09/2025;
Minor revision|Accepted - CEP remains valid|05/09/2024;
New application|CEP granted|10/03/2023
1711 Buspirone hydrochloride ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2024-108 - Rev 00 2025/09/15 Valid 15/09/2030 Chemical 2025/09/15 New application|CEP granted|15/09/2025
1649 Azithromycin, Dihydrate SHANDONG ANXIN PHARMACEUTICAL CO., LTD Jinan CN 100012114;100052387 CEP 2025-033 - Rev 00 2025/09/15 Valid 15/09/2030 Chemical 2025/09/15 New application|CEP granted|15/09/2025
2255 Nevirapine MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2011-075 - Rev 06 2025/09/15 Valid Chemical 2025/09/15 Notification|CEP granted|15/09/2025;
Notification|CEP granted|18/07/2024;
Minor revision|CEP granted|19/12/2023;
Notification|CEP granted|31/08/2021
2615 Lopinavir MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2013-011 - Rev 04 2025/09/15 Valid Chemical 2025/09/15 Notification|CEP granted|15/09/2025;
Notification|CEP granted|23/07/2024;
Major revision|CEP granted|31/01/2024;
Minor revision|CEP granted|30/08/2021
2254 Moxifloxacin hydrochloride MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2013-201 - Rev 04 2025/09/15 Valid Chemical 2025/09/15 Notification|CEP granted|15/09/2025;
Minor revision|CEP granted|19/07/2024;
Minor revision|CEP granted|25/10/2023;
Notification|CEP granted|31/08/2021;
Renewal|CEP granted|02/09/2020
2124 Loratadine MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2007-171 - Rev 06 2025/09/15 Valid Chemical 2025/09/15 Notification|CEP granted|15/09/2025;
Notification|CEP granted|11/07/2024;
Minor revision|CEP granted|07/03/2024;
Minor revision|CEP granted|24/01/2023
2640 Atomoxetine hydrochloride MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2013-271 - Rev 04 2025/09/15 Valid Chemical 2025/09/15 Notification|CEP granted|15/09/2025;
Minor revision|CEP granted|05/02/2025;
Notification|CEP granted|22/07/2024;
Notification|CEP granted|31/08/2021
737 Hyoscine butylbromide ALKALOIDS PRIVATE LIMITED Secunderabad IN 100021602;100041426 CEP 2002-158 - Rev 06 2025/09/12 Valid Chemical 2025/09/12 Minor revision|CEP granted|12/09/2025;
Transfer of holdership|CEP granted|11/12/2023;
Notification|CEP granted|19/02/2021
1702 Naproxen sodium ZHEJIANG CHARIOTEER PHARMACEUTICAL CO., LTD Xianju CN 100011826;100018693 CEP 2010-021 - Rev 03 2025/09/12 Valid Chemical 2025/09/12 Administrative procedure|CEP granted|12/09/2025;
Minor revision|CEP granted|04/09/2025;
Notification|Accepted - CEP remains valid|10/11/2023;
Notification|Accepted - CEP remains valid|05/01/2022
1691 Dacarbazine VUAB PHARMA A.S. Roztoky CZ 100000440;100007827 CEP 2012-330 - Rev 03 2025/09/12 Valid Chemical 2025/09/12 Notification|CEP granted|12/09/2025;
Notification|Accepted - CEP remains valid|05/07/2023;
Notification|CEP granted|26/05/2023;
Monograph revision|Accepted - CEP remains valid|21/07/2021;
Minor revision|CEP granted|26/02/2021;
Notification|Rejected|18/12/2020
2585 Rizatriptan benzoate APOTEX PHARMACHEM INDIA PRIVATE LIMITED Bangalore IN 100012611;100041734 CEP 2013-206 - Rev 01 2025/09/12 Valid Chemical 2025/09/12 Minor revision|CEP granted|12/09/2025;
Renewal|CEP granted|30/11/2020
333 Heparin sodium HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO., LTD. Shijiazhuang CN 100016151;100061309 CEP 2005-270 - Rev 13 2025/09/12 Valid Chemical 2026/01/21 Monograph revision|Accepted - CEP remains valid|21/01/2026;
Major revision|CEP granted|12/09/2025;
Monograph revision|Accepted - CEP remains valid|18/06/2024;
Minor revision|CEP granted|01/03/2024;
Minor revision|CEP granted|21/09/2022;
Major revision|CEP granted|02/11/2021;
Minor revision|CEP granted|06/10/2020;
Notification|CEP granted|24/03/2020
1733 Piracetam NORTHEAST PHARMACEUTICAL GROUP CO. LTD Shenyang CN 100021339;100054155 CEP 2004-083 - Rev 08 2025/09/12 Valid Chemical 2025/09/12 Minor revision|CEP granted|12/09/2025;
Minor revision|Accepted - CEP remains valid|03/08/2023;
Minor revision|Accepted - CEP remains valid|14/09/2021;
Administrative procedure|CEP granted|21/04/2021;
Monograph revision|Accepted - CEP remains valid|30/03/2021;
Minor revision|CEP granted|25/11/2020;
Minor revision|Accepted - CEP remains valid|23/06/2020
1362 Prilocaine SWATI SPENTOSE PRIVATE LIMITED Mumbai IN 100021605;100052219 CEP 2020-347 - Rev 02 2025/09/12 Valid 09/12/2027 Chemical 2025/09/12 Minor revision|CEP granted|12/09/2025;
Notification|CEP granted|16/09/2024;
New application|CEP granted|09/12/2022

数据库说明:

当前数据更新日期:2026年02月10日。
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