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
1724 Formoterol fumarate dihydrate Vamsi Labs Limited Solapur IN 100014747;100023262 R1-CEP 2006-227 - Rev 02 2022/07/28 Valid Chemical 2023/09/22 Notification|Accepted - CEP remains valid|22/09/2023;
Notification|CEP granted|28/07/2022;
Monograph revision|Accepted - CEP remains valid|06/05/2022
1745 Carvedilol SHODHANA LABORATORIES PRIVATE LIMITED Hyderabad IN 100021550;100030244 R1-CEP 2008-259 - Rev 01 2022/07/28 Valid Chemical 2022/07/28 Minor revision|CEP granted|28/07/2022
2420 Tiotropium bromide monohydrate, Micronised, non-micronised Vamsi Labs Limited Solapur IN 100014747;100023262 R1-CEP 2012-285 - Rev 01 2022/07/28 Valid Chemical 2023/09/14 Notification|Rejected|14/09/2023;
Notification|CEP granted|28/07/2022
2307 Modafinil WAVELENGTH ENTERPRISES LTD. Petah Tikva IL 100018877;100050444 R1-CEP 2013-213 - Rev 03 2022/07/28 Valid Chemical 2022/12/21 Minor revision|Accepted - CEP remains valid|21/12/2022;
Minor revision|CEP granted|28/07/2022;
Minor revision|CEP granted|02/11/2021;
Notification|CEP granted|10/06/2020
1558 Propofol HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 R1-CEP 2015-347 - Rev 00 2022/07/28 Valid Chemical 2022/07/28 Renewal|CEP granted|28/07/2022;
Minor revision|CEP granted|02/11/2020
394 Hydrochlorothiazide AMOLI ORGANICS PRIVATE LIMITED Mumbai IN 100016500;100025303 R1-CEP 2016-012 - Rev 00 2022/07/28 Valid Chemical 2022/07/28 Renewal|CEP granted|28/07/2022;
Minor revision|CEP granted|12/01/2021;
Minor revision|CEP granted|03/06/2020
2191 Atorvastatin calcium, Process-IV ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 R0-CEP 2021-079 - Rev 01 2022/07/27 Valid 05/07/2026 Chemical 2022/08/01 Monograph revision|CEP granted|01/08/2022;
New application|CEP granted|05/07/2021
703 Atenolol, ALA route KOPRAN RESEARCH LABORATORIES LIMITED Mumbai IN R0-CEP 2021-479 - Rev 00 2022/07/27 Valid 27/07/2027 Chemical 2022/07/27 New application|CEP granted|27/07/2022
2531 Clopidogrel hydrogen sulfate, Process II Zhejiang Charioteer Pharmaceutical Co., Ltd. Xianju CN R0-CEP 2022-063 - Rev 00 2022/07/27 Valid 27/07/2027 Chemical 2022/07/27 New application|CEP granted|27/07/2022
729 Naloxone hydrochloride dihydrate, Process-II SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538 R0-CEP 2022-118 - Rev 00 2022/07/27 Valid 27/07/2027 Chemical 2022/07/27 New application|CEP granted|27/07/2022
721 Ibuprofen IOL CHEMICALS AND PHARMACEUTICALS LTD Ludhiana IN 100017919;100037377 R1-CEP 2008-316 - Rev 05 2022/07/27 Valid Chemical 2022/07/27 Minor revision|CEP granted|27/07/2022;
Notification|CEP granted|21/06/2021
2404 Drospirenone, Micronised (micro 15) BAYER AG Leverkusen DE 100000011;100001505 R1-CEP 2009-070 - Rev 02 2022/07/27 Valid Chemical 2022/07/27 Minor revision|CEP granted|27/07/2022
1573 Sumatriptan succinate MSN PHARMACHEM PRIVATE LIMITED Pashamylaram Village IN 100014794 R1-CEP 2009-096 - Rev 03 2022/07/27 Valid Chemical 2022/07/27 Minor revision|CEP granted|27/07/2022;
Minor revision|CEP granted|11/03/2021
52 Rifampicin OLON S.P.A. Rodano IT 100012085;100019537 R1-CEP 2009-275 - Rev 04 2022/07/27 Valid Chemical 2022/07/27 Minor revision|CEP granted|27/07/2022;
Major revision|CEP granted|24/11/2021
2191 Atorvastatin calcium, Process II ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 R1-CEP 2011-156 - Rev 05 2022/07/27 Valid Chemical 2022/07/27 Monograph revision|CEP granted|27/07/2022;
Notification|CEP granted|08/07/2022;
Minor revision|Rejected|27/01/2021;
Major revision|CEP granted|31/03/2020
2760 Brimonidine tartrate Farmak A.S. Olomouc CZ 100012043;100022687 R1-CEP 2014-331 - Rev 01 2022/07/27 Valid Chemical 2022/07/27 Minor revision|CEP granted|27/07/2022;
Notification|Accepted - CEP remains valid|21/02/2022;
Renewal|CEP granted|05/07/2021
2541 Quetiapine Fumarate EGIS Pharmaceuticals PLC Budapest HU 100001091;100001662 R1-CEP 2016-049 - Rev 00 2022/07/27 Valid Chemical 2023/03/17 Notification|Accepted - CEP remains valid|17/03/2023;
Renewal|CEP granted|27/07/2022;
Notification|Accepted - CEP remains valid|10/12/2020
2191 Atorvastatin calcium, Process-III ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 R0-CEP 2020-309 - Rev 01 2022/07/26 Valid Chemical 2022/07/26 Monograph revision|CEP granted|26/07/2022;
New application|CEP granted|19/02/2021
39 Magnesium Hydroxide ANHUI POLY PHARM. CO., LTD. Anqing CN R0-CEP 2022-010 - Rev 00 2022/07/26 Valid 26/07/2027 Chemical 2022/07/26 New application|CEP granted|26/07/2022
662 Daunorubicin Hydrochloride TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL 100000702;100060842 R1-CEP 2001-284 - Rev 03 2022/07/26 Valid Chemical 2023/02/17 Monograph revision|Accepted - CEP remains valid|17/02/2023;
Minor revision|CEP granted|26/07/2022;
Notification|CEP granted|20/12/2021;
Notification|Accepted - CEP remains valid|26/06/2020

数据库说明:

当前数据更新日期:2023年10月05日。
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