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
1765 Salmeterol xinafoate, Micronised, grades I and II CIPLA LIMITED Mumbai IN 100006004;100018147 CEP 2006-296 - Rev 06 2026/01/13 Valid Chemical 2026/01/13 Minor revision|CEP granted|13/01/2026;
Notification|CEP granted|12/04/2022
1275 Ursodeoxycholic acid, UDCAe "c" PharmaZell GmbH Raubling DE 100012552;100021381 CEP 2018-115 - Rev 02 2026/01/13 Valid Chemical and TSE 2026/01/13 Monograph revision|CEP granted|13/01/2026;
Minor revision|CEP granted|17/06/2024;
Renewal|CEP granted|10/08/2023;
Minor revision|CEP granted|19/09/2022;
Minor revision|Accepted - CEP remains valid|17/02/2022
1593 Megestrol acetate, Micronised and fine powder FARMABIOS S.p.A Gropello Cairoli IT 100011643;100021232 CEP 2002-181 - Rev 10 2026/01/13 Valid Chemical 2026/01/13 Minor revision|CEP granted|13/01/2026;
Minor revision|Accepted - CEP remains valid|30/08/2024;
Minor revision|CEP granted|30/05/2024;
Administrative procedure|CEP granted|05/05/2022;
Minor revision|CEP granted|14/04/2022;
Minor revision|CEP granted|16/10/2020
1444 Macrogols, Type 300, 400, 600, 1000, 1500, 3000, 3350, 4000 and 6000 CLARIANT PRODUKTE (DEUTSCHLAND) GMBH Frankfurt am Main DE 100016585;100056036 CEP 2002-180 - Rev 07 2026/01/13 Valid Chemical 2026/01/13 Minor revision|CEP granted|13/01/2026;
Notification|CEP granted|04/11/2024;
Minor revision|CEP granted|27/11/2023;
Minor revision|CEP granted|23/11/2020
2856 Pirfenidone JUBILANT BIOSYS LIMITED Mysuru IN 100055198;100098088 CEP 2018-091 - Rev 04 2026/01/13 Valid Chemical 2026/01/13 Notification|CEP granted|13/01/2026;
Renewal|CEP granted|20/08/2024;
Notification|CEP granted|23/08/2022
2600 Olmesartan medoxomil JUBILANT BIOSYS LIMITED Mysuru IN 100055198;100098088 CEP 2013-325 - Rev 02 2026/01/13 Valid Chemical 2026/01/13 Notification|CEP granted|13/01/2026;
Notification|CEP granted|12/08/2022;
Renewal|CEP granted|18/12/2020
573 Verapamil hydrochloride ASSURGEN PHARMA PRIVATE LIMITED Visakhapatnam IN 100048048;100079469 CEP 2019-014 - Rev 02 2026/01/13 Valid Chemical 2026/01/13 Renewal|CEP granted|13/01/2026;
Minor revision|CEP granted|20/02/2023
1491 Amlodipine besilate, Site Khazipally AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100046306;100076393 CEP 2023-064 - Rev 01 2026/01/13 Valid 31/05/2028 Chemical 2026/01/13 Monograph revision|CEP granted|13/01/2026;
New application|CEP granted|31/05/2023
2992 Lacosamide JUBILANT BIOSYS LIMITED Mysuru IN 100055198;100098088 CEP 2019-049 - Rev 02 2026/01/13 Valid 21/12/2025 Chemical 2026/01/13 Notification|CEP granted|13/01/2026;
Notification|CEP granted|12/08/2022
1458 Oxfendazole For Veterinary Use, Process II ALIVIRA ANIMAL HEALTH LIMITED Visakhapatnam IN 100033528;100052489 CEP 2021-071 - Rev 03 2026/01/13 Valid Chemical 2026/01/13 Renewal|CEP granted|13/01/2026;
Notification|CEP granted|18/04/2023;
Minor revision|CEP granted|20/10/2021;
New application|CEP granted|31/03/2021
1491 Amlodipine besilate AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100046306;100076393 CEP 2019-310 - Rev 02 2026/01/13 Valid 16/08/2026 Chemical 2026/01/13 Monograph revision|CEP granted|13/01/2026;
Minor revision|CEP granted|15/11/2024
2898 Atazanavir sulfate, Micronised and non-micronised, form A GRANULES INDIA LIMITED Hyderabad IN 100011671;100097387 CEP 2020-279 - Rev 02 2026/01/13 Valid 20/06/2027 Chemical 2026/01/13 Minor revision|CEP granted|13/01/2026;
Notification|CEP granted|10/06/2024;
New application|CEP granted|20/06/2022
1573 Sumatriptan succinate, Process II DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2023-022 - Rev 01 2026/01/12 Valid 30/10/2028 Chemical 2026/01/12 Minor revision|CEP granted|12/01/2026;
New application|CEP granted|30/10/2023
821 Estradiol hemihydrate SCHMITT PHARMA GMBH Kleinmachnow DE 100048120;100079611 CEP 2025-211 - Rev 00 2026/01/12 Valid 12/01/2031 Chemical 2026/01/12 New application|CEP granted|12/01/2026
248 Suxamethonium Chloride SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN 100032307;100099917 CEP 2013-210 - Rev 02 2026/01/12 Valid Chemical 2026/01/12 Notification|CEP granted|12/01/2026;
Minor revision|CEP granted|30/05/2024;
Renewal|CEP granted|15/02/2021
768 Hydrocortisone hydrogen succinate SYMBIOTEC PHARMALAB PRIVATE LIMITED Indore IN 100018972;100095999 CEP 2014-120 - Rev 02 2026/01/12 Valid Chemical 2026/01/12 Notification|CEP granted|12/01/2026;
Minor revision|Accepted - CEP remains valid|07/07/2023;
Minor revision|CEP granted|19/08/2021;
Renewal|CEP granted|18/02/2021
1756 Lamotrigine, Anhydrous Form ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2018-295 - Rev 04 2026/01/12 Valid Chemical 2026/01/12 Renewal|CEP granted|12/01/2026;
Minor revision|CEP granted|30/01/2024;
Minor revision|Accepted - CEP remains valid|24/04/2023;
Minor revision|CEP granted|02/12/2022;
Notification|CEP granted|08/07/2022
2411 Epinastine hydrochloride WUHAN CALMLAND PHARMACEUTICALS CO., LTD. Wuhan CN 100049301;100083738 CEP 2024-295 - Rev 00 2026/01/12 Valid 12/01/2031 Chemical 2026/01/12 New application|CEP granted|12/01/2026
2063 Omega-3-acid ethyl esters 60, Containing mixed tocopherols K.D. PHARMA BEXBACH GMBH Bexbach DE 100016421;100092038 CEP 2009-326 - Rev 02 2026/01/08 Valid Chemical 2026/01/08 Minor revision|CEP granted|08/01/2026
67 Folic acid hydrate DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 1996-045 - Rev 08 2026/01/08 Valid Chemical 2026/01/08 Minor revision|CEP granted|08/01/2026;
Notification|CEP granted|17/07/2025;
Administrative procedure|CEP granted|10/08/2023;
Minor revision|CEP granted|06/07/2023;
Monograph revision|Accepted - CEP remains valid|11/05/2022;
Minor revision|CEP granted|27/04/2021

数据库说明:

当前数据更新日期:2026年04月04日。
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