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
1575 Tiapride hydrochloride, Process 2 OLON S.P.A. Rodano IT 100012085;100019537 CEP 2014-274 - Rev 01 2025/02/13 Valid Chemical 2025/02/13 Notification|CEP granted|13/02/2025;
Minor revision|Accepted - CEP remains valid|28/05/2024;
Minor revision|Accepted - CEP remains valid|13/02/2023
1354 Oxybutynin hydrochloride OLON S.P.A. Rodano IT 100012085;100019537 CEP 2019-350 - Rev 01 2025/02/13 Valid 08/11/2027 Chemical 2025/02/13 Notification|CEP granted|13/02/2025
2531 Clopidogrel hydrogen sulfate, Form-II, milled and non-milled MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN 100018316;100070723 CEP 2019-318 - Rev 01 2025/02/13 Valid Chemical 2025/02/13 Renewal|CEP granted|13/02/2025
1524 Gliclazide, AP BAL PHARMA LIMITED Bengaluru IN 100016398;100041736 CEP 2013-039 - Rev 01 2025/02/13 Valid Chemical 2025/02/13 Minor revision|CEP granted|13/02/2025;
Renewal|CEP granted|27/08/2020
23 Diphenhydramine hydrochloride SUPRIYA LIFESCIENCE LIMITED Mumbai IN 100015796;100024574 CEP 2019-120 - Rev 01 2025/02/13 Valid 27/09/2027 Chemical 2025/02/13 Minor revision|CEP granted|13/02/2025
2736 Imatinib mesilate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2015-096 - Rev 05 2025/02/13 Valid Chemical 2025/02/13 Administrative procedure|CEP granted|13/02/2025;
Minor revision|CEP granted|03/01/2025;
Notification|CEP granted|19/07/2023;
Notification|Accepted - CEP remains valid|22/11/2022;
Administrative procedure|CEP granted|02/12/2021;
Notification|CEP granted|22/11/2021;
Minor revision|Accepted - CEP remains valid|17/09/2021;
Renewal|CEP granted|24/06/2021;
Minor revision|Accepted - CEP remains valid|30/06/2020
485 Dihydrostreptomycin sulfate for veterinary use North China Pharmaceutical Huasheng Co., Ltd. Shijiazhuang CN 100021261;100029965 CEP 2001-393 - Rev 07 2025/02/13 Valid Chemical 2025/02/13 Minor revision|CEP granted|13/02/2025;
Minor revision|CEP granted|28/06/2023;
Minor revision|Accepted - CEP remains valid|13/01/2021
1272 Tryptophan Ajinomoto Co., Inc. Tokyo JP 100011941;100021464 CEP 1998-137 - Rev 07 2025/02/12 Valid Chemical 2025/02/13 Notification|CEP granted|13/02/2025;
Notification|CEP granted|12/02/2024;
Notification|CEP granted|31/03/2023
1146 Roxithromycin ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 1999-029 - Rev 10 2025/02/12 Valid Chemical 2025/02/13 Minor revision|CEP granted|13/02/2025;
Minor revision|Accepted - CEP remains valid|23/11/2020
1137 Pentamidine diisetionate EMCURE PHARMACEUTICALS LIMITED Pune IN 100011677;100022690 CEP 2022-169 - Rev 01 2025/02/12 Valid 10/03/2028 Chemical 2025/02/12 Notification|CEP granted|12/02/2025;
New application|CEP granted|10/03/2023
2631 Rosuvastatin calcium, AM code APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2024-400 - Rev 01 2025/02/12 Valid 14/01/2030 Chemical 2025/02/12 Administrative procedure|CEP granted|12/02/2025;
New application|CEP granted|14/01/2025
1711 Buspirone hydrochloride MAITHRI LABORATORIES PRIVATE LIMITED Gaddapotharam Village IN 100013041;100021615 CEP 2023-395 - Rev 00 2025/02/12 Valid 12/02/2030 Chemical 2025/02/12 New application|CEP granted|12/02/2025
1045 Sulpiride OLON S.P.A. Rodano IT 100012085;100019537 CEP 1998-073 - Rev 10 2025/02/12 Valid Chemical 2025/02/12 Notification|CEP granted|12/02/2025;
Minor revision|Accepted - CEP remains valid|28/06/2024;
Minor revision|Accepted - CEP remains valid|26/08/2022;
Minor revision|CEP granted|27/04/2021
1564 Sodium alendronate trihydrate APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2007-048 - Rev 03 2025/02/12 Valid Chemical 2025/02/12 Minor revision|CEP granted|12/02/2025;
Notification|CEP granted|11/01/2024;
Minor revision|Accepted - CEP remains valid|31/07/2023;
Minor revision|Accepted - CEP remains valid|25/05/2022
330 Gelatin, Acid bone gelatin TESSENDERLO GROUP N.V. Vilvoorde BE 100038809;100060926 CEP 2008-187 - Rev 01 2025/02/12 Valid TSE 2025/02/12 Major revision|CEP granted|12/02/2025
3078 Riociguat, Modification I, micronised ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2023-191 - Rev 00 2025/02/11 Valid 11/02/2030 Chemical 2025/02/11 New application|CEP granted|11/02/2025
2631 Rosuvastatin calcium, ZH code APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2024-407 - Rev 00 2025/02/11 Valid 11/02/2030 Chemical 2025/02/11 New application|CEP granted|11/02/2025
1750 Fluticasone propionate CURIA SPAIN S.A.U. Boecillo ES 100011649;100019586 CEP 2013-315 - Rev 02 2025/02/11 Valid Chemical 2025/02/11 Minor revision|CEP granted|11/02/2025;
Notification|CEP granted|25/08/2021;
Monograph revision|Accepted - CEP remains valid|20/04/2021
931 Metformin Hydrochloride ABHILASHA PHARMA PRIVATE LIMITED Ankleshwar IN 100050097;100087479 CEP 2024-016 - Rev 00 2025/02/11 Valid 11/02/2030 Chemical 2025/02/11 New application|CEP granted|11/02/2025
2637 Pemetrexed disodium heptahydrate SHIVALIK RASAYAN LIMITED Bharuch IN 100048259;100079859 CEP 2023-301 - Rev 00 2025/02/11 Valid 11/02/2030 Chemical 2025/02/11 New application|CEP granted|11/02/2025

数据库说明:

当前数据更新日期:2025年02月18日。
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