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
934 Metronidazole benzoate ACHARYA CHEMICALS Dombivli (East) IN 100023843;100094052 CEP 2007-056 - Rev 04 2025/01/20 Valid Chemical 2025/01/20 Minor revision|CEP granted|20/01/2025;
Notification|Rejected|10/12/2024;
Administrative procedure|CEP granted|05/04/2023
2777 Pregabalin SRINI PHARMACEUTICALS PRIVATE LIMITED Choutuppal IN 100018880;100027661 CEP 2018-169 - Rev 01 2025/01/20 Valid Chemical 2025/01/20 Renewal|CEP granted|20/01/2025
1191 Clozapine AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100046306;100076393 CEP 2021-110 - Rev 01 2025/01/20 Valid 08/07/2027 Chemical 2025/06/13 Minor revision|Accepted - CEP remains valid|13/06/2025;
Minor revision|CEP granted|20/01/2025;
New application|CEP granted|08/07/2022
1745 Carvedilol CTX LIFESCIENCES PVT. LIMITED Surat IN 100019102;100027863 CEP 2014-201 - Rev 02 2025/01/20 Valid Chemical 2025/01/20 Minor revision|CEP granted|20/01/2025;
Minor revision|CEP granted|05/04/2022;
Renewal|CEP granted|18/06/2021
2335 Ropivacaine hydrochloride monohydrate SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO., LTD. Dezhou City CN 100048410;100080174 CEP 2023-148 - Rev 01 2025/01/20 Valid 25/09/2029 Chemical 2025/01/20 Minor revision|CEP granted|20/01/2025;
New application|CEP granted|25/09/2024
752 Alanine AMINO GMBH Frellstedt DE 100011599;100021107 CEP 2013-157 - Rev 02 2025/01/20 Valid Chemical 2025/01/20 Notification|CEP granted|20/01/2025;
Minor revision|CEP granted|31/05/2023
1188 Cefixime PURE AND CURE HEALTHCARE PRIVATE LIMITED Punjab IN 100045639;100075200 CEP 2009-005 - Rev 02 2025/01/20 Valid Chemical 2025/01/20 Notification|CEP granted|20/01/2025;
Transfer of holdership|CEP granted|13/01/2022
578 Ampicillin sodium, Sterile, Enzymatic route SANDOZ GMBH Kundl AT 100000546;100000450 CEP 2024-480 - Rev 00 2025/01/20 Valid 20/01/2030 Chemical 2025/01/20 New application|CEP granted|20/01/2025
1089 Ciprofloxacin ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shaoxing CN 100022562;100093113 CEP 2020-120 - Rev 03 2025/01/17 Valid 11/06/2026 Chemical 2025/01/17 Minor revision|CEP granted|17/01/2025;
Minor revision|CEP granted|03/07/2024;
Minor revision|CEP granted|26/10/2022;
New application|CEP granted|11/06/2021
2232 Losartan potassium SYNERGENE ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN 100038855;100091886 CEP 2023-049 - Rev 00 2025/01/17 Valid 17/01/2030 Chemical 2025/01/17 New application|CEP granted|17/01/2025
1456 Olive oil, refined, BXR EU refined olive oil SOCIETE INDUSTRIELLE DES OLEAGINEUX SIO Saint-Laurent Blangy FR 100018152;100094230 CEP 2012-333 - Rev 01 2025/01/17 Valid Chemical 2025/10/30 Minor revision|Accepted - CEP remains valid|30/10/2025;
Notification|CEP granted|17/01/2025;
Minor revision|Accepted - CEP remains valid|27/08/2024;
Minor revision|Accepted - CEP remains valid|09/03/2022;
Minor revision|Accepted - CEP remains valid|06/07/2020
335 Hydrocortisone, Non-micronised, micronised SHANDONG XINHUA PHARMACEUTICAL CO., LTD. Zibo CN 100011788;100019607 CEP 2019-176 - Rev 01 2025/01/17 Valid 06/10/2026 Chemical 2025/01/17 Minor revision|CEP granted|17/01/2025;
Notification|Accepted - CEP remains valid|24/06/2024
2702 Chlormadinone acetate, Micronised (grade 21), non-micronised FARMABIOS S.p.A Gropello Cairoli IT 100011643;100021232 CEP 2018-122 - Rev 04 2025/01/17 Valid Chemical 2025/01/17 Renewal|CEP granted|17/01/2025;
Minor revision|CEP granted|07/09/2023;
Minor revision|CEP granted|18/12/2020;
Minor revision|CEP granted|13/05/2020
1286 Alfacalcidol TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2000-100 - Rev 07 2025/01/17 Valid Chemical 2025/01/17 Administrative procedure|CEP granted|17/01/2025;
Notification|CEP granted|13/01/2025;
Notification|Accepted - CEP remains valid|22/02/2024;
Notification|Accepted - CEP remains valid|05/08/2022;
Notification|CEP granted|20/12/2021;
Minor revision|CEP granted|26/05/2021
711 Cyclophosphamide monohydrate, Milled and non milled MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN 100011732;100023530 CEP 2018-092 - Rev 02 2025/01/17 Valid Chemical 2025/01/17 Renewal|CEP granted|17/01/2025;
Monograph revision|CEP granted|23/08/2023
1699 Mesalazine IOL CHEMICALS AND PHARMACEUTICALS LTD Ludhiana IN 100017919;100037377 CEP 2023-339 - Rev 00 2025/01/16 Valid 16/01/2030 Chemical 2025/01/16 New application|CEP granted|16/01/2025
198 Oxytetracycline hydrochloride INNER MONGOLIA GLINT PHARMACEUTICAL CO., LTD. Chifeng CN 100039247;100061785 CEP 2021-412 - Rev 02 2025/01/16 Valid 12/12/2027 Chemical 2025/01/16 Monograph revision|CEP granted|16/01/2025;
Minor revision|CEP granted|06/04/2023;
New application|CEP granted|12/12/2022
2675 Irinotecan hydrochloride trihydrate, Process 2, Form b SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN 100044578;100073706 CEP 2019-156 - Rev 02 2025/01/16 Valid Chemical 2025/01/16 Renewal|CEP granted|16/01/2025;
Notification|CEP granted|21/07/2022
23 Diphenhydramine hydrochloride QIDONG DONGYUE PHARMACEUTICAL CO., LTD. Qidong CN 100012994;100023425 CEP 2023-023 - Rev 00 2025/01/16 Valid 16/01/2030 Chemical 2025/01/16 New application|CEP granted|16/01/2025
1456 Olive oil, refined, For parenteral use SOCIETE INDUSTRIELLE DES OLEAGINEUX SIO Saint-Laurent Blangy FR 100018152;100094230 CEP 2015-167 - Rev 02 2025/01/16 Valid Chemical 2025/01/16 Notification|CEP granted|16/01/2025;
Minor revision|CEP granted|06/02/2024;
Minor revision|Accepted - CEP remains valid|16/03/2022;
Renewal|CEP granted|24/08/2020

数据库说明:

当前数据更新日期:2025年12月10日。
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