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
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
1473 Soya-bean oil, refined, IV SOCIETE INDUSTRIELLE DES OLEAGINEUX SIO Saint-Laurent Blangy FR 100018152;100094230 CEP 2011-115 - Rev 03 2025/01/16 Valid Chemical 2025/01/16 Notification|CEP granted|16/01/2025;
Minor revision|Accepted - CEP remains valid|26/08/2024;
Minor revision|CEP granted|27/11/2023;
Minor revision|Accepted - CEP remains valid|15/09/2021
1473 Soya-bean oil, refined, BXR EU, antioxidant ascorbyl palmitate SOCIETE INDUSTRIELLE DES OLEAGINEUX SIO Saint-Laurent Blangy FR 100018152;100094230 CEP 2012-336 - Rev 02 2025/01/16 Valid Chemical 2025/01/16 Notification|CEP granted|16/01/2025;
Minor revision|Accepted - CEP remains valid|26/08/2024;
Minor revision|Accepted - CEP remains valid|09/03/2022;
Major revision|CEP granted|15/09/2020
1559 Risperidone TORRENT PHARMACEUTICALS LIMITED Ahmedabad IN 100004452;100001862 CEP 2004-160 - Rev 04 2025/01/15 Valid Chemical 2025/01/15 Minor revision|CEP granted|15/01/2025;
Minor revision|CEP granted|27/10/2023;
Notification|CEP granted|27/05/2020
1451 Mupirocin calcium, Micronised HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO., LTD. Hangzhou CN 100016034;100024777 CEP 2013-236 - Rev 04 2025/01/15 Valid Chemical 2025/01/15 Minor revision|CEP granted|15/01/2025;
Administrative procedure|CEP granted|04/01/2022;
Minor revision|CEP granted|17/12/2021;
Minor revision|CEP granted|24/06/2021;
Minor revision|Accepted - CEP remains valid|17/08/2020
1065 Alprazolam FERMION OY Espoo FI 100011508;100020280 CEP 2007-365 - Rev 02 2025/01/15 Valid Chemical 2025/01/15 Minor revision|CEP granted|15/01/2025;
Minor revision|Accepted - CEP remains valid|17/10/2022
888 Ciprofloxacin Hydrochloride AARTI DRUGS LIMITED Mumbai IN 100014953;100023652 CEP 2005-119 - Rev 06 2025/01/15 Valid Chemical 2025/01/15 Minor revision|CEP granted|15/01/2025;
Minor revision|CEP granted|21/08/2024
2177 Lufenuron for veterinary use ALIVIRA ANIMAL HEALTH LIMITED Visakhapatnam IN 100033528;100052489 CEP 2023-125 - Rev 00 2025/01/15 Valid 15/01/2030 Chemical 2025/01/15 New application|CEP granted|15/01/2025
2757 Aprepitant, Form I SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN 100032307;100078783 CEP 2022-033 - Rev 00 2025/01/15 Valid 15/01/2030 Chemical 2025/01/15 New application|CEP granted|15/01/2025
615 Guaifenesin, Unit-II SYNTHOKEM LABS PRIVATE LIMITED Hyderabad IN 100018775;100027570 CEP 2019-065 - Rev 01 2025/01/15 Valid Chemical 2025/01/15 Renewal|CEP granted|15/01/2025;
Minor revision|Accepted - CEP remains valid|30/05/2022;
Notification|Rejected|10/11/2021
312 Betamethasone AURISCO PHARMACEUTICAL CO., LTD. Tiantai CN 100011968;100018590 CEP 2022-196 - Rev 02 2025/01/15 Valid 13/11/2029 Chemical 2025/01/15 Administrative procedure|CEP granted|15/01/2025;
Minor revision|CEP granted|19/12/2024;
New application|CEP granted|13/11/2024
2815 Entecavir monohydrate DONG BANG FUTURE TECH & LIFE CO., LTD. Hwaseong-si KR 100024414;100042624 CEP 2018-093 - Rev 01 2025/01/15 Valid Chemical 2025/01/15 Renewal|CEP granted|15/01/2025
2235 Methylphenidate hydrochloride, Process II HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2021-474 - Rev 01 2025/01/15 Valid 25/05/2027 Chemical 2025/01/15 Minor revision|CEP granted|15/01/2025;
New application|CEP granted|25/05/2022
2765 Eplerenone, Process code - EPLB, Micronised (FA, FC) AURISCO PHARMACEUTICAL CO., LTD. Tiantai CN 100011968;100018590 CEP 2019-028 - Rev 02 2025/01/14 Valid Chemical 2025/01/14 Renewal|CEP granted|14/01/2025;
Notification|Accepted - CEP remains valid|22/11/2022;
Minor revision|Accepted - CEP remains valid|21/09/2021;
Notification|Accepted - CEP remains valid|07/12/2020;
Minor revision|CEP granted|26/10/2020

数据库说明:

当前数据更新日期:2025年12月05日。
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