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
3139 Brivaracetam, Non-micronised and micronised ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN 100011833;100018698 CEP 2024-064 - Rev 01 2025/12/04 Valid 25/02/2030 Chemical 2025/12/04 Minor revision|CEP granted|04/12/2025;
New application|CEP granted|25/02/2025
2296 Pantoprazole sodium sesquihydrate, Process III APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2024-346 - Rev 00 2025/12/04 Valid 04/12/2030 Chemical 2025/12/04 New application|CEP granted|04/12/2025
2775 Nebivolol hydrochloride ALKEM LABORATORIES LIMITED Mumbai IN 100005554;100010367 CEP 2024-481 - Rev 00 2025/12/04 Valid 04/12/2030 Chemical 2025/12/04 New application|CEP granted|04/12/2025
3052 Lercanidipine hydrochloride, Amorphous MAITHRI DRUGS PRIVATE LIMITED Bonthapally Village IN 100020971;100029680 CEP 2024-409 - Rev 00 2025/12/04 Valid 04/12/2030 Chemical 2025/12/04 New application|CEP granted|04/12/2025
2741 Sulfadimethoxine ANUH PHARMA LTD. Mumbai IN 100021566;100030259 CEP 2024-522 - Rev 00 2025/12/04 Valid 04/12/2030 Chemical 2025/12/04 New application|CEP granted|04/12/2025
1491 Amlodipine besilate, Site-II HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2025-407 - Rev 00 2025/12/04 Valid 04/12/2030 Chemical 2025/12/04 New application|CEP granted|04/12/2025
937 Minoxidil IOL CHEMICALS AND PHARMACEUTICALS LIMITED Ludhiana IN 100017919;100037377 CEP 2024-558 - Rev 00 2025/12/04 Valid 04/12/2030 Chemical 2025/12/04 New application|CEP granted|04/12/2025
2583 Montelukast sodium SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN 100044578;100073706 CEP 2024-125 - Rev 00 2025/12/03 Valid 03/12/2030 Chemical 2025/12/03 New application|CEP granted|03/12/2025
391 Furosemide, Alternative process SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN 100015104;100023787 CEP 2013-273 - Rev 01 2025/12/03 Valid Chemical 2025/12/03 Minor revision|CEP granted|03/12/2025;
Minor revision|Accepted - CEP remains valid|20/09/2022;
Minor revision|Accepted - CEP remains valid|21/03/2022
3095 Dabigatran etexilate mesilate HIKAL LIMITED Bangalore IN 100014769;100023445 CEP 2024-363 - Rev 00 2025/12/03 Valid 03/12/2030 Chemical 2025/12/03 New application|CEP granted|03/12/2025
930 Lysine Hydrochloride EVONIK REXIM S.A.S. Ham FR 100012329;100020964 CEP 2003-057 - Rev 06 2025/12/03 Valid Chemical 2025/12/03 Minor revision|CEP granted|03/12/2025;
Notification|CEP granted|04/04/2022
2617 Aripiprazole OLON S.P.A. Rodano IT 100012085;100019537 CEP 2014-188 - Rev 02 2025/12/03 Valid Chemical 2025/12/03 Administrative procedure|CEP granted|03/12/2025;
Minor revision|CEP granted|07/11/2025;
Renewal|CEP granted|02/06/2021;
Minor revision|Accepted - CEP remains valid|12/10/2020
3087 Ticagrelor Changzhou Pharmaceutical Factory Changzhou CN 100012704;100018611 CEP 2021-333 - Rev 02 2025/12/03 Valid 26/05/2028 Chemical 2025/12/03 Minor revision|CEP granted|03/12/2025;
Minor revision|CEP granted|26/08/2024;
New application|CEP granted|30/05/2023
1732 Norgestimate, Optimized process STERLING S.p.A. Solomeo Di Corciano IT 100024377;100033551 CEP 2021-049 - Rev 03 2025/12/03 Valid 03/01/2027 Chemical 2025/12/03 Minor revision|CEP granted|03/12/2025;
Notification|CEP granted|12/10/2022;
Minor revision|Rejected|03/02/2023;
Minor revision|CEP granted|13/04/2022;
New application|CEP granted|03/01/2022
665 Econazole nitrate, Powder, micronised PMC ISOCHEM Vert Le Petit FR 100011861;100020972 CEP 2019-074 - Rev 02 2025/12/03 Valid Chemical 2025/12/03 Renewal|CEP granted|03/12/2025;
Minor revision|CEP granted|08/04/2025
1655 Mitomycin CONCORD BIOTECH LIMITED Ahmedabad IN 100005519;100000897 CEP 2019-308 - Rev 01 2025/12/02 Valid Chemical 2025/12/02 Renewal|CEP granted|02/12/2025
2330 Leflunomide MAPRIMED S.A. Buenos Aires AR 100012039;100018552 CEP 2018-252 - Rev 03 2025/12/02 Valid Chemical 2025/12/02 Renewal|CEP granted|02/12/2025;
Minor revision|CEP granted|03/06/2025;
Notification|Accepted - CEP remains valid|04/12/2023;
Minor revision|CEP granted|27/10/2022;
Minor revision|Rejected|24/05/2022
2119 Venlafaxine hydrochloride, Standard and milled, form II MOEHS IBERICA S.L. Rubi ES 100029092;100068825 CEP 2006-182 - Rev 05 2025/12/02 Valid Chemical 2025/12/02 Minor revision|CEP granted|02/12/2025;
Notification|Accepted - CEP remains valid|21/02/2023;
Minor revision|Accepted - CEP remains valid|28/07/2022;
Minor revision|Accepted - CEP remains valid|28/03/2022;
Minor revision|Accepted - CEP remains valid|24/01/2022;
Minor revision|Accepted - CEP remains valid|19/03/2021
748 Vinblastine Sulfate, Process 2 MINAKEM HIGH POTENT Mont-Saint-Guibert BE 100011725;100022401 CEP 2020-065 - Rev 02 2025/12/02 Valid Chemical 2025/12/02 Renewal|CEP granted|02/12/2025;
Notification|Accepted - CEP remains valid|02/04/2024;
Minor revision|CEP granted|17/07/2023;
New application|CEP granted|09/09/2020
1449 Mometasone furoate, Micronised STERLING S.p.A. Solomeo Di Corciano IT 100024377;100033551 CEP 2025-335 - Rev 01 2025/12/02 Valid 17/11/2030 Chemical 2025/12/02 Minor revision|CEP granted|02/12/2025;
New application|CEP granted|17/11/2025

数据库说明:

当前数据更新日期:2026年02月10日。
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