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
2631 Rosuvastatin calcium, R1-Process CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. Delft NL 100002351;100005259 CEP 2025-219 - Rev 00 2025/07/30 Valid 30/07/2030 Chemical 2025/07/30 New application|CEP granted|30/07/2025
2270 Sildenafil citrate SMILAX LABORATORIES LIMITED Hyderabad IN 100011578;100021649 CEP 2024-155 - Rev 00 2025/07/30 Valid 30/07/2030 Chemical 2025/07/30 New application|CEP granted|30/07/2025
1280 Zolpidem tartrate LAKE CHEMICALS PRIVATE LIMITED Bengaluru IN 100012055;100053935 CEP 2018-022 - Rev 02 2025/07/29 Valid Chemical 2025/07/29 Minor revision|CEP granted|29/07/2025;
Renewal|CEP granted|03/07/2024;
Monograph revision|Accepted - CEP remains valid|02/10/2020
2021 Terazosin hydrochloride dihydrate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2007-207 - Rev 06 2025/07/29 Valid Chemical 2025/07/29 Notification|CEP granted|29/07/2025;
Minor revision|Accepted - CEP remains valid|01/09/2023;
Monograph revision|CEP granted|19/04/2022;
Notification|Accepted - CEP remains valid|17/09/2020
755 Carbidopa, Micronised FERMION OY Espoo FI 100011508;100020280 CEP 2025-265 - Rev 00 2025/07/29 Valid 29/07/2030 Chemical 2025/07/29 New application|CEP granted|29/07/2025
2196 Bicalutamide, Crystalline form-I, micronised and non-micronised MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN 100011732;100023530 CEP 2012-283 - Rev 02 2025/07/29 Valid Chemical 2025/07/29 Minor revision|CEP granted|29/07/2025;
Notification|CEP granted|10/08/2023
1058 Vancomycin hydrochloride, Precipitated fine powder LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN 100020920;100029633 CEP 2020-119 - Rev 04 2025/07/29 Valid Chemical 2025/07/29 Renewal|CEP granted|29/07/2025;
Monograph revision|CEP granted|29/10/2024;
Notification|Accepted - CEP remains valid|10/06/2024;
Administrative procedure|CEP granted|11/04/2023;
Minor revision|CEP granted|31/03/2023;
Minor revision|Rejected|11/01/2023;
Notification|Accepted - CEP remains valid|27/05/2021;
New application|CEP granted|04/08/2020
2131 Tamsulosin hydrochloride SWATI SPENTOSE PRIVATE LIMITED Mumbai IN 100021605;100052219 CEP 2022-133 - Rev 02 2025/07/29 Valid 30/11/2028 Chemical 2025/07/29 Minor revision|CEP granted|29/07/2025;
Notification|CEP granted|16/09/2024;
New application|CEP granted|30/11/2023
703 Atenolol KOPRAN RESEARCH LABORATORIES LIMITED Mumbai IN 100033667;100081898 CEP 1998-017 - Rev 08 2025/07/29 Valid Chemical 2025/07/29 Minor revision|CEP granted|29/07/2025;
Minor revision|CEP granted|20/06/2024;
Major revision|CEP granted|12/03/2021
2735 Gadobutrol monohydrate WEINAN MANARECO PHARMACEUTICAL CO., LTD. Weinan CN 100052364;100092209 CEP 2024-388 - Rev 00 2025/07/29 Valid 29/07/2030 Chemical 2025/07/29 New application|CEP granted|29/07/2025
2932 Rivaroxaban, Micronised, non-micronised SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN 100023303;100032437 CEP 2020-327 - Rev 02 2025/07/29 Valid 25/07/2027 Chemical 2025/07/29 Minor revision|CEP granted|29/07/2025;
Minor revision|CEP granted|11/01/2024;
Minor revision|Accepted - CEP remains valid|07/08/2023;
New application|CEP granted|25/07/2022
2132 Torasemide, Form-I HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2019-255 - Rev 02 2025/07/29 Valid 26/08/2027 Chemical 2025/07/29 Minor revision|CEP granted|29/07/2025;
Minor revision|CEP granted|08/02/2023
574 Cholecalciferol concentrate (powder form), 100 000 IU/g, with all-rac-α-tocopherol and sodium ascorbate FERMENTA BIOTECH LIMITED Thane (W) IN 100018502;100042408 CEP 2024-588 - Rev 00 2025/07/29 Valid 29/07/2030 Chemical and TSE 2025/07/29 New application|CEP granted|29/07/2025
2288 Citalopram hydrobromide APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2009-043 - Rev 03 2025/07/29 Valid Chemical 2025/07/29 Minor revision|CEP granted|29/07/2025;
Notification|CEP granted|03/01/2024;
Minor revision|Accepted - CEP remains valid|07/03/2022
234 Norethisterone, Micronised VALDEPHARM Val de Reuil FR 100011898;100018788 CEP 2011-094 - Rev 04 2025/07/29 Valid Chemical 2025/07/29 Notification|CEP granted|29/07/2025;
Notification|CEP granted|05/09/2022;
Minor revision|CEP granted|04/03/2022;
Minor revision|CEP granted|21/04/2021
2814 Thiocolchicoside hydrate SARV BIO LABS PRIVATE LIMITED Sirmaur IN 100039294;100061855 CEP 2023-024 - Rev 00 2025/07/29 Valid 29/07/2030 Chemical 2025/07/29 New application|CEP granted|29/07/2025
1794 Paclitaxel, Produced by fermentation - Site Agno PHYTON BIOTECH LLC Delta CA 100014889;100038370 CEP 2024-022 - Rev 01 2025/07/29 Valid 16/07/2029 Chemical 2025/07/29 Minor revision|CEP granted|29/07/2025;
New application|CEP granted|16/07/2024
1445 Magnesium aspartate dihydrate DR. PAUL LOHMANN GMBH & CO. KGAA Emmerthal DE 100022728;100031429 CEP 2013-042 - Rev 01 2025/07/29 Valid Chemical 2025/07/29 Minor revision|CEP granted|29/07/2025
1614 Estradiol valerate, Non-micronised and micronised ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD. Taizhou CN 100022759;100031459 CEP 2023-362 - Rev 00 2025/07/29 Valid 29/07/2030 Chemical 2025/07/29 New application|CEP granted|29/07/2025
2931 Sorafenib tosilate, Form-III HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2021-324 - Rev 02 2025/07/29 Valid 15/09/2027 Chemical 2025/07/29 Monograph revision|CEP granted|29/07/2025;
Minor revision|CEP granted|25/11/2024;
New application|CEP granted|15/09/2022

数据库说明:

当前数据更新日期:2025年12月22日。
©2006-2025 DrugFuture->Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM