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
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
2244 Tacrolimus monohydrate, Process II CONCORD BIOTECH LIMITED Ahmedabad IN 100005519;100000897 CEP 2020-227 - Rev 02 2025/07/29 Valid Chemical 2025/07/29 Renewal|CEP granted|29/07/2025;
Major revision|CEP granted|19/12/2022;
New application|CEP granted|26/11/2020
3139 Brivaracetam, Micronised and Non-micronised MAITHRI LABORATORIES PRIVATE LIMITED Gaddapotharam Village IN 100013041;100021615 CEP 2024-061 - Rev 01 2025/07/29 Valid 12/08/2029 Chemical 2026/02/10 Minor revision|Accepted - CEP remains valid|10/02/2026;
Minor revision|CEP granted|29/07/2025;
New application|CEP granted|12/08/2024
1058 Vancomycin hydrochloride, Lyophilized LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN 100020920;100029633 CEP 2020-058 - Rev 04 2025/07/28 Valid Chemical 2025/07/28 Renewal|CEP granted|28/07/2025;
Monograph revision|CEP granted|28/10/2024;
Minor revision|CEP granted|25/05/2023;
Minor revision|CEP granted|21/01/2022;
New application|CEP granted|22/07/2020
2751 Valaciclovir hydrochloride hydrate FLAMMA S.P.A. Chignolo d'Isola IT 100012051;100020885 CEP 2018-073 - Rev 04 2025/07/28 Valid Chemical 2025/07/28 Transfer of holdership|CEP granted|28/07/2025;
Renewal|CEP granted|21/01/2025;
Minor revision|Accepted - CEP remains valid|24/04/2023;
Minor revision|CEP granted|30/05/2022;
Notification|CEP granted|22/11/2021;
Minor revision|Accepted - CEP remains valid|04/05/2021

数据库说明:

当前数据更新日期:2026年04月07日。
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