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
944 Piroxicam PFIZER INC. New York US 100004191;100077681 CEP 2001-427 - Rev 02 2025/04/25 Valid Chemical 2025/04/25 Minor revision|CEP granted|25/04/2025
3059 Melatonin SWATI SPENTOSE PRIVATE LIMITED Mumbai IN 100021605;100052219 CEP 2023-075 - Rev 03 2025/04/25 Valid 22/05/2029 Chemical 2025/04/25 Minor revision|CEP granted|25/04/2025;
Minor revision|CEP granted|17/02/2025;
Notification|CEP granted|16/09/2024;
New application|CEP granted|22/05/2024
2781 Tolterodine tartrate HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2020-032 - Rev 01 2025/04/25 Valid 17/03/2026 Chemical 2025/04/25 Minor revision|CEP granted|25/04/2025;
Minor revision|Accepted - CEP remains valid|24/08/2023;
New application|CEP granted|17/03/2021
2254 Moxifloxacin hydrochloride ENALTEC LABS PRIVATE LIMITED Navi Mumbai IN 100015510;100024234 CEP 2022-487 - Rev 00 2025/04/25 Valid 25/04/2030 Chemical 2025/04/25 New application|CEP granted|25/04/2025
2296 Pantoprazole sodium sesquihydrate SHOUGUANG FUKANG PHARMACEUTICAL CO., LTD. Shouguang City CN 100017920;100052986 CEP 2013-350 - Rev 01 2025/04/25 Valid Chemical 2025/04/25 Major revision|CEP granted|25/04/2025;
Renewal|CEP granted|15/09/2020
2173 Gabapentin ZHEJIANG BAMBOO PHARMACEUTICALS CO.,LTD. Shaoxing CN 100047946;100079294 CEP 2023-027 - Rev 02 2025/04/25 Valid 04/01/2029 Chemical 2025/04/25 Minor revision|CEP granted|25/04/2025;
Minor revision|CEP granted|11/03/2024;
New application|CEP granted|04/01/2024
1513 Etofenamate DUKE CHEM, S.A.U. Olérdola ES 100022432;100031112 CEP 2014-154 - Rev 02 2025/04/25 Valid Chemical 2025/04/25 Minor revision|CEP granted|25/04/2025;
Minor revision|CEP granted|27/02/2024;
Renewal|CEP granted|02/10/2020
916 Hydroxyzine hydrochloride IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2010-076 - Rev 04 2025/04/25 Valid Chemical 2025/04/25 Minor revision|CEP granted|25/04/2025;
Minor revision|CEP granted|11/09/2024;
Notification|Accepted - CEP remains valid|23/06/2023;
Minor revision|CEP granted|03/08/2021
2888 Rupatadine fumarate, Micronised and Non-micronised CADILA PHARMACEUTICALS LIMITED Ankleshwar IN 100003616;100000498 CEP 2018-161 - Rev 03 2025/04/25 Valid Chemical 2025/04/25 Renewal|CEP granted|25/04/2025;
Minor revision|CEP granted|25/01/2024;
Minor revision|Accepted - CEP remains valid|01/08/2022;
Minor revision|CEP granted|18/12/2020
2333 Fluvastatin sodium, Amorphous BIOCON LIMITED Bengaluru IN 100011487;100018595 CEP 2016-075 - Rev 01 2025/04/25 Valid Chemical 2025/04/25 Minor revision|CEP granted|25/04/2025;
Renewal|CEP granted|14/10/2022;
Minor revision|Rejected|25/01/2022;
Major revision|Rejected|14/09/2021
1750 Fluticasone propionate, Micronised GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED London GB 100005535;100093170 CEP 2018-229 - Rev 03 2025/04/25 Valid Chemical 2025/04/25 Notification|CEP granted|25/04/2025;
Renewal|CEP granted|16/12/2024;
Monograph revision|Accepted - CEP remains valid|12/07/2021;
Notification|CEP granted|07/12/2020
855 Praziquantel SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN 100032307;100053537 CEP 2021-162 - Rev 00 2025/04/25 Valid 25/04/2030 Chemical 2025/04/25 New application|CEP granted|25/04/2025
823 Etoposide MAC CHEM PRODUCTS (INDIA) PRIVATE LIMITED Mumbai IN 100023737;100061579 CEP 2020-074 - Rev 02 2025/04/25 Valid 25/07/2027 Chemical 2025/04/25 Minor revision|CEP granted|25/04/2025;
Administrative procedure|CEP granted|30/04/2024;
New application|CEP granted|25/07/2022
391 Furosemide MANGALAM DRUGS & ORGANICS LTD. Mumbai IN 100012477;100021137 CEP 2019-063 - Rev 02 2025/04/25 Valid 07/09/2026 Chemical 2025/04/25 Notification|CEP granted|25/04/2025;
Major revision|CEP granted|02/03/2023
2541 Quetiapine Fumarate ZHEJIANG SYNCOZYMES BIO-PHARMACEUTICAL CO. LTD. Shaoxing CN 100049378;100084024 CEP 2024-190 - Rev 01 2025/04/25 Valid 08/04/2030 Chemical 2025/04/25 Administrative procedure|CEP granted|25/04/2025;
New application|CEP granted|08/04/2025
2358 Teicoplanin, Changhai site ZHEJIANG MEDICINE CO., LTD. Shaoxing CN 100022357;100084942 CEP 2022-436 - Rev 01 2025/04/25 Valid 10/02/2028 Chemical 2025/04/25 Minor revision|CEP granted|25/04/2025;
New application|CEP granted|10/02/2023
2932 Rivaroxaban HIKAL LIMITED Bangalore IN 100014769;100023445 CEP 2023-351 - Rev 00 2025/04/25 Valid 25/04/2030 Chemical 2025/04/25 New application|CEP granted|25/04/2025
141 Ethionamide APICHEM LABORATORIES PRIVATE LIMITED Yadadri Bhuvanagiri District IN 100049373;100087707 CEP 2024-502 - Rev 00 2025/04/25 Valid 25/04/2030 Chemical 2025/04/25 New application|CEP granted|25/04/2025
2577 Oxcarbazepine ARENE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100033956;100079880 CEP 2024-343 - Rev 00 2025/04/25 Valid 25/04/2030 Chemical 2025/04/25 New application|CEP granted|25/04/2025
2288 Citalopram hydrobromide, Sulfuric Acid Process, Micronised and non-micronised ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN 100011833;100018698 CEP 2025-004 - Rev 00 2025/04/25 Valid 25/04/2030 Chemical 2025/04/25 New application|CEP granted|25/04/2025

数据库说明:

当前数据更新日期:2026年02月03日。
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