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
2600 Olmesartan medoxomil CHROMO LABORATORIES INDIA PRIVATE LIMITED Pashamylaram IN 100038839;100060978 CEP 2018-083 - Rev 04 2025/04/25 Valid Chemical 2025/04/25 Renewal|CEP granted|25/04/2025;
Minor revision|CEP granted|03/08/2023;
Notification|Accepted - CEP remains valid|06/01/2023;
Minor revision|Accepted - CEP remains valid|21/12/2022;
Minor revision|CEP granted|06/09/2022;
Monograph revision|CEP granted|06/05/2022
2017 Oxaliplatin, Process HER-2 HERAEUS PRECIOUS METALS GMBH & CO. KG Hanau DE 100012310;100021629 CEP 2006-137 - Rev 06 2025/04/25 Valid Chemical 2025/04/25 Notification|CEP granted|25/04/2025;
Notification|CEP granted|02/10/2023;
Notification|CEP granted|18/07/2022;
Notification|CEP granted|24/03/2021
1614 Estradiol valerate ASPEN OSS B.V. Oss NL 100011619;100050602 CEP 2009-171 - Rev 02 2025/04/25 Valid Chemical 2025/04/25 Notification|CEP granted|25/04/2025
. Foetal Bovine Serum GLOBAL LIFE SCIENCES SOLUTIONS NEW ZEALAND Tauranga NZ 100052523;100092494 CEP 2000-211 - Rev 05 2025/04/25 Valid TSE 2025/04/25 Notification|CEP granted|25/04/2025;
Notification|CEP granted|25/02/2022;
Notification|CEP granted|05/06/2020
1517 Flumequine IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2001-318 - Rev 05 2025/04/25 Valid Chemical 2025/04/25 Minor revision|CEP granted|25/04/2025;
Notification|Rejected|08/04/2025;
Minor revision|CEP granted|16/07/2020
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
883 Calcitriol TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 1998-055 - Rev 08 2025/04/25 Valid Chemical 2025/04/25 Minor revision|CEP granted|25/04/2025;
Monograph revision|Accepted - CEP remains valid|26/11/2024;
Minor revision|CEP granted|16/08/2024;
Notification|Rejected|06/06/2024;
Notification|Accepted - CEP remains valid|06/06/2023;
Minor revision|Accepted - CEP remains valid|21/04/2022;
Notification|CEP granted|20/12/2021;
Minor revision|CEP granted|09/06/2021
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
1444 Macrogols, Types 3350 and 4000 THE DOW CHEMICAL COMPANY Midland US 100011909;100090025 CEP 2006-085 - Rev 05 2025/04/25 Valid Chemical 2025/04/25 Notification|CEP granted|25/04/2025;
Administrative procedure|CEP granted|18/09/2024;
Minor revision|Accepted - CEP remains valid|06/06/2024;
Administrative procedure|CEP granted|29/03/2021;
Minor revision|CEP granted|03/02/2021
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
2751 Valaciclovir hydrochloride hydrate HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2018-102 - Rev 03 2025/04/25 Valid Chemical 2025/04/25 Renewal|CEP granted|25/04/2025;
Minor revision|Accepted - CEP remains valid|20/08/2024;
Minor revision|CEP granted|20/02/2024;
Minor revision|Accepted - CEP remains valid|27/01/2021;
Minor revision|CEP granted|07/08/2020
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
2445 Adapalene, Micronised and non-micronised OLON S.P.A. Rodano IT 100012085;100019537 CEP 2022-259 - Rev 01 2025/04/25 Valid 28/07/2028 Chemical 2025/04/25 Minor revision|CEP granted|25/04/2025;
New application|CEP granted|28/07/2023

数据库说明:

当前数据更新日期:2025年04月28日。
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