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
2896 Thiocolchicoside crystallised from ethanol INDIA GLYCOLS LIMITED Dehradun IN 100038944;100061244 CEP 2020-066 - Rev 02 2026/01/21 Valid 06/04/2027 Chemical 2026/01/21 Minor revision|CEP granted|21/01/2026;
Major revision|CEP granted|05/01/2024;
New application|CEP granted|06/04/2022
1444 Macrogols, Type 3350 and 4000 SASOL GERMANY GMBH Marl DE 100043602;100072176 CEP 2009-392 - Rev 02 2026/01/21 Valid Chemical 2026/01/21 Notification|CEP granted|21/01/2026;
Major revision|CEP granted|06/07/2022
2234 Meropenem trihydrate, Synthetic origin, Sterile, Process II SHENZHEN HAIBIN PHARMACEUTICAL CO., LTD. Shenzhen City CN 100021561;100030252 CEP 2024-097 - Rev 02 2026/01/21 Valid 11/06/2030 Chemical 2026/01/21 Minor revision|CEP granted|21/01/2026;
Administrative procedure|CEP granted|19/08/2025;
New application|CEP granted|11/06/2025
2409 Diacerein RAKSHIT PHARMACEUTICALS LIMITED Anakapalli District IN 100039283;100061839 CEP 2024-436 - Rev 00 2026/01/21 Valid 21/01/2031 Chemical 2026/01/21 New application|CEP granted|21/01/2026
2019 Perindopril tert-butylamine, Crystalline form-α MSN PHARMACHEM PRIVATE LIMITED Sangareddy IN 100014794;100023345 CEP 2025-249 - Rev 00 2026/01/21 Valid 21/01/2031 Chemical 2026/01/21 New application|CEP granted|21/01/2026
45 Methyldopa, Site Yongtai Chiral, Process A ZHEJIANG YONGTAI CHIRAL MEDICINE TECHNOLOGY CO. LTD. Taizhou CN 100041319;100068021 CEP 2025-526 - Rev 00 2026/01/21 Valid 21/01/2031 Chemical 2026/01/21 New application|CEP granted|21/01/2026
2637 Pemetrexed disodium heptahydrate JIANGSU HANSOH PHARMACEUTICAL GROUP CO., LTD. Lianyungang City CN 100034195;100092374 CEP 2022-265 - Rev 01 2026/01/21 Valid 19/06/2028 Chemical 2026/01/21 Minor revision|CEP granted|21/01/2026;
Minor revision|Accepted - CEP remains valid|02/10/2024;
New application|CEP granted|19/06/2023
1575 Tiapride hydrochloride ICROM S.R.L. Concorezzo IT 100022464;100031145 CEP 2023-003 - Rev 01 2026/01/20 Valid 19/01/2029 Chemical 2026/01/20 Minor revision|CEP granted|20/01/2026;
New application|CEP granted|19/01/2024
2896 Thiocolchicoside crystallised from ethanol QUAD LIFESCIENCES PRIVATE LIMITED S.A.S Nagar IN 100050170;100087590 CEP 2023-103 - Rev 00 2026/01/20 Valid 20/01/2031 Chemical 2026/01/20 New application|CEP granted|20/01/2026
2617 Aripiprazole ALKEM LABORATORIES LIMITED Mumbai IN 100005554;100010367 CEP 2024-180 - Rev 00 2026/01/20 Valid 20/01/2031 Chemical 2026/01/20 New application|CEP granted|20/01/2026
198 Oxytetracycline hydrochloride HEBEI SHENGXUE DACHENG PHARMACEUTICAL CO. LTD. Shijiazhuang CN 100016575;100025368 CEP 2021-099 - Rev 02 2026/01/20 Valid 16/06/2027 Chemical 2026/01/20 Minor revision|CEP granted|20/01/2026;
Monograph revision|Accepted - CEP remains valid|23/12/2024;
Minor revision|Accepted - CEP remains valid|07/09/2023;
Administrative procedure|CEP granted|28/06/2022;
New application|CEP granted|20/06/2022
68 Atropine sulfate RESONANCE LABORATORIES PRIVATE LIMITED Bengaluru IN 100024014;100033182 CEP 2023-234 - Rev 00 2026/01/19 Valid 19/01/2031 Chemical 2026/01/19 New application|CEP granted|19/01/2026
2445 Adapalene AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN 100045727;100075371 CEP 2022-158 - Rev 01 2026/01/19 Valid 19/06/2029 Chemical 2026/01/19 Minor revision|CEP granted|19/01/2026;
New application|CEP granted|19/06/2024
1210 Fentanyl VERANOVA, L.P. West Deptford US 100012273;100018937 CEP 2000-141 - Rev 04 2026/01/19 Valid Chemical 2026/01/19 Minor revision|CEP granted|19/01/2026
110 Zinc chloride Merck KGaA Darmstadt DE 100000742;100006955 CEP 2014-168 - Rev 03 2026/01/19 Valid Chemical 2026/01/19 Minor revision|CEP granted|19/01/2026;
Major revision|CEP granted|03/10/2022;
Minor revision|CEP granted|29/11/2021;
Renewal|CEP granted|27/10/2020
698 Warfarin sodium IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2009-041 - Rev 03 2026/01/19 Valid Chemical 2026/01/19 Minor revision|CEP granted|19/01/2026;
Notification|Accepted - CEP remains valid|23/06/2023;
Minor revision|Accepted - CEP remains valid|09/04/2020
2762 Capecitabine HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2014-355 - Rev 05 2026/01/19 Valid Chemical 2026/01/19 Minor revision|CEP granted|19/01/2026;
Minor revision|CEP granted|20/05/2025;
Minor revision|CEP granted|22/01/2025;
Notification|Accepted - CEP remains valid|05/09/2023;
Major revision|CEP granted|16/06/2023;
Major revision|CEP granted|18/10/2022;
Renewal|CEP granted|24/09/2021;
Notification|CEP granted|24/07/2020
. Bovine Calf Serum MEDIATECH INC. Manassas US 100051460;100090205 CEP 2018-305 - Rev 02 2026/01/19 Valid TSE 2026/01/19 Major revision|CEP granted|19/01/2026;
Renewal|CEP granted|03/07/2024
2020 Rilmenidine dihydrogen phosphate ZENTIVA K.S. Prague CZ 100004108;100097772 CEP 2023-124 - Rev 01 2026/01/19 Valid 18/12/2029 Chemical 2026/01/19 Notification|CEP granted|19/01/2026;
New application|CEP granted|19/12/2024
2131 Tamsulosin hydrochloride, Ankleshwar site ZENTIVA K.S. Prague CZ 100004108;100097772 CEP 2023-469 - Rev 01 2026/01/19 Valid 25/04/2029 Chemical 2026/01/19 Notification|CEP granted|19/01/2026;
New application|CEP granted|25/04/2024

数据库说明:

当前数据更新日期:2026年02月10日。
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