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
2757 Aprepitant VIWIT PHARMACEUTICAL CO. LTD Tengzhou CN 100049012;100082223 CEP 2019-025 - Rev 02 2025/02/10 Valid Chemical 2025/02/10 Renewal|CEP granted|10/02/2025;
Administrative procedure|CEP granted|07/04/2020
1121 Lorazepam, Micronised LAKE CHEMICALS PRIVATE LIMITED Bengaluru IN 100012055;100053935 CEP 2012-113 - Rev 01 2025/02/10 Valid Chemical 2025/10/24 Minor revision|Accepted - CEP remains valid|24/10/2025;
Minor revision|CEP granted|10/02/2025
542 Busulfan FARMABIOS S.p.A Gropello Cairoli IT 100011643;100021232 CEP 2018-265 - Rev 01 2025/02/10 Valid Chemical 2025/02/10 Renewal|CEP granted|10/02/2025
2762 Capecitabine VANNSH LIFE SCIENCES PRIVATE LIMITED Visakhapatnam IN 100048559;100080481 CEP 2021-505 - Rev 00 2025/02/10 Valid 10/02/2030 Chemical 2025/02/10 New application|CEP granted|10/02/2025
2578 Tizanidine hydrochloride DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2020-281 - Rev 01 2025/02/10 Valid 05/07/2028 Chemical 2025/02/10 Minor revision|CEP granted|10/02/2025;
New application|CEP granted|05/07/2023
3046 Pemetrexed disodium 2.5-hydrate HUZHOU ZHANWANG PHARMACEUTICAL CO., LTD. Linghu Town CN 100014876;100032460 CEP 2024-013 - Rev 00 2025/02/10 Valid 10/02/2030 Chemical 2025/02/10 New application|CEP granted|10/02/2025
1173 Benserazide hydrochloride CHEMI S.P.A. Cinisello Balsamo IT 100000347;100004429 CEP 2021-226 - Rev 02 2025/02/10 Valid 30/05/2028 Chemical 2025/02/10 Minor revision|CEP granted|10/02/2025;
Minor revision|CEP granted|13/03/2024;
New application|CEP granted|30/05/2023
1442 Leuprorelin HYBIO PHARMACEUTICAL CO., LTD. Shenzhen CN 100014918;100023583 CEP 2019-016 - Rev 01 2025/02/07 Valid Chemical 2025/02/07 Renewal|CEP granted|07/02/2025
3012 Regorafenib monohydrate, Crystalline form MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN 100011732;100023530 CEP 2022-456 - Rev 00 2025/02/07 Valid 07/02/2030 Chemical 2025/02/07 New application|CEP granted|07/02/2025
2535 Levetiracetam SRINI PHARMACEUTICALS PRIVATE LIMITED Choutuppal IN 100018880;100027661 CEP 2018-176 - Rev 01 2025/02/07 Valid Chemical 2025/02/07 Renewal|CEP granted|07/02/2025
2923 Esomeprazole sodium METROCHEM API PRIVATE LIMITED Hyderabad IN 100045158;100074519 CEP 2020-214 - Rev 02 2025/02/07 Valid 30/05/2027 Chemical 2025/02/07 Minor revision|CEP granted|07/02/2025;
Notification|CEP granted|21/06/2024;
New application|CEP granted|30/05/2022
2232 Losartan potassium ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2009-102 - Rev 06 2025/02/07 Valid Chemical 2025/02/07 Minor revision|CEP granted|07/02/2025;
Minor revision|CEP granted|17/11/2023;
Major revision|CEP granted|14/01/2022;
Minor revision|CEP granted|10/03/2020
74 Codeine phosphate hemihydrate, Process 2 ALKALOIDA CHEMICAL COMPANY ZRT. Tiszavasvari HU 100001084;100002269 CEP 2024-443 - Rev 00 2025/02/07 Valid 07/02/2030 Chemical 2025/02/07 New application|CEP granted|07/02/2025
2268 Selamectin for veterinary use CHONGQING QIANTAI PHARMA CO., LTD. Chongqing CN 100053648;100094867 CEP 2023-007 - Rev 01 2025/02/07 Valid 18/04/2029 Chemical 2025/02/07 Transfer of holdership|CEP granted|07/02/2025;
New application|CEP granted|18/04/2024
1381 Xylitol ROCHEM INTERNATIONAL, INC. Hauppauge US 100025314;100067726 CEP 2024-101 - Rev 00 2025/02/07 Valid 07/02/2030 Chemical 2025/02/07 New application|CEP granted|07/02/2025
1998 Nicergoline, Taixing site CHONGQING QIANTAI PHARMA CO., LTD. Chongqing CN 100053648;100094867 CEP 2023-311 - Rev 01 2025/02/07 Valid 01/02/2029 Chemical 2025/02/07 Transfer of holdership|CEP granted|07/02/2025;
New application|CEP granted|01/02/2024
2362 Rifaximin, Alpha form, sieved OLON S.P.A. Rodano IT 100012085;100019537 CEP 2024-520 - Rev 00 2025/02/06 Valid 06/02/2030 Chemical 2025/02/06 New application|CEP granted|06/02/2025
2465 Irbesartan ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2011-153 - Rev 05 2025/02/05 Valid Chemical 2025/02/05 Minor revision|CEP granted|05/02/2025;
Major revision|CEP granted|16/03/2023;
Minor revision|CEP granted|30/08/2021
2011 Calcipotriol CERBIOS-PHARMA SA Barbengo CH 100015546;100024284 CEP 2009-188 - Rev 06 2025/02/05 Valid Chemical 2025/02/05 Minor revision|CEP granted|05/02/2025;
Minor revision|CEP granted|02/11/2023;
Minor revision|Accepted - CEP remains valid|25/05/2022;
Minor revision|Accepted - CEP remains valid|26/11/2021;
Notification|Rejected|05/10/2021;
Minor revision|CEP granted|11/09/2020
1633 Azelastine hydrochloride MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN 100011732;100018657 CEP 2011-363 - Rev 02 2025/02/05 Valid Chemical 2025/02/05 Minor revision|CEP granted|05/02/2025;
Minor revision|CEP granted|01/06/2022

数据库说明:

当前数据更新日期:2025年12月08日。
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