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
1491 Amlodipine besilate DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2003-007 - Rev 07 2025/06/06 Valid Chemical 2025/06/06 Minor revision|CEP granted|06/06/2025
616 Haloperidol MANKIND PHARMA LIMITED New Delhi IN 100045169;100074533 CEP 2020-026 - Rev 02 2025/06/06 Valid 05/01/2027 Chemical 2025/06/06 Notification|CEP granted|06/06/2025;
Major revision|CEP granted|22/02/2024;
New application|CEP granted|05/01/2022
2787 Esomeprazole magnesium dihydrate HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2014-333 - Rev 03 2025/06/06 Valid Chemical 2025/06/06 Notification|CEP granted|06/06/2025;
Minor revision|CEP granted|08/01/2025;
Notification|CEP granted|07/03/2023;
Renewal|CEP granted|26/04/2022;
Minor revision|CEP granted|11/03/2020
1431 Haloperidol decanoate MANKIND PHARMA LIMITED New Delhi IN 100045169;100074533 CEP 2020-080 - Rev 02 2025/06/06 Valid 20/05/2027 Chemical 2025/06/06 Notification|CEP granted|06/06/2025;
Minor revision|Accepted - CEP remains valid|08/11/2024;
Major revision|CEP granted|30/08/2024;
New application|CEP granted|20/05/2022
533 Triamcinolone acetonide SWATI SPENTOSE PRIVATE LIMITED Mumbai IN 100021605;100052219 CEP 2022-255 - Rev 00 2025/06/06 Valid 06/06/2030 Chemical 2025/06/06 New application|CEP granted|06/06/2025
1519 Flurbiprofen Wisdom Pharmaceutical Co., Ltd. Haimen CN 100014837;100023467 CEP 2024-024 - Rev 00 2025/06/06 Valid 06/06/2030 Chemical 2025/06/06 New application|CEP granted|06/06/2025
2191 Atorvastatin calcium, Trihydrate MANKIND PHARMA LIMITED New Delhi IN 100045169;100074533 CEP 2022-262 - Rev 01 2025/06/06 Valid 16/02/2029 Chemical 2025/06/06 Notification|CEP granted|06/06/2025;
New application|CEP granted|16/02/2024
2866 Gefitinib ZHEJIANG JIUZHOU PHARMACEUTICAL CO. LTD. Taizhou CN 100011841;100018560 CEP 2018-236 - Rev 02 2025/06/05 Valid Chemical 2025/06/05 Renewal|CEP granted|05/06/2025;
Minor revision|CEP granted|02/02/2022;
Minor revision|Accepted - CEP remains valid|19/08/2021
333 Heparin sodium, For parenteral preparations YANTAI DONGCHENG BIOCHEMICALS CO. LTD. Yantai CN 100022810;100052422 CEP 2003-197 - Rev 11 2025/06/05 Valid Chemical 2025/06/05 Major revision|CEP granted|05/06/2025;
Monograph revision|Accepted - CEP remains valid|13/06/2024;
Major revision|CEP granted|28/09/2022;
Major revision|CEP granted|21/01/2022
1699 Mesalazine BEC CHEMICALS PRIVATE LIMITED Mumbai IN 100016436;100025221 CEP 2011-100 - Rev 01 2025/06/05 Valid Chemical 2025/06/05 Minor revision|CEP granted|05/06/2025;
Minor revision|Accepted - CEP remains valid|31/07/2024;
Minor revision|Accepted - CEP remains valid|18/04/2023;
Minor revision|Accepted - CEP remains valid|09/10/2020
946 Ranitidine hydrochloride, Crystalline powder grade and D.C. grade ORCHEV PHARMA PRIVATE LIMITED Rajkot IN 100020650;100029403 CEP 2007-320 - Rev 03 2025/06/05 Valid Chemical 2025/06/05
925 Levomepromazine maleate COHANCE LIFESCIENCES LIMITED Mumbai IN 100011755;100090273 CEP 2018-144 - Rev 05 2025/06/05 Valid Chemical 2025/06/05 Minor revision|CEP granted|05/06/2025;
Renewal|Accepted - CEP remains valid|24/03/2025;
Notification|CEP granted|10/07/2024;
Minor revision|Accepted - CEP remains valid|09/04/2024;
Monograph revision|CEP granted|09/08/2023;
Notification|CEP granted|12/02/2021;
Minor revision|CEP granted|07/08/2020
1651 Clarithromycin, Form-II (Process-II) SYNTHIMED LABS PRIVATE LIMITED Derabassi IN 100052287;100092080 CEP 2024-435 - Rev 01 2025/06/05 Valid 11/03/2030 Chemical 2025/06/05 Minor revision|CEP granted|05/06/2025;
New application|CEP granted|11/03/2025
396 Hydrogen peroxide solution (30 per cent) ARKEMA FRANCE Puteaux FR 100049819;100096345 CEP 2024-402 - Rev 00 2025/06/05 Valid 05/06/2030 Chemical 2025/06/05 New application|CEP granted|05/06/2025
1470 Simeticone, SILFAR S 188 WACKER CHEMIE AG Munich DE 100020886;100093340 CEP 2020-264 - Rev 01 2025/06/05 Valid Chemical 2025/06/06 Renewal|CEP granted|06/06/2025;
Notification|Accepted - CEP remains valid|02/09/2021;
New application|CEP granted|23/10/2020
2372 Esomeprazole magnesium trihydrate NIFTY LABS PRIVATE LIMITED Hyderabad IN 100014767;100042749 CEP 2018-245 - Rev 04 2025/06/05 Valid Chemical 2025/06/05 Administrative procedure|CEP granted|05/06/2025;
Renewal|CEP granted|23/05/2025;
Minor revision|CEP granted|12/12/2023;
Notification|CEP granted|16/08/2022
2630 Rivastigmine hydrogen tartrate SHODHANA LABORATORIES PRIVATE LIMITED Hyderabad IN 100021550;100030244 CEP 2019-066 - Rev 02 2025/06/05 Valid Chemical 2025/06/05 Renewal|CEP granted|05/06/2025;
Minor revision|CEP granted|31/03/2021
2617 Aripiprazole, Form II TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2018-267 - Rev 03 2025/06/05 Valid Chemical 2025/06/05 Renewal|CEP granted|05/06/2025;
Major revision|CEP granted|17/02/2023;
Notification|CEP granted|23/09/2021;
Monograph revision|Accepted - CEP remains valid|13/04/2021
454 Acetazolamide, Process B NAKODA CHEMICALS LIMITED Hyderabad IN 100018043;100026836 CEP 2010-352 - Rev 02 2025/06/04 Valid Chemical 2025/06/04 Minor revision|CEP granted|04/06/2025;
Minor revision|Accepted - CEP remains valid|16/06/2023;
Notification|CEP granted|13/05/2022
2776 Nicardipine hydrochloride MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN 100011732;100018657 CEP 2024-005 - Rev 00 2025/06/04 Valid 04/06/2030 Chemical 2025/06/04 New application|CEP granted|04/06/2025

数据库说明:

当前数据更新日期:2025年06月09日。
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