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
2019 Perindopril tert-butylamine, PER55LP APOTEX PHARMACHEM INDIA PVT. LTD Bangalore IN R0-CEP 2019-196 - Rev 01 2023/08/21 Valid 31/01/2025 Chemical 2023/08/21 Minor revision|CEP granted|21/08/2023
2932 Rivaroxaban DONG BANG FUTURE TECH & LIFE CO., LTD. Hwaseong-si KR R0-CEP 2021-211 - Rev 00 2023/08/21 Valid 21/08/2028 Chemical 2023/08/21 New application|CEP granted|21/08/2023
2624 Meldonium dihydrate SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO., LTD. Dezhou City CN R0-CEP 2022-113 - Rev 00 2023/08/21 Valid 21/08/2028 Chemical 2023/08/21 New application|CEP granted|21/08/2023
582 Clindamycin hydrochloride XINYU PHARMACEUTICAL CO., LTD. Suzhou City CN R0-CEP 2022-223 - Rev 00 2023/08/21 Valid 21/08/2028 Chemical 2023/08/21 New application|CEP granted|21/08/2023
1792 Nicotine resinate, Nicotine Content 18% with Glycerol 9.0-11.0% NICOBRAND LIMITED Coleraine GB R0-CEP 2022-477 - Rev 00 2023/08/21 Valid 21/08/2028 Chemical 2023/08/21 New application|CEP granted|21/08/2023
1755 Ketorolac trometamol DR. REDDY'S LABORATORIES LIMITED Hyderabad IN R1-CEP 2008-069 - Rev 05 2023/08/21 Valid Chemical 2023/08/21 Minor revision|CEP granted|21/08/2023;
Major revision|CEP granted|21/06/2021;
Minor revision|CEP granted|06/01/2021
2019 Perindopril tert-butylamine APOTEX PHARMACHEM INDIA PVT. LTD Bangalore IN R1-CEP 2010-332 - Rev 03 2023/08/21 Valid Chemical 2023/08/21 Minor revision|CEP granted|21/08/2023;
Monograph revision|Accepted - CEP remains valid|08/04/2020
2443 Fulvestrant TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL R1-CEP 2013-255 - Rev 02 2023/08/21 Valid Chemical 2023/08/21 Minor revision|CEP granted|21/08/2023;
Notification|CEP granted|10/11/2021
1796 Sucralfate ZHEJIANG HAISEN PHARMACEUTICAL CO., LTD. Xiangtan Village CN R0-CEP 2019-185 - Rev 01 2023/08/18 Valid 14/01/2026 Chemical 2023/08/18 Minor revision|CEP granted|18/08/2023
1722 Flunarizine dihydrochloride VASUDHA PHARMA CHEM LIMITED Hyderabad IN R0-CEP 2020-224 - Rev 03 2023/08/18 Valid 01/02/2027 Chemical 2023/08/18 Monograph revision|CEP granted|18/08/2023;
Notification|CEP granted|03/02/2023;
Minor revision|CEP granted|06/07/2022;
New application|CEP granted|01/02/2022
2154 Telmisartan TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL R1-CEP 2010-301 - Rev 04 2023/08/18 Valid Chemical 2023/08/18 Notification|CEP granted|18/08/2023;
Notification|CEP granted|20/12/2021;
Minor revision|CEP granted|24/06/2020
2423 Valsartan MSN LIFE SCIENCES PRIVATE LIMITED Chandampet Village IN R0-CEP 2018-275 - Rev 03 2023/08/17 Valid 09/10/2024 Chemical 2023/08/24 Minor revision|CEP granted|24/08/2023;
Minor revision|CEP granted|18/11/2022;
Minor revision|CEP granted|24/09/2021
2374 Omeprazole magnesium DR. REDDY'S LABORATORIES LIMITED Hyderabad IN R0-CEP 2022-115 - Rev 00 2023/08/17 Valid 17/08/2028 Chemical 2023/08/17 New application|CEP granted|17/08/2023
2191 Atorvastatin calcium, Site 2 ZHEJIANG JIANGBEI NANHAI PHARMACEUTICAL CO., LTD Linhai City CN R0-CEP 2023-160 - Rev 00 2023/08/17 Valid 17/08/2028 Chemical 2023/08/17 New application|CEP granted|17/08/2023
654 Beclometasone dipropionate, Micronised, non micronised TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL R1-CEP 2003-254 - Rev 06 2023/08/17 Valid Chemical 2023/08/17 Notification|CEP granted|17/08/2023;
Notification|CEP granted|04/01/2022;
Minor revision|CEP granted|22/01/2021
1292 Amphotericin B North China Pharmaceutical Huasheng Co., Ltd. Shijiazhuang CN R1-CEP 2005-212 - Rev 04 2023/08/17 Valid Chemical 2024/07/31 Minor revision|Accepted - CEP remains valid|31/07/2024;
Notification|Rejected|28/05/2024;
Minor revision|CEP granted|17/08/2023;
Minor revision|Abandoned|07/06/2023;
Notification|CEP granted|10/11/2020;
Notification|Abandoned|18/09/2020
2606 Tadalafil RAKSHIT PHARMACEUTICALS LIMITED Anakapalli IN R1-CEP 2016-317 - Rev 00 2023/08/17 Valid Chemical 2023/08/17 Renewal|CEP granted|17/08/2023;
Notification|CEP granted|11/01/2023;
Minor revision|Accepted - CEP remains valid|13/04/2021
2593 Docetaxel, Code SPT1298 SCINOPHARM TAIWAN, LTD. Shan-Hua TW R1-CEP 2016-339 - Rev 00 2023/08/17 Valid Chemical 2023/08/17 Renewal|CEP granted|17/08/2023
1783 Glycopyrronium bromide, Micronised, non-micronised Inke, S.A. Castellbisbal ES R1-CEP 2017-182 - Rev 00 2023/08/17 Valid Chemical 2023/08/24 Renewal|CEP granted|24/08/2023;
Minor revision|Accepted - CEP remains valid|02/08/2022;
Minor revision|CEP granted|02/03/2021;
Minor revision|CEP granted|18/05/2020
1187 Carmustine MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN R0-CEP 2017-231 - Rev 03 2023/08/16 Valid 21/06/2024 Chemical 2023/08/16 Notification|CEP granted|16/08/2023

数据库说明:

当前数据更新日期:2024年08月17日。
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