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
227 Lidocaine hydrochloride monohydrate CHEMINO PHARMA LIMITED Mumbai IN 100049314;100083804 CEP 2021-084 - Rev 00 2024/08/14 Valid 14/08/2029 Chemical 2024/08/14 New application|CEP granted|14/08/2024
2591 Celecoxib, Process-III, Form-III AMOLI ORGANICS PRIVATE LIMITED Mumbai IN 100016500;100025303 CEP 2024-200 - Rev 00 2024/08/14 Valid 14/08/2029 Chemical 2024/08/14 New application|CEP granted|14/08/2024
68 Atropine sulfate C-SQUARED PHARMA LIMITED Cork IE 100045238;100077698 CEP 2016-216 - Rev 02 2024/08/14 Valid Chemical 2024/08/14 Notification|CEP granted|14/08/2024;
Minor revision|Accepted - CEP remains valid|11/01/2024;
Notification|CEP granted|03/02/2023;
Renewal|CEP granted|26/07/2022;
Minor revision|Accepted - CEP remains valid|28/02/2020
720 Homatropine Methylbromide C-SQUARED PHARMA LIMITED Cork IE 100045238;100077698 CEP 2016-248 - Rev 01 2024/08/14 Valid Chemical 2024/08/14 Notification|CEP granted|14/08/2024;
Minor revision|Accepted - CEP remains valid|27/10/2023;
Renewal|CEP granted|26/01/2023
500 Homatropine Hydrobromide C-SQUARED PHARMA LIMITED Cork IE 100045238;100077698 CEP 2020-115 - Rev 02 2024/08/14 Valid 28/10/2027 Chemical 2024/08/14 Notification|CEP granted|14/08/2024;
Notification|CEP granted|13/02/2023;
New application|CEP granted|28/10/2022
79 Digoxin C-SQUARED PHARMA LIMITED Cork IE 100045238;100077698 CEP 2010-042 - Rev 06 2024/08/14 Valid Chemical 2024/08/14 Notification|CEP granted|14/08/2024;
Minor revision|CEP granted|05/01/2023;
Minor revision|CEP granted|12/07/2021;
Minor revision|CEP granted|25/02/2021
1324 Flecainide acetate EMCURE PHARMACEUTICALS LIMITED Pune IN 100011677;100022690 CEP 2018-155 - Rev 03 2024/08/14 Valid 15/05/2025 Chemical 2024/08/14 Minor revision|CEP granted|14/08/2024;
Minor revision|CEP granted|26/10/2023;
Minor revision|CEP granted|19/05/2022
1075 Budesonide SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2018-064 - Rev 01 2024/08/14 Valid Chemical 2024/08/14 Renewal|CEP granted|14/08/2024
1787 Levomethadone hydrochloride PIONEER AGRO INDUSTRIES SANVIN LABORATORIES PRIVATE LIMITED Mumbai IN 100014944;100038683 CEP 2013-358 - Rev 02 2024/08/14 Valid Chemical 2024/08/14 Minor revision|CEP granted|14/08/2024;
Notification|CEP granted|02/10/2023;
Renewal|CEP granted|29/03/2021
1444 Macrogols, Type 3350 CLARIANT CHEMICALS (HUIZHOU) LTD. Huizhou CN 100045941;100075763 CEP 2020-432 - Rev 01 2024/08/13 Valid 20/01/2028 Chemical 2024/08/13 Minor revision|CEP granted|13/08/2024;
Notification|Accepted - CEP remains valid|05/07/2023;
New application|CEP granted|20/01/2023
2577 Oxcarbazepine CTX LIFESCIENCES PVT. LIMITED Surat IN 100019102;100027863 CEP 2018-113 - Rev 02 2024/08/13 Valid Chemical 2024/08/13 Renewal|CEP granted|13/08/2024;
Minor revision|Accepted - CEP remains valid|31/07/2023;
Minor revision|CEP granted|17/01/2023
603 Disulfiram, Milled ZAKŁADY FARMACEUTYCZNE POLPHARMA S.A. Starogard Gdański PL 100000470;100001572 CEP 2022-090 - Rev 00 2024/08/13 Valid 13/08/2029 Chemical 2024/08/13 New application|CEP granted|13/08/2024
2423 Valsartan SMILAX LABORATORIES LIMITED Hyderabad IN 100011578;100021649 CEP 2023-166 - Rev 00 2024/08/13 Valid 13/08/2029 Chemical 2024/08/13 New application|CEP granted|13/08/2024
1076 Bumetanide OLON S.P.A. Rodano IT 100012085;100019537 CEP 1998-151 - Rev 07 2024/08/13 Valid Chemical 2024/08/13 Minor revision|CEP granted|13/08/2024;
Monograph revision|Accepted - CEP remains valid|02/02/2022;
Minor revision|CEP granted|01/07/2021
49 Paracetamol FARMSON BASIC DRUGS PRIVATE LIMITED Vadodara IN 100052301;100092105 CEP 2002-020 - Rev 11 2024/08/13 Valid Chemical 2024/08/13 Notification|CEP granted|13/08/2024;
Notification|Accepted - CEP remains valid|26/01/2024;
Notification|CEP granted|27/09/2023;
Notification|Rejected|08/08/2023;
Monograph revision|Accepted - CEP remains valid|16/06/2022;
Minor revision|CEP granted|06/01/2022;
Notification|Rejected|02/11/2021;
Notification|Accepted - CEP remains valid|06/04/2021;
Notification|CEP granted|15/10/2020;
Notification|Rejected|08/09/2020
101 Nitrofurantoin, Anhydrate form-β ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2023-364 - Rev 00 2024/08/12 Valid 12/08/2029 Chemical 2024/08/12 New application|CEP granted|12/08/2024
562 Sodium cromoglicate MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2023-048 - Rev 00 2024/08/12 Valid 12/08/2029 Chemical 2024/08/12 New application|CEP granted|12/08/2024
3139 Brivaracetam MAITHRI LABORATORIES PRIVATE LIMITED Gaddapotharam Village IN 100013041;100021615 CEP 2024-061 - Rev 00 2024/08/12 Valid 12/08/2029 Chemical 2024/08/12 New application|CEP granted|12/08/2024
405 Peppermint oil, Double rectified FREY + LAU GMBH Henstedt-Ulzburg DE 100017333;100026131 CEP 2018-043 - Rev 01 2024/08/09 Valid Herbal 2024/08/09 Renewal|CEP granted|09/08/2024;
Notification|Accepted - CEP remains valid|13/08/2021
405 Peppermint oil, Rectified FREY + LAU GMBH Henstedt-Ulzburg DE 100017333;100026131 CEP 2018-042 - Rev 01 2024/08/09 Valid Herbal 2024/08/09 Renewal|CEP granted|09/08/2024;
Notification|Accepted - CEP remains valid|13/08/2021

数据库说明:

当前数据更新日期:2024年08月17日。
©2006-2024 DrugFuture->Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM