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 |