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 |
---|---|---|---|---|---|---|---|---|---|---|---|
1724 | Formoterol fumarate dihydrate | Vamsi Labs Limited Solapur IN | 100014747;100023262 | R1-CEP 2006-227 - Rev 02 | 2022/07/28 | Valid | Chemical | 2023/09/22 | Notification|Accepted - CEP remains valid|22/09/2023; Notification|CEP granted|28/07/2022; Monograph revision|Accepted - CEP remains valid|06/05/2022 |
||
1745 | Carvedilol | SHODHANA LABORATORIES PRIVATE LIMITED Hyderabad IN | 100021550;100030244 | R1-CEP 2008-259 - Rev 01 | 2022/07/28 | Valid | Chemical | 2022/07/28 | Minor revision|CEP granted|28/07/2022 | ||
2420 | Tiotropium bromide monohydrate, Micronised, non-micronised | Vamsi Labs Limited Solapur IN | 100014747;100023262 | R1-CEP 2012-285 - Rev 01 | 2022/07/28 | Valid | Chemical | 2023/09/14 | Notification|Rejected|14/09/2023; Notification|CEP granted|28/07/2022 |
||
2307 | Modafinil | WAVELENGTH ENTERPRISES LTD. Petah Tikva IL | 100018877;100050444 | R1-CEP 2013-213 - Rev 03 | 2022/07/28 | Valid | Chemical | 2022/12/21 | Minor revision|Accepted - CEP remains valid|21/12/2022; Minor revision|CEP granted|28/07/2022; Minor revision|CEP granted|02/11/2021; Notification|CEP granted|10/06/2020 |
||
1558 | Propofol | HARMAN FINOCHEM LIMITED Mumbai IN | 100011528;100020515 | R1-CEP 2015-347 - Rev 00 | 2022/07/28 | Valid | Chemical | 2022/07/28 | Renewal|CEP granted|28/07/2022; Minor revision|CEP granted|02/11/2020 |
||
394 | Hydrochlorothiazide | AMOLI ORGANICS PRIVATE LIMITED Mumbai IN | 100016500;100025303 | R1-CEP 2016-012 - Rev 00 | 2022/07/28 | Valid | Chemical | 2022/07/28 | Renewal|CEP granted|28/07/2022; Minor revision|CEP granted|12/01/2021; Minor revision|CEP granted|03/06/2020 |
||
2191 | Atorvastatin calcium, Process-IV | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | R0-CEP 2021-079 - Rev 01 | 2022/07/27 | Valid | 05/07/2026 | Chemical | 2022/08/01 | Monograph revision|CEP granted|01/08/2022; New application|CEP granted|05/07/2021 |
|
703 | Atenolol, ALA route | KOPRAN RESEARCH LABORATORIES LIMITED Mumbai IN | R0-CEP 2021-479 - Rev 00 | 2022/07/27 | Valid | 27/07/2027 | Chemical | 2022/07/27 | New application|CEP granted|27/07/2022 | ||
2531 | Clopidogrel hydrogen sulfate, Process II | Zhejiang Charioteer Pharmaceutical Co., Ltd. Xianju CN | R0-CEP 2022-063 - Rev 00 | 2022/07/27 | Valid | 27/07/2027 | Chemical | 2022/07/27 | New application|CEP granted|27/07/2022 | ||
729 | Naloxone hydrochloride dihydrate, Process-II | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538 | R0-CEP 2022-118 - Rev 00 | 2022/07/27 | Valid | 27/07/2027 | Chemical | 2022/07/27 | New application|CEP granted|27/07/2022 | |
721 | Ibuprofen | IOL CHEMICALS AND PHARMACEUTICALS LTD Ludhiana IN | 100017919;100037377 | R1-CEP 2008-316 - Rev 05 | 2022/07/27 | Valid | Chemical | 2022/07/27 | Minor revision|CEP granted|27/07/2022; Notification|CEP granted|21/06/2021 |
||
2404 | Drospirenone, Micronised (micro 15) | BAYER AG Leverkusen DE | 100000011;100001505 | R1-CEP 2009-070 - Rev 02 | 2022/07/27 | Valid | Chemical | 2022/07/27 | Minor revision|CEP granted|27/07/2022 | ||
1573 | Sumatriptan succinate | MSN PHARMACHEM PRIVATE LIMITED Pashamylaram Village IN | 100014794 | R1-CEP 2009-096 - Rev 03 | 2022/07/27 | Valid | Chemical | 2022/07/27 | Minor revision|CEP granted|27/07/2022; Minor revision|CEP granted|11/03/2021 |
||
52 | Rifampicin | OLON S.P.A. Rodano IT | 100012085;100019537 | R1-CEP 2009-275 - Rev 04 | 2022/07/27 | Valid | Chemical | 2022/07/27 | Minor revision|CEP granted|27/07/2022; Major revision|CEP granted|24/11/2021 |
||
2191 | Atorvastatin calcium, Process II | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | R1-CEP 2011-156 - Rev 05 | 2022/07/27 | Valid | Chemical | 2022/07/27 | Monograph revision|CEP granted|27/07/2022; Notification|CEP granted|08/07/2022; Minor revision|Rejected|27/01/2021; Major revision|CEP granted|31/03/2020 |
||
2760 | Brimonidine tartrate | Farmak A.S. Olomouc CZ | 100012043;100022687 | R1-CEP 2014-331 - Rev 01 | 2022/07/27 | Valid | Chemical | 2022/07/27 | Minor revision|CEP granted|27/07/2022; Notification|Accepted - CEP remains valid|21/02/2022; Renewal|CEP granted|05/07/2021 |
||
2541 | Quetiapine Fumarate | EGIS Pharmaceuticals PLC Budapest HU | 100001091;100001662 | R1-CEP 2016-049 - Rev 00 | 2022/07/27 | Valid | Chemical | 2023/03/17 | Notification|Accepted - CEP remains valid|17/03/2023; Renewal|CEP granted|27/07/2022; Notification|Accepted - CEP remains valid|10/12/2020 |
||
2191 | Atorvastatin calcium, Process-III | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | R0-CEP 2020-309 - Rev 01 | 2022/07/26 | Valid | Chemical | 2022/07/26 | Monograph revision|CEP granted|26/07/2022; New application|CEP granted|19/02/2021 |
||
39 | Magnesium Hydroxide | ANHUI POLY PHARM. CO., LTD. Anqing CN | R0-CEP 2022-010 - Rev 00 | 2022/07/26 | Valid | 26/07/2027 | Chemical | 2022/07/26 | New application|CEP granted|26/07/2022 | ||
662 | Daunorubicin Hydrochloride | TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL | 100000702;100060842 | R1-CEP 2001-284 - Rev 03 | 2022/07/26 | Valid | Chemical | 2023/02/17 | Monograph revision|Accepted - CEP remains valid|17/02/2023; Minor revision|CEP granted|26/07/2022; Notification|CEP granted|20/12/2021; Notification|Accepted - CEP remains valid|26/06/2020 |