| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1798 | Trospium chloride | ENALTEC LABS PRIVATE LIMITED Navi Mumbai IN | 100015510;100024234 | R0-CEP 2020-350 - Rev 00 | 2023/02/16 | Valid | 16/02/2028 | Chemical | 2023/02/16 | New application|CEP granted|16/02/2023 | |
| 2849 | Hydroxychloroquine sulfate | ZHUHAI RUNDU PHARMACEUTICAL CO., LTD. Sanzao Town CN | 100033558;100052545 | R0-CEP 2021-317 - Rev 00 | 2023/02/16 | Valid | 16/02/2028 | Chemical | 2023/02/16 | New application|CEP granted|16/02/2023 | |
| 2362 | Rifaximin, [RSA code] Process-II | GRANULES INDIA LIMITED Hyderabad IN | 100011671;100018694 | R0-CEP 2021-377 - Rev 00 | 2023/02/16 | Valid | 16/02/2028 | Chemical | 2023/02/16 | New application|CEP granted|16/02/2023 | |
| 494 | Fluocinolone acetonide, Micronised, non-micronised | Farmabios SpA Gropello Cairoli IT | 100011643;100021232 | R1-CEP 2004-103 - Rev 02 | 2023/02/16 | Valid | Chemical | 2023/02/16 | Minor revision|CEP granted|16/02/2023 | ||
| 320 | Colistin sulfate | NUGENE PHARMA (SHANDONG) CO., LTD. Jining CN | R1-CEP 2005-166 - Rev 01 | 2023/02/16 | Valid | Chemical | 2023/02/16 | Minor revision|CEP granted|16/02/2023 | |||
| 1767 | Tilidine hydrochloride hemihydrate | SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH Minden DE | 100012159 | R1-CEP 2007-045 - Rev 05 | 2023/02/16 | Valid | Chemical | 2023/02/16 | Notification|CEP granted|16/02/2023; Minor revision|Accepted - CEP remains valid|17/11/2020 |
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| 1756 | Lamotrigine | PHARMACEUTICAL WORKS POLPHARMA S.A. Starogard Gdanski PL | 100000470;100001572 | R1-CEP 2010-128 - Rev 02 | 2023/02/16 | Valid | Chemical | 2023/02/16 | Minor revision|CEP granted|16/02/2023; Minor revision|CEP granted|11/03/2020 |
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| 2449 | Docetaxel trihydrate | FRESENIUS KABI ONCOLOGY LIMITED Kalyani IN | 100011513;100018607 | R1-CEP 2011-189 - Rev 04 | 2023/02/16 | Valid | Chemical | 2023/08/18 | Notification|Accepted - CEP remains valid|18/08/2023; Minor revision|CEP granted|16/02/2023; Notification|Rejected|12/01/2023; Minor revision|CEP granted|07/02/2022; Notification|CEP granted|16/12/2020 |
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| 475 | Chlorpromazine hydrochloride | MAITHRI LABORATORIES PRIVATE LIMITED Gaddapotharam Village IN | 100013041;100021615 | R0-CEP 2021-018 - Rev 02 | 2023/02/15 | Valid | 01/08/2027 | Chemical | 2023/02/15 | Notification|CEP granted|15/02/2023; Administrative procedure|CEP granted|30/08/2022; New application|CEP granted|01/08/2022 |
|
| 2781 | Tolterodine tartrate | MAITHRI LABORATORIES PRIVATE LIMITED Gaddapotharam Village IN | 100013041;100021615 | R0-CEP 2021-020 - Rev 01 | 2023/02/15 | Valid | 20/06/2027 | Chemical | 2023/02/15 | Notification|CEP granted|15/02/2023; New application|CEP granted|20/06/2022 |
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| 197 | Neomycin sulfate, Site 2 | Yichang Sanxia Pharmaceutical Co., Ltd. Yichang CN | R0-CEP 2022-013 - Rev 01 | 2023/02/15 | Valid | 29/04/2027 | Chemical and TSE | 2023/02/15 | Notification|CEP granted|15/02/2023; New application|CEP granted|29/04/2022 |
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| 627 | Nifedipine | Unique Chemicals (A Division of J.B. Chemicals & Pharmaceuticals Ltd.) Mumbai IN | R1-CEP 2000-096 - Rev 05 | 2023/02/15 | Valid | Chemical | 2023/02/15 | Minor revision|CEP granted|15/02/2023; Minor revision|Accepted - CEP remains valid|15/04/2020 |
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| 1680 | Pyrantel embonate | MEGAFINE PHARMA (P) LIMITED Mumbai IN | R1-CEP 2006-162 - Rev 02 | 2023/02/15 | Valid | Chemical | 2023/02/15 | Minor revision|CEP granted|15/02/2023; Minor revision|CEP granted|18/05/2021; Monograph revision|Accepted - CEP remains valid|24/04/2020 |
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| 1790 | Naltrexone hydrochloride | SIEGFRIED LTD. Zofingen CH | 100022117 | R1-CEP 2009-352 - Rev 03 | 2023/02/15 | Valid | Chemical | 2023/02/15 | Major revision|CEP granted|15/02/2023; Minor revision|Accepted - CEP remains valid|19/02/2021 |
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| 2591 | Celecoxib | MYLAN LABORATORIES LIMITED Hyderabad IN | 100011537;100018667 | R1-CEP 2012-183 - Rev 03 | 2023/02/15 | Valid | Chemical | 2023/02/15 | Minor revision|CEP granted|15/02/2023; Minor revision|CEP granted|26/09/2022 |
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| 2589 | Abacavir sulfate | LAURUS LABS LIMITED Hyderabad IN | 100011702;100032608 | R1-CEP 2014-353 - Rev 01 | 2023/02/15 | Valid | Chemical | 2023/02/15 | Major revision|CEP granted|15/02/2023; Renewal|CEP granted|12/04/2021; Major revision|CEP granted|09/06/2020 |
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| 1520 | Foscarnet sodium hexahydrate | Chemwerth, Inc. Woodbridge US | R0-CEP 2020-337 - Rev 00 | 2023/02/14 | Valid | 14/02/2028 | Chemical | 2023/02/14 | New application|CEP granted|14/02/2023 | ||
| 1793 | Oxycodone hydrochloride | SPECGX LLC Webster Groves US | 100017269;100031662 | R0-CEP 2021-375 - Rev 00 | 2023/02/14 | Valid | 14/02/2028 | Chemical | 2023/02/14 | New application|CEP granted|14/02/2023 | |
| 929 | Loperamide hydrochloride | LAKE CHEMICALS PRIVATE LIMITED Shivaji Nagar IN | 100012055;100053935 | R1-CEP 2009-362 - Rev 02 | 2023/02/14 | Valid | Chemical | 2023/02/14 | Notification|CEP granted|14/02/2023 | ||
| 1256 | RRR-alpha-Tocopherol | ARCHER DANIELS MIDLAND COMPANY Decatur US | 100025474 | R1-CEP 2016-184 - Rev 00 | 2023/02/14 | Valid | Chemical | 2023/02/14 | Renewal|CEP granted|14/02/2023 |
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