| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1699 | Mesalazine | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | R1-CEP 2003-267 - Rev 06 | 2023/02/20 | Valid | Chemical | 2023/02/20 | Minor revision|CEP granted|20/02/2023 | ||
| 992 | Cefuroxime sodium, Sterile | NECTAR LIFESCIENCES LIMITED Tehsil Dera Bassi IN | 100019097;100029430 | R1-CEP 2011-062 - Rev 01 | 2023/02/20 | Valid | Chemical | 2023/02/20 | Minor revision|CEP granted|20/02/2023 | ||
| 979 | Calcium gluconate for injection | Zhejiang Ruibang Laboratories Wenzhou CN | R1-CEP 2012-068 - Rev 01 | 2023/02/20 | Valid | Chemical | 2023/02/20 | Monograph revision|CEP granted|20/02/2023 | |||
| 627 | Nifedipine | IPCA Laboratories Limited Mumbai IN | 100011685;100018680 | R1-CEP 2014-102 - Rev 01 | 2023/02/20 | Valid | Chemical | 2023/02/20 | Minor revision|CEP granted|20/02/2023; Minor revision|Accepted - CEP remains valid|08/11/2021; Renewal|CEP granted|13/01/2021 |
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| 937 | Minoxidil | VPL CHEMICALS PRIVATE LIMITED Bangalore rural IN | R0-CEP 2018-244 - Rev 01 | 2023/02/17 | Valid | 02/01/2025 | Chemical | 2023/02/17 | Notification|CEP granted|17/02/2023 | ||
| 2617 | Aripiprazole | TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL | 100000702;100060842 | R0-CEP 2018-267 - Rev 02 | 2023/02/17 | Valid | 22/07/2025 | Chemical | 2023/02/17 | Major revision|CEP granted|17/02/2023; Notification|CEP granted|23/09/2021; Monograph revision|Accepted - CEP remains valid|13/04/2021 |
|
| 1413 | Dequalinium chloride | Laboratorios Espinos Y Bofill S.A. (LEBSA) Cornellà ES | 100021595;100030302 | R0-CEP 2019-026 - Rev 02 | 2023/02/17 | Valid | 18/12/2025 | Chemical | 2023/02/17 | Monograph revision|CEP granted|17/02/2023; Administrative procedure|CEP granted|15/04/2021; Minor revision|Accepted - CEP remains valid|29/03/2021 |
|
| 2331 | Rabeprazole sodium hydrate, Y-Form | METROCHEM API PRIVATE LIMITED Hyderabad IN | 100074519 | R0-CEP 2022-468 - Rev 00 | 2023/02/17 | Valid | 17/02/2028 | Chemical | 2023/02/17 | New application|CEP granted|17/02/2023 | |
| 2110 | Isradipine | MAGLE CHEMOSWED AB Malmö SE | R1-CEP 2007-303 - Rev 03 | 2023/02/17 | Valid | Chemical | 2023/02/17 | Monograph revision|CEP granted|17/02/2023 | |||
| 1691 | Dacarbazine | SUZHOU LIXIN PHARMACEUTICAL CO., LTD. Suzhou CN | 100012102;100019568 | R1-CEP 2010-315 - Rev 02 | 2023/02/17 | Valid | Chemical | 2024/04/11 | Minor revision|Accepted - CEP remains valid|11/04/2024; Minor revision|CEP granted|17/02/2023; Monograph revision|Accepted - CEP remains valid|25/06/2021; Minor revision|Accepted - CEP remains valid|26/05/2020 |
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| 2416 | Pramipexole dihydrochloride monohydrate | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | R1-CEP 2010-328 - Rev 03 | 2023/02/17 | Valid | Chemical | 2023/02/17 | Minor revision|CEP granted|17/02/2023; Minor revision|Accepted - CEP remains valid|11/08/2021 |
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| 2604 | Ropinirole hydrochloride | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Linhai CN | 100011833;100018698 | R1-CEP 2017-026 - Rev 00 | 2023/02/17 | Valid | Chemical | 2023/02/17 | Renewal|CEP granted|17/02/2023; Minor revision|CEP granted|21/12/2020 |
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| 2173 | Gabapentin, Process II | Jiangxi Synergy Pharmaceutical Co., Ltd. Fengxin CN | 100020812;100083553 | R0-CEP 2019-343 - Rev 01 | 2023/02/16 | Valid | 15/05/2025 | Chemical | 2023/02/16 | Minor revision|CEP granted|16/02/2023; Minor revision|Accepted - CEP remains valid|28/04/2022; Minor revision|Accepted - CEP remains valid|23/11/2021 |
|
| 2303 | Adrenaline | WUHAN WUYAO PHARMACEUTICAL CO., LTD. Huangshi City CN | 100022200;100030902 | R0-CEP 2020-192 - Rev 02 | 2023/02/16 | Valid | 11/08/2026 | Chemical | 2023/02/16 | Monograph revision|CEP granted|16/02/2023; Notification|CEP granted|15/07/2022; New application|CEP granted|11/08/2021 |
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| 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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