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 |
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2675 | Irinotecan hydrochloride trihydrate | FERMION OY Espoo FI | 100011508;100020280 | CEP 2017-236 - Rev 02 | 2023/09/22 | Valid | Chemical | 2024/04/19 | Notification|Accepted - CEP remains valid|19/04/2024; Renewal|CEP granted|22/09/2023 |
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1758 | Moxonidine | Farmak A.S. Olomouc CZ | 100012043;100022687 | CEP 2008-266 - Rev 03 | 2023/09/22 | Valid | Chemical | 2024/08/02 | Minor revision|Accepted - CEP remains valid|02/08/2024; Major revision|CEP granted|22/09/2023 |
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115 | Benzylpenicillin (procaine) monohydrate, Lecithin coated (1%), sterile | SANDOZ GMBH Kundl AT | 100000546;100000450 | CEP 1999-017 - Rev 05 | 2023/09/22 | Valid | Chemical | 2023/09/22 | Minor revision|CEP granted|22/09/2023; Minor revision|Accepted - CEP remains valid|28/07/2022 |
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2790 | Clopidogrel besilate | MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN | 100011732;100018657 | CEP 2017-143 - Rev 02 | 2023/09/22 | Valid | Chemical | 2023/09/22 | Renewal|CEP granted|22/09/2023 | ||
2223 | Glimepiride, Process-II | GLENMARK LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2022-481 - Rev 00 | 2023/09/22 | Valid | 22/09/2028 | Chemical | 2023/09/22 | New application|CEP granted|22/09/2023 | |
227 | Lidocaine hydrochloride monohydrate | SOCIETÀ ITALIANA MEDICINALI SCANDICCI S.I.M.S. S.R.L Reggello IT | 100012503;100022784 | CEP 2001-014 - Rev 04 | 2023/09/22 | Valid | Chemical | 2023/09/22 | Minor revision|CEP granted|22/09/2023 | ||
1422 | Etodolac | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2008-175 - Rev 04 | 2023/09/21 | Valid | Chemical | 2023/09/21 | Minor revision|CEP granted|21/09/2023; Notification|Accepted - CEP remains valid|26/06/2023; Minor revision|CEP granted|22/10/2021; Minor revision|Accepted - CEP remains valid|21/02/2020 |
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1649 | Azithromycin | Nexchem Pharmaceutical Co., Ltd. Jinhua City CN | 100021355;100036732 | CEP 2021-069 - Rev 00 | 2023/09/20 | Valid | 20/09/2028 | Chemical | 2023/09/20 | New application|CEP granted|20/09/2023 | |
2778 | Sitagliptin phosphate monohydrate | ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN | 100012174;100018701 | CEP 2020-037 - Rev 01 | 2023/09/20 | Valid | 13/07/2026 | Chemical | 2023/09/20 | Minor revision|CEP granted|20/09/2023; New application|CEP granted|13/07/2021 |
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394 | Hydrochlorothiazide | SUZHOU LIXIN PHARMACEUTICAL CO., LTD. Suzhou CN | 100012102;100019568 | CEP 2012-250 - Rev 02 | 2023/09/20 | Valid | Chemical | 2023/09/20 | Minor revision|CEP granted|20/09/2023; Minor revision|CEP granted|14/02/2023; Notification|Rejected|14/12/2022 |
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1705 | Sertraline hydrochloride, Form-II, Process-II | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2014-195 - Rev 02 | 2023/09/20 | Valid | Chemical | 2023/09/20 | Minor revision|CEP granted|20/09/2023; Minor revision|CEP granted|24/05/2022; Renewal|CEP granted|08/09/2020 |
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2573 | Candesartan cilexetil | Jiangxi Synergy Pharmaceutical Co., Ltd. Fengxin CN | 100020812;100083553 | CEP 2013-007 - Rev 03 | 2023/09/20 | Valid | Chemical | 2023/09/20 | Notification|CEP granted|20/09/2023; Notification|CEP granted|21/03/2023; Minor revision|Accepted - CEP remains valid|01/09/2021; Minor revision|CEP granted|24/11/2020; Notification|Abandoned|09/10/2020 |
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821 | Estradiol hemihydrate, Micronised fine, non-micronised | VALDEPHARM Val de Reuil FR | 100011898;100018788 | CEP 2009-241 - Rev 06 | 2023/09/20 | Valid | Chemical | 2023/09/20 | Major revision|CEP granted|20/09/2023; Minor revision|CEP granted|25/05/2022; Minor revision|CEP granted|06/10/2020 |
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2125 | Doxazosin mesilate | MIDAS PHARMA GMBH Ingelheim am Rhein DE | 100001328;100004656 | CEP 2017-111 - Rev 03 | 2023/09/20 | Valid | Chemical | 2023/09/20 | Renewal|CEP granted|20/09/2023; Notification|CEP granted|21/05/2021 |
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260 | Amoxicillin trihydrate, Powder and for Direct Compression | SANDOZ GMBH Kundl AT | 100000546;100000450 | CEP 2023-277 - Rev 00 | 2023/09/18 | Valid | 18/09/2028 | Chemical | 2024/07/02 | Minor revision|Accepted - CEP remains valid|02/07/2024; Notification|Accepted - CEP remains valid|02/04/2024; New application|CEP granted|18/09/2023 |
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755 | Carbidopa | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2022-358 - Rev 00 | 2023/09/18 | Valid | 18/09/2028 | Chemical | 2023/09/18 | New application|CEP granted|18/09/2023 | |
2287 | Fluconazole | VIRUPAKSHA ORGANICS LIMITED Hyderabad IN | 100021606;100076961 | CEP 2009-364 - Rev 01 | 2023/09/18 | Valid | Chemical | 2023/09/18 | Minor revision|CEP granted|18/09/2023 | ||
1756 | Lamotrigine | TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL | 100000702;100060842 | CEP 2011-178 - Rev 03 | 2023/09/18 | Valid | Chemical | 2023/09/18 | Minor revision|CEP granted|18/09/2023; Notification|CEP granted|20/12/2021; Notification|CEP granted|20/05/2021 |
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68 | Atropine sulfate | MINSHENG GROUP SHAOXING PHARMACEUTICAL CO., LTD. Shaoxing CN | 100023459;100032595 | CEP 2016-112 - Rev 05 | 2023/09/18 | Valid | Chemical | 2023/09/18 | Administrative procedure|CEP granted|18/09/2023; Renewal|CEP granted|12/09/2023; Minor revision|CEP granted|29/06/2022 |
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3014 | Rotigotine | WAVELENGTH ENTERPRISES LTD. Petah Tikva IL | 100018877;100050444 | CEP 2021-291 - Rev 01 | 2023/09/18 | Valid | 25/08/2028 | Chemical | 2024/04/30 | Minor revision|Accepted - CEP remains valid|30/04/2024; Administrative procedure|CEP granted|18/09/2023; New application|CEP granted|25/08/2023 |