| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 194 | Sodium dihydrogen phosphate dihydrate | QUALITY CHEMICALS S.L. Esparreguera ES | 100025665;100034895 | CEP 2017-177 - Rev 02 | 2023/09/26 | Valid | Chemical | 2023/09/26 | Renewal|CEP granted|26/09/2023; Minor revision|CEP granted|15/09/2021 |
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| 333 | Heparin sodium | SHENZHEN HEPALINK PHARMACEUTICAL GROUP CO., LTD. Shenzhen City CN | 100012154;100018639 | CEP 2006-059 - Rev 16 | 2023/09/26 | Valid | Chemical | 2023/09/26 | Major revision|CEP granted|26/09/2023; Minor revision|CEP granted|21/02/2023; Major revision|CEP granted|31/03/2021; Minor revision|CEP granted|28/10/2020; Minor revision|CEP granted|21/04/2020 |
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| 401 | Levothyroxine sodium, Code 460 187 - Code 460 132 | SANDOZ GMBH Kundl AT | 100000546;100000450 | CEP 1998-141 - Rev 11 | 2023/09/26 | Valid | Chemical | 2023/09/26 | Notification|CEP granted|26/09/2023; Major revision|CEP granted|02/06/2022 |
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| 394 | Hydrochlorothiazide, Process III | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2012-044 - Rev 02 | 2023/09/26 | Valid | Chemical | 2023/09/26 | Minor revision|CEP granted|26/09/2023; Major revision|CEP granted|28/11/2022 |
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| 1075 | Budesonide, Process 2, non-micronised and micronised | FERMION OY Espoo FI | 100011508;100020280 | CEP 2023-192 - Rev 00 | 2023/09/26 | Valid | 26/09/2028 | Chemical | 2023/09/26 | New application|CEP granted|26/09/2023 | |
| 2097 | Mebeverine hydrochloride | SYNTHOKEM LABS PRIVATE LIMITED Hyderabad IN | 100018775;100027570 | CEP 2021-271 - Rev 00 | 2023/09/25 | Valid | 25/09/2028 | Chemical | 2023/09/25 | New application|CEP granted|25/09/2023 | |
| 2064 | Chondroitin sulfate sodium | BIOIBERICA, S.A.U. Palafolls ES | 100000136;100043853 | CEP 2023-243 - Rev 00 | 2023/09/25 | Valid | 25/09/2028 | Chemical and TSE | 2023/09/25 | New application|CEP granted|25/09/2023 | |
| 2422 | Oseltamivir phosphate | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2018-046 - Rev 01 | 2023/09/25 | Valid | 28/04/2025 | Chemical | 2023/09/25 | Minor revision|CEP granted|25/09/2023; Minor revision|Accepted - CEP remains valid|05/01/2022 |
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| 2270 | Sildenafil citrate | Zhejiang Jiuzhou Pharmaceutical Co., Ltd. Taizhou City CN | 100011841;100018560 | CEP 2013-332 - Rev 04 | 2023/09/22 | Valid | Chemical | 2023/09/22 | Administrative procedure|CEP granted|22/09/2023; Notification|CEP granted|21/06/2023; Notification|CEP granted|23/09/2022; Transfer of holdership|CEP granted|19/05/2022; Renewal|CEP granted|22/02/2022 |
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| 2675 | Irinotecan hydrochloride trihydrate | FERMION OY Espoo FI | 100011508;100020280 | CEP 2017-236 - Rev 02 | 2023/09/22 | Valid | Chemical | 2023/09/22 | Renewal|CEP granted|22/09/2023 | ||
| 1758 | Moxonidine | Farmak A.S. Olomouc CZ | 100012043;100022687 | CEP 2008-266 - Rev 03 | 2023/09/22 | Valid | Chemical | 2023/09/22 | Major revision|CEP granted|22/09/2023 | ||
| 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 | |
| 996 | Clindamycin phosphate | ZHEJIANG TIANTAI PHARMACEUTICAL CO., LTD. Taizhou City CN | 100011852;100018559 | CEP 2003-060 - Rev 06 | 2023/09/22 | Valid | Chemical | 2023/09/22 | Minor revision|CEP granted|22/09/2023; Notification|Accepted - CEP remains valid|18/11/2021; Minor revision|Accepted - CEP remains valid|23/06/2020 |
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| 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 | Chemical | 2023/09/20 | Minor revision|CEP granted|20/09/2023; New application|CEP granted|13/07/2021 |
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| 1352 | Omega-3-acid triglycerides, SF07200, with tocopherols | CRODA EUROPE LIMITED Leek GB | 100015909;100024641 | CEP 2007-366 - Rev 02 | 2023/09/20 | Valid | Chemical | 2023/09/20 | Minor revision|CEP granted|20/09/2023; Monograph revision|Accepted - CEP remains valid|15/12/2020 |
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