| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2896 | Thiocolchicoside crystallised from ethanol | INDIA GLYCOLS LIMITED Dehradun IN | 100038944;100061244 | CEP 2020-066 - Rev 02 | 2026/01/21 | Valid | 06/04/2027 | Chemical | 2026/01/21 | Minor revision|CEP granted|21/01/2026; Major revision|CEP granted|05/01/2024; New application|CEP granted|06/04/2022 |
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| 1444 | Macrogols, Type 3350 and 4000 | SASOL GERMANY GMBH Marl DE | 100043602;100072176 | CEP 2009-392 - Rev 02 | 2026/01/21 | Valid | Chemical | 2026/01/21 | Notification|CEP granted|21/01/2026; Major revision|CEP granted|06/07/2022 |
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| 2234 | Meropenem trihydrate, Synthetic origin, Sterile, Process II | SHENZHEN HAIBIN PHARMACEUTICAL CO., LTD. Shenzhen City CN | 100021561;100030252 | CEP 2024-097 - Rev 02 | 2026/01/21 | Valid | 11/06/2030 | Chemical | 2026/01/21 | Minor revision|CEP granted|21/01/2026; Administrative procedure|CEP granted|19/08/2025; New application|CEP granted|11/06/2025 |
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| 2409 | Diacerein | RAKSHIT PHARMACEUTICALS LIMITED Anakapalli District IN | 100039283;100061839 | CEP 2024-436 - Rev 00 | 2026/01/21 | Valid | 21/01/2031 | Chemical | 2026/01/21 | New application|CEP granted|21/01/2026 | |
| 2019 | Perindopril tert-butylamine, Crystalline form-α | MSN PHARMACHEM PRIVATE LIMITED Sangareddy IN | 100014794;100023345 | CEP 2025-249 - Rev 00 | 2026/01/21 | Valid | 21/01/2031 | Chemical | 2026/01/21 | New application|CEP granted|21/01/2026 | |
| 45 | Methyldopa, Site Yongtai Chiral, Process A | ZHEJIANG YONGTAI CHIRAL MEDICINE TECHNOLOGY CO. LTD. Taizhou CN | 100041319;100068021 | CEP 2025-526 - Rev 00 | 2026/01/21 | Valid | 21/01/2031 | Chemical | 2026/01/21 | New application|CEP granted|21/01/2026 | |
| 2637 | Pemetrexed disodium heptahydrate | JIANGSU HANSOH PHARMACEUTICAL GROUP CO., LTD. Lianyungang City CN | 100034195;100092374 | CEP 2022-265 - Rev 01 | 2026/01/21 | Valid | 19/06/2028 | Chemical | 2026/01/21 | Minor revision|CEP granted|21/01/2026; Minor revision|Accepted - CEP remains valid|02/10/2024; New application|CEP granted|19/06/2023 |
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| 1575 | Tiapride hydrochloride | ICROM S.R.L. Concorezzo IT | 100022464;100031145 | CEP 2023-003 - Rev 01 | 2026/01/20 | Valid | 19/01/2029 | Chemical | 2026/01/20 | Minor revision|CEP granted|20/01/2026; New application|CEP granted|19/01/2024 |
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| 2896 | Thiocolchicoside crystallised from ethanol | QUAD LIFESCIENCES PRIVATE LIMITED S.A.S Nagar IN | 100050170;100087590 | CEP 2023-103 - Rev 00 | 2026/01/20 | Valid | 20/01/2031 | Chemical | 2026/01/20 | New application|CEP granted|20/01/2026 | |
| 2617 | Aripiprazole | ALKEM LABORATORIES LIMITED Mumbai IN | 100005554;100010367 | CEP 2024-180 - Rev 00 | 2026/01/20 | Valid | 20/01/2031 | Chemical | 2026/01/20 | New application|CEP granted|20/01/2026 | |
| 198 | Oxytetracycline hydrochloride | HEBEI SHENGXUE DACHENG PHARMACEUTICAL CO. LTD. Shijiazhuang CN | 100016575;100025368 | CEP 2021-099 - Rev 02 | 2026/01/20 | Valid | 16/06/2027 | Chemical | 2026/01/20 | Minor revision|CEP granted|20/01/2026; Monograph revision|Accepted - CEP remains valid|23/12/2024; Minor revision|Accepted - CEP remains valid|07/09/2023; Administrative procedure|CEP granted|28/06/2022; New application|CEP granted|20/06/2022 |
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| 68 | Atropine sulfate | RESONANCE LABORATORIES PRIVATE LIMITED Bengaluru IN | 100024014;100033182 | CEP 2023-234 - Rev 00 | 2026/01/19 | Valid | 19/01/2031 | Chemical | 2026/01/19 | New application|CEP granted|19/01/2026 | |
| 2445 | Adapalene | AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN | 100045727;100075371 | CEP 2022-158 - Rev 01 | 2026/01/19 | Valid | 19/06/2029 | Chemical | 2026/01/19 | Minor revision|CEP granted|19/01/2026; New application|CEP granted|19/06/2024 |
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| 1210 | Fentanyl | VERANOVA, L.P. West Deptford US | 100012273;100018937 | CEP 2000-141 - Rev 04 | 2026/01/19 | Valid | Chemical | 2026/01/19 | Minor revision|CEP granted|19/01/2026 | ||
| 110 | Zinc chloride | Merck KGaA Darmstadt DE | 100000742;100006955 | CEP 2014-168 - Rev 03 | 2026/01/19 | Valid | Chemical | 2026/01/19 | Minor revision|CEP granted|19/01/2026; Major revision|CEP granted|03/10/2022; Minor revision|CEP granted|29/11/2021; Renewal|CEP granted|27/10/2020 |
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| 698 | Warfarin sodium | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2009-041 - Rev 03 | 2026/01/19 | Valid | Chemical | 2026/01/19 | Minor revision|CEP granted|19/01/2026; Notification|Accepted - CEP remains valid|23/06/2023; Minor revision|Accepted - CEP remains valid|09/04/2020 |
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| 2762 | Capecitabine | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2014-355 - Rev 05 | 2026/01/19 | Valid | Chemical | 2026/01/19 | Minor revision|CEP granted|19/01/2026; Minor revision|CEP granted|20/05/2025; Minor revision|CEP granted|22/01/2025; Notification|Accepted - CEP remains valid|05/09/2023; Major revision|CEP granted|16/06/2023; Major revision|CEP granted|18/10/2022; Renewal|CEP granted|24/09/2021; Notification|CEP granted|24/07/2020 |
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| . | Bovine Calf Serum | MEDIATECH INC. Manassas US | 100051460;100090205 | CEP 2018-305 - Rev 02 | 2026/01/19 | Valid | TSE | 2026/01/19 | Major revision|CEP granted|19/01/2026; Renewal|CEP granted|03/07/2024 |
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| 2020 | Rilmenidine dihydrogen phosphate | ZENTIVA K.S. Prague CZ | 100004108;100097772 | CEP 2023-124 - Rev 01 | 2026/01/19 | Valid | 18/12/2029 | Chemical | 2026/01/19 | Notification|CEP granted|19/01/2026; New application|CEP granted|19/12/2024 |
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| 2131 | Tamsulosin hydrochloride, Ankleshwar site | ZENTIVA K.S. Prague CZ | 100004108;100097772 | CEP 2023-469 - Rev 01 | 2026/01/19 | Valid | 25/04/2029 | Chemical | 2026/01/19 | Notification|CEP granted|19/01/2026; New application|CEP granted|25/04/2024 |
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