| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 749 | Vincristine sulfate | HUBEI HONCH PHARMACEUTICAL CO., LTD. Huanggang CN | 100036821;100058182 | CEP 2024-264 - Rev 00 | 2025/10/30 | Valid | 30/10/2030 | Chemical | 2025/10/30 | New application|CEP granted|30/10/2025 | |
| 1796 | Sucralfate | ZHEJIANG HAISEN PHARMACEUTICAL CO., LTD. Xiangtan Village CN | 100024637;100033815 | CEP 2019-185 - Rev 02 | 2025/10/30 | Valid | Chemical | 2025/10/30 | Renewal|CEP granted|30/10/2025; Minor revision|Accepted - CEP remains valid|16/01/2025; Minor revision|CEP granted|18/08/2023 |
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| 1448 | Metoprolol succinate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2005-221 - Rev 07 | 2025/10/28 | Valid | Chemical | 2025/10/28 | Notification|CEP granted|28/10/2025; Notification|CEP granted|16/07/2025; Minor revision|Accepted - CEP remains valid|08/12/2023; Minor revision|Accepted - CEP remains valid|21/11/2022; Notification|CEP granted|21/12/2021; Minor revision|CEP granted|14/10/2020 |
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| 1488 | Alprostadil | EVERLIGHT CHEMICAL INDUSTRIAL CORPORATION Taipei TW | 100011679;100020963 | CEP 2012-204 - Rev 02 | 2025/10/28 | Valid | Chemical | 2025/10/28 | Minor revision|CEP granted|28/10/2025; Minor revision|CEP granted|27/06/2022 |
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| 2600 | Olmesartan medoxomil | VIYASH LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100040217;100065484 | CEP 2023-253 - Rev 00 | 2025/10/28 | Valid | 28/10/2030 | Chemical | 2025/10/28 | New application|CEP granted|28/10/2025 | |
| 199 | Oxytetracycline dihydrate | CIPAN - COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS, S.A. Castanheira do Ribatejo PT | 100021412;100078598 | CEP 2024-247 - Rev 00 | 2025/10/28 | Valid | 28/10/2030 | Chemical | 2025/10/28 | New application|CEP granted|28/10/2025 | |
| 1665 | Betahistine dihydrochloride | Grunenthal GmbH Aachen DE | 100000515;100006949 | CEP 2009-001 - Rev 03 | 2025/10/28 | Valid | Chemical | 2025/10/28 | Minor revision|CEP granted|28/10/2025; Minor revision|CEP granted|10/04/2025; Minor revision|Accepted - CEP remains valid|02/10/2024; Minor revision|Accepted - CEP remains valid|03/01/2023; Notification|Accepted - CEP remains valid|14/02/2022 |
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| 369 | Azathioprine | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2023-399 - Rev 00 | 2025/10/28 | Valid | 28/10/2030 | Chemical | 2025/10/28 | New application|CEP granted|28/10/2025 | |
| 2119 | Venlafaxine hydrochloride | ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO., LTD. Dongyang City CN | 100022699;100078733 | CEP 2023-219 - Rev 00 | 2025/10/28 | Valid | 28/10/2030 | Chemical | 2025/10/28 | New application|CEP granted|28/10/2025 | |
| 2234 | Meropenem trihydrate, Sterile, synthetic origin, process II | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2018-268 - Rev 02 | 2025/10/28 | Valid | Chemical | 2025/10/28 | Renewal|CEP granted|28/10/2025; Minor revision|CEP granted|19/12/2022 |
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| 2179 | Pimobendan for Veterinary Use | WISDOM PHARMACEUTICAL CO., LTD. Haimen CN | 100014837;100023467 | CEP 2013-329 - Rev 01 | 2025/10/27 | Valid | Chemical | 2025/10/27 | Minor revision|CEP granted|27/10/2025; Minor revision|Accepted - CEP remains valid|29/06/2021; Renewal|CEP granted|03/05/2021; Minor revision|Accepted - CEP remains valid|30/10/2020 |
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| 1961 | Poly(vinyl alcohol), Viscosity 5.1 mPa.s, Ester value 140 mg KOH/g | MITSUBISHI CHEMICAL CORPORATION Chiyoda JP | 100047136;100077835 | CEP 2013-209 - Rev 01 | 2025/10/27 | Valid | Chemical | 2025/10/27 | Minor revision|CEP granted|27/10/2025; Renewal|CEP granted|28/09/2021; Administrative procedure|CEP granted|13/01/2020 |
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| 977 | Brompheniramine maleate | SUPRIYA LIFESCIENCE LIMITED Mumbai IN | 100015796;100024574 | CEP 2015-097 - Rev 02 | 2025/10/27 | Valid | Chemical | 2025/10/27 | Administrative procedure|CEP granted|27/10/2025; Major revision|CEP granted|14/05/2025; Renewal|CEP granted|19/01/2023 |
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| 2191 | Atorvastatin calcium, Form-I | LAURUS LABS LIMITED Hyderabad IN | 100011702;100032608 | CEP 2021-150 - Rev 02 | 2025/10/27 | Valid | 18/01/2028 | Chemical | 2025/10/27 | Minor revision|CEP granted|27/10/2025; Minor revision|Accepted - CEP remains valid|28/06/2024; Administrative procedure|CEP granted|28/03/2023; New application|CEP granted|19/01/2023 |
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| 2631 | Rosuvastatin calcium, RS02 | CTX LIFESCIENCES PVT. LIMITED Surat IN | 100019102;100027863 | CEP 2025-419 - Rev 00 | 2025/10/27 | Valid | 27/10/2030 | Chemical | 2025/10/27 | New application|CEP granted|27/10/2025 | |
| 2230 | Latanoprost | FDC Limited Mumbai IN | 100011646;100021030 | CEP 2024-162 - Rev 01 | 2025/10/27 | Valid | 17/09/2030 | Chemical | 2025/10/27 | Minor revision|CEP granted|27/10/2025; New application|CEP granted|17/09/2025 |
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| 2778 | Sitagliptin phosphate monohydrate | IOL CHEMICALS AND PHARMACEUTICALS LTD Ludhiana IN | 100017919;100037377 | CEP 2024-063 - Rev 00 | 2025/10/27 | Valid | 27/10/2030 | Chemical | 2025/10/27 | New application|CEP granted|27/10/2025 | |
| 2449 | Docetaxel trihydrate | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2022-149 - Rev 02 | 2025/10/27 | Valid | 07/03/2029 | Chemical | 2025/10/27 | Minor revision|CEP granted|27/10/2025; Minor revision|CEP granted|15/11/2024; New application|CEP granted|07/03/2024 |
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| 1656 | Moxidectin for veterinary use, with butyl hydroxytoluene | HISUN PHARMACEUTICAL (HANGZHOU) CO., LTD. Hangzhou City CN | 100012542;100060684 | CEP 2012-384 - Rev 03 | 2025/10/24 | Valid | Chemical | 2025/10/24 | Minor revision|CEP granted|24/10/2025; Minor revision|CEP granted|13/12/2021 |
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| 1794 | Paclitaxel, Produced by a semi-synthetic process | CHONGQING SINTAHO PHARMACEUTICAL CO., LTD. Maliuzui CN | 100041836;100068984 | CEP 2022-006 - Rev 01 | 2025/10/24 | Valid | 07/02/2028 | Chemical | 2025/10/24 | Minor revision|CEP granted|24/10/2025; New application|CEP granted|07/02/2023 |
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