| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2119 | Venlafaxine hydrochloride, Process II | QUIMICA SINTETICA S.A. Alcala De Henares ES | 100012121;100019020 | CEP 2021-131 - Rev 01 | 2026/02/23 | Valid | Chemical | 2026/02/23 | Renewal|CEP granted|23/02/2026; New application|CEP granted|01/06/2021 |
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| 1722 | Flunarizine dihydrochloride | HIKAL LIMITED Bengaluru IN | 100014769;100023445 | CEP 2019-094 - Rev 03 | 2026/02/23 | Valid | Chemical | 2026/02/23 | Renewal|CEP granted|23/02/2026; Monograph revision|CEP granted|27/10/2023; Notification|CEP granted|14/09/2022 |
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| 2414 | Octreotide | BACHEM AG Bubendorf CH | 100011626;100021354 | CEP 2020-229 - Rev 02 | 2026/02/23 | Valid | Chemical | 2026/02/23 | Renewal|CEP granted|23/02/2026; Minor revision|CEP granted|18/07/2022; New application|CEP granted|31/03/2021 |
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| 1700 | Mycophenolate mofetil, Process II | RPG LIFE SCIENCES LIMITED Navi Mumbai IN | 100017119;100025920 | CEP 2025-548 - Rev 00 | 2026/02/23 | Valid | 23/02/2031 | Chemical | 2026/02/23 | New application|CEP granted|23/02/2026 | |
| 2790 | Clopidogrel besilate | IOL CHEMICALS AND PHARMACEUTICALS LIMITED Ludhiana IN | 100017919;100037377 | CEP 2024-570 - Rev 00 | 2026/02/23 | Valid | 23/02/2031 | Chemical | 2026/02/23 | New application|CEP granted|23/02/2026 | |
| 645 | Tobramycin | LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN | 100020920;100029633 | CEP 2020-394 - Rev 03 | 2026/02/23 | Valid | 12/07/2027 | Chemical | 2026/02/23 | Minor revision|CEP granted|23/02/2026; Monograph revision|Accepted - CEP remains valid|21/01/2026; Minor revision|CEP granted|22/01/2025; Minor revision|Accepted - CEP remains valid|04/08/2023; Minor revision|CEP granted|02/02/2023; New application|CEP granted|12/07/2022 |
|
| 521 | Phenytoin sodium, Micronised, non-micronised | KATWIJK CHEMIE BV Katwijk ZH NL | 100019011;100027776 | CEP 2015-151 - Rev 01 | 2026/02/23 | Valid | Chemical | 2026/02/23 | Minor revision|CEP granted|23/02/2026; Renewal|CEP granted|14/10/2020 |
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| 1585 | Acamprosate calcium | EMCURE PHARMACEUTICALS LIMITED Pune IN | 100011677;100099996 | CEP 2024-426 - Rev 00 | 2026/02/23 | Valid | 23/02/2031 | Chemical | 2026/02/23 | New application|CEP granted|23/02/2026 | |
| 2306 | Gemcitabine hydrochloride, Process III | INTAS PHARMACEUTICALS LIMITED Ahmedabad IN | 100011529;100023432 | CEP 2022-092 - Rev 03 | 2026/02/23 | Valid | 13/07/2027 | Chemical | 2026/02/23 | Minor revision|CEP granted|23/02/2026; Minor revision|CEP granted|26/05/2025; Minor revision|CEP granted|02/09/2024; Minor revision|Accepted - CEP remains valid|07/11/2023; Notification|Rejected|08/09/2023; New application|CEP granted|13/07/2022 |
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| 1324 | Flecainide acetate, FLI | EMCURE PHARMACEUTICALS LIMITED Pune IN | 100011677;100099996 | CEP 2025-458 - Rev 00 | 2026/02/20 | Valid | 20/02/2031 | Chemical | 2026/02/20 | New application|CEP granted|20/02/2026 | |
| 890 | Clonazepam | R.L. FINE CHEM PRIVATE LIMITED Chikkaballapur IN | 100016723;100053383 | CEP 2023-053 - Rev 01 | 2026/02/20 | Valid | 26/02/2030 | Chemical | 2026/02/20 | Monograph revision|CEP granted|20/02/2026; New application|CEP granted|26/02/2025 |
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| 1694 | Gemfibrozil | HIKAL LIMITED Bengaluru IN | 100014769;100023445 | CEP 2007-089 - Rev 06 | 2026/02/19 | Valid | Chemical | 2026/02/19 | Minor revision|CEP granted|19/02/2026; Minor revision|Accepted - CEP remains valid|23/01/2023; Notification|Rejected|06/12/2022; Notification|CEP granted|07/09/2022; Minor revision|Accepted - CEP remains valid|20/02/2020 |
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| 562 | Sodium cromoglicate | SANOFI AVENTIS SINGAPORE PTE LTD Singapore SG | 100005144;100008271 | CEP 2001-421 - Rev 04 | 2026/02/19 | Valid | Chemical | 2026/02/19 | Notification|CEP granted|19/02/2026; Minor revision|Accepted - CEP remains valid|10/08/2022; Monograph revision|Accepted - CEP remains valid|16/06/2021 |
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| 1096 | Doxepin hydrochloride | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 1999-197 - Rev 06 | 2026/02/19 | Valid | Chemical | 2026/02/19 | Major revision|CEP granted|19/02/2026; Minor revision|CEP granted|07/05/2025; Minor revision|Accepted - CEP remains valid|26/06/2023; Minor revision|CEP granted|08/12/2021; Minor revision|Accepted - CEP remains valid|12/06/2020 |
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| 568 | Propranolol hydrochloride | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2002-026 - Rev 07 | 2026/02/19 | Valid | Chemical | 2026/02/19 | Minor revision|CEP granted|19/02/2026; Minor revision|CEP granted|06/12/2023; Notification|CEP granted|03/08/2023; Minor revision|CEP granted|22/05/2023; Minor revision|Accepted - CEP remains valid|15/07/2022; Minor revision|CEP granted|21/09/2021; Minor revision|Accepted - CEP remains valid|01/04/2021; Minor revision|Accepted - CEP remains valid|13/03/2020 |
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| 576 | Allopurinol | EXEMED PHARMACEUTICALS Vadodara IN | 100019154;100027915 | CEP 2021-331 - Rev 01 | 2026/02/19 | Valid | 30/11/2027 | Chemical | 2026/02/19 | Minor revision|CEP granted|19/02/2026; Notification|Rejected|26/11/2025; New application|CEP granted|01/12/2022 |
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| 3087 | Ticagrelor | ZHEJIANG HISUN PHARMACEUTICAL CO., LTD. Taizhou City CN | 100011825;100018687 | CEP 2024-020 - Rev 00 | 2026/02/19 | Valid | 19/02/2031 | Chemical | 2026/02/19 | New application|CEP granted|19/02/2026 | |
| 1792 | Nicotine resinate, Nicotine content 18% with glycerol 9.0-11.0% | ALCHEM INTERNATIONAL PRIVATE LIMITED Faridabad IN | 100011947;100018683 | CEP 2019-030 - Rev 03 | 2026/02/19 | Valid | Chemical | 2026/02/19 | Minor revision|CEP granted|19/02/2026; Renewal|Accepted - CEP remains valid|17/10/2025; Minor revision|CEP granted|19/05/2025; Minor revision|CEP granted|01/08/2022; Notification|Rejected|23/02/2022 |
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| 2858 | Mometasone furoate monohydrate, Micronised and non-micronised | BREATHGREEN PHARMACEUTICAL CO. LTD. Zaozhuang CN | 100048781;100081153 | CEP 2025-357 - Rev 00 | 2026/02/19 | Valid | 19/02/2031 | Chemical | 2026/02/19 | New application|CEP granted|19/02/2026 | |
| 2606 | Tadalafil | SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO., LTD. Dezhou CN | 100048410;100080174 | CEP 2025-131 - Rev 01 | 2026/02/19 | Valid | 22/10/2030 | Chemical | 2026/02/19 | Minor revision|CEP granted|19/02/2026; New application|CEP granted|22/10/2025 |
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