| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1681 | Tramadol hydrochloride | EMNAR PHARMA PRIVATE LIMITED Hyderabad IN | 100033980;100065255 | CEP 2013-320 - Rev 03 | 2026/02/25 | Valid | Chemical | 2026/02/25 | Minor revision|CEP granted|25/02/2026; Notification|CEP granted|27/10/2023; Major revision|CEP granted|03/02/2022; Minor revision|Rejected|19/07/2021; Renewal|CEP granted|10/08/2020 |
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| 928 | Lomustine | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2009-141 - Rev 04 | 2026/02/23 | Valid | Chemical | 2026/02/23 | Minor revision|CEP granted|23/02/2026; Notification|Rejected|12/01/2026; Minor revision|CEP granted|16/08/2024; Minor revision|Accepted - CEP remains valid|25/02/2021 |
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| 464 | Amitriptyline hydrochloride | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2001-432 - Rev 07 | 2026/02/23 | Valid | Chemical | 2026/02/23 | Major revision|CEP granted|23/02/2026; Notification|CEP granted|11/03/2025; Minor revision|CEP granted|07/05/2024; Notification|Accepted - CEP remains valid|05/07/2023; Notification|Accepted - CEP remains valid|02/08/2022; Notification|CEP granted|04/02/2022; Minor revision|Accepted - CEP remains valid|12/10/2021; Notification|Rejected|16/08/2021 |
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| 417 | Oxygen | LINDE GMBH Pullach I. Isartal DE | 100017889;100043514 | CEP 2019-005 - Rev 06 | 2026/02/23 | Valid | Chemical | 2026/02/23 | Notification|CEP granted|23/02/2026; Renewal|Accepted - CEP remains valid|31/01/2025; Notification|CEP granted|05/06/2024; Minor revision|CEP granted|09/02/2024; Notification|Accepted - CEP remains valid|12/12/2022; Minor revision|CEP granted|11/04/2022; Notification|CEP granted|21/01/2021; Notification|CEP granted|30/10/2020 |
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| 2131 | Tamsulosin hydrochloride | COHANCE LIFESCIENCES LIMITED Mumbai IN | 100011755;100090273 | CEP 2007-014 - Rev 06 | 2026/02/23 | Valid | Chemical | 2026/02/23 | Notification|CEP granted|23/02/2026; Notification|CEP granted|15/05/2020 |
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| 809 | Betamethasone dipropionate, Micronised | TARO PHARMACEUTICAL INDUSTRIES, LTD. Haifa IL | 100004559;100001120 | CEP 2018-018 - Rev 04 | 2026/02/23 | Valid | Chemical | 2026/02/18 | Minor revision|CEP granted|18/02/2026; Minor revision|CEP granted|19/05/2025; Renewal|CEP granted|19/03/2024 |
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| 2760 | Brimonidine tartrate | FDC Limited Mumbai IN | 100011646;100021030 | CEP 2020-123 - Rev 01 | 2026/02/23 | Valid | 13/06/2027 | Chemical | 2026/02/23 | Minor revision|CEP granted|23/02/2026; New application|CEP granted|13/06/2022 |
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| 417 | Oxygen | SOL S.P.A. Monza IT | 100002061;100001723 | CEP 2020-295 - Rev 01 | 2026/02/23 | Valid | Chemical | 2026/02/23 | Renewal|CEP granted|23/02/2026; New application|CEP granted|10/05/2021 |
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| 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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| 3139 | Brivaracetam | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2024-088 - Rev 01 | 2026/02/23 | Valid | 02/06/2030 | Chemical | 2026/02/23 | Major revision|CEP granted|23/02/2026; New application|CEP granted|02/06/2025 |
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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 |
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| 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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