| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1280 | Zolpidem tartrate | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2006-293 - Rev 08 | 2025/09/16 | Valid | Chemical | 2025/09/16 | Notification|CEP granted|16/09/2025; Notification|CEP granted|22/07/2024; Notification|CEP granted|31/08/2021; Monograph revision|CEP granted|01/10/2020 |
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| 2283 | Paroxetine hydrochloride | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2009-155 - Rev 05 | 2025/09/16 | Valid | Chemical | 2025/09/16 | Notification|CEP granted|16/09/2025; Notification|CEP granted|19/07/2024; Notification|CEP granted|31/08/2021 |
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| 2018 | Paroxetine hydrochloride hemihydrate | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2009-154 - Rev 04 | 2025/09/16 | Valid | Chemical | 2025/09/16 | Notification|CEP granted|16/09/2025; Notification|CEP granted|19/07/2024; Notification|CEP granted|31/08/2021 |
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| 937 | Minoxidil | TRIFARMA S.P.A. Ceriano Laghetto IT | 100013844;100019766 | CEP 2024-331 - Rev 00 | 2025/09/16 | Valid | 16/09/2030 | Chemical | 2025/09/16 | New application|CEP granted|16/09/2025 | |
| 2192 | Atovaquone | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2013-194 - Rev 04 | 2025/09/16 | Valid | Chemical | 2025/09/16 | Notification|CEP granted|16/09/2025; Notification|CEP granted|22/07/2024; Notification|CEP granted|31/08/2021 |
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| 147 | Naphazoline nitrate | FARMAK JSC Kyiv UA | 100004891;100006050 | CEP 2025-137 - Rev 00 | 2025/09/16 | Valid | 16/09/2030 | Chemical | 2025/09/16 | New application|CEP granted|16/09/2025 | |
| 2531 | Clopidogrel hydrogen sulfate, Process II | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2019-142 - Rev 02 | 2025/09/16 | Withdrawn by Holder | 2026/04/17 | Chemical | 2025/09/16 | ||
| 2296 | Pantoprazole sodium sesquihydrate | Ulkar Kimya Sanayii Ve Ticaret Anonim Sirketi Istanbul TR | 100022492;100082995 | CEP 2024-048 - Rev 00 | 2025/09/15 | Valid | 15/09/2030 | Chemical | 2025/09/15 | New application|CEP granted|15/09/2025 | |
| 1425 | Fosfomycin trometamol | CLAROCHEM IRELAND LTD. Dublin 15 IE | 100016003;100024745 | CEP 2022-327 - Rev 01 | 2025/09/15 | Valid | 17/05/2028 | Chemical | 2025/09/15 | Minor revision|CEP granted|15/09/2025; New application|CEP granted|17/05/2023 |
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| 811 | Betamethasone valerate | AURISCO PHARMACEUTICAL CO., LTD. Tiantai CN | 100011968;100018590 | CEP 2021-120 - Rev 02 | 2025/09/15 | Valid | 31/05/2027 | Chemical | 2025/09/15 | Minor revision|CEP granted|15/09/2025; Minor revision|CEP granted|14/09/2022; New application|CEP granted|31/05/2022 |
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| 2531 | Clopidogrel hydrogen sulfate, Form II, AS | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2025-295 - Rev 01 | 2025/09/15 | Withdrawn by Holder | 2026/05/07 | Chemical | 2025/09/15 | ||
| 1029 | Mexiletine hydrochloride | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2021-421 - Rev 01 | 2025/09/15 | Valid | 10/03/2028 | Chemical | 2025/09/15 | Minor revision|CEP granted|15/09/2025; Minor revision|Accepted - CEP remains valid|05/09/2024; New application|CEP granted|10/03/2023 |
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| 1711 | Buspirone hydrochloride | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2024-108 - Rev 00 | 2025/09/15 | Valid | 15/09/2030 | Chemical | 2025/09/15 | New application|CEP granted|15/09/2025 | |
| 1649 | Azithromycin, Dihydrate | SHANDONG ANXIN PHARMACEUTICAL CO., LTD Jinan CN | 100012114;100052387 | CEP 2025-033 - Rev 00 | 2025/09/15 | Valid | 15/09/2030 | Chemical | 2025/09/15 | New application|CEP granted|15/09/2025 | |
| 2255 | Nevirapine | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2011-075 - Rev 06 | 2025/09/15 | Valid | Chemical | 2025/09/15 | Notification|CEP granted|15/09/2025; Notification|CEP granted|18/07/2024; Minor revision|CEP granted|19/12/2023; Notification|CEP granted|31/08/2021 |
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| 2615 | Lopinavir | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2013-011 - Rev 04 | 2025/09/15 | Valid | Chemical | 2025/09/15 | Notification|CEP granted|15/09/2025; Notification|CEP granted|23/07/2024; Major revision|CEP granted|31/01/2024; Minor revision|CEP granted|30/08/2021 |
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| 2254 | Moxifloxacin hydrochloride | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2013-201 - Rev 04 | 2025/09/15 | Valid | Chemical | 2025/09/15 | Notification|CEP granted|15/09/2025; Minor revision|CEP granted|19/07/2024; Minor revision|CEP granted|25/10/2023; Notification|CEP granted|31/08/2021; Renewal|CEP granted|02/09/2020 |
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| 2640 | Atomoxetine hydrochloride | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2013-271 - Rev 04 | 2025/09/15 | Valid | Chemical | 2025/09/15 | Notification|CEP granted|15/09/2025; Minor revision|CEP granted|05/02/2025; Notification|CEP granted|22/07/2024; Notification|CEP granted|31/08/2021 |
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| 737 | Hyoscine butylbromide | ALKALOIDS PRIVATE LIMITED Secunderabad IN | 100021602;100041426 | CEP 2002-158 - Rev 06 | 2025/09/12 | Valid | Chemical | 2025/09/12 | Minor revision|CEP granted|12/09/2025; Transfer of holdership|CEP granted|11/12/2023; Notification|CEP granted|19/02/2021 |
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| 1702 | Naproxen sodium | ZHEJIANG CHARIOTEER PHARMACEUTICAL CO., LTD Xianju CN | 100011826;100018693 | CEP 2010-021 - Rev 03 | 2025/09/12 | Valid | Chemical | 2025/09/12 | Administrative procedure|CEP granted|12/09/2025; Minor revision|CEP granted|04/09/2025; Notification|Accepted - CEP remains valid|10/11/2023; Notification|Accepted - CEP remains valid|05/01/2022 |
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