| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2258 | Olanzapine | TORRENT PHARMACEUTICALS LIMITED Ahmedabad IN | 100004452;100001862 | CEP 2013-177 - Rev 05 | 2026/03/20 | Valid | Chemical | 2026/03/20 | Minor revision|CEP granted|20/03/2026; Notification|CEP granted|11/01/2024; Notification|CEP granted|02/11/2023; Minor revision|CEP granted|06/10/2023; Minor revision|Accepted - CEP remains valid|01/03/2021 |
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| 1519 | Flurbiprofen, Process II | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2021-039 - Rev 02 | 2026/03/20 | Valid | Chemical | 2026/03/20 | Renewal|CEP granted|20/03/2026; Monograph revision|CEP granted|10/01/2023; New application|CEP granted|15/04/2021 |
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| 883 | Calcitriol | CARBOGEN AMCIS B.V. Veenendaal NL | 100002010;100009870 | CEP 1996-009 - Rev 14 | 2026/03/20 | Valid | Chemical and TSE | 2026/03/20 | Minor revision|CEP granted|20/03/2026; Notification|Rejected|05/02/2026; Monograph revision|CEP granted|13/12/2024; Notification|CEP granted|03/03/2020 |
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| 1794 | Paclitaxel, Produced by a semi-synthetic process, product code SPT 1308 | SCINOPHARM TAIWAN LTD. Tainan TW | 100012108;100019515 | CEP 2015-278 - Rev 02 | 2026/03/20 | Valid | Chemical | 2026/03/20 | Minor revision|CEP granted|20/03/2026; Notification|CEP granted|11/09/2024; Renewal|CEP granted|10/06/2022; Minor revision|CEP granted|25/06/2020 |
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| 2775 | Nebivolol hydrochloride, Non-micronised, micronised | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2022-140 - Rev 02 | 2026/03/19 | Valid | 22/06/2028 | Chemical | 2026/03/19 | Minor revision|CEP granted|19/03/2026; Minor revision|CEP granted|20/12/2023; New application|CEP granted|22/06/2023 |
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| 2366 | Galantamine hydrobromide, Isolated from natural sources | GALEN-N EOOD Sofia BG | 100049230;100083398 | CEP 2024-450 - Rev 00 | 2026/03/19 | Valid | 19/03/2031 | Chemical | 2026/03/19 | New application|CEP granted|19/03/2026 | |
| 760 | Cytarabine | SAKAR HEALTHCARE LIMITED Ahmedabad IN | 100033943;100085048 | CEP 2025-029 - Rev 00 | 2026/03/19 | Valid | 19/03/2031 | Chemical | 2026/03/19 | New application|CEP granted|19/03/2026 | |
| 565 | Sodium nitroprusside | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2024-206 - Rev 00 | 2026/03/19 | Valid | 19/03/2031 | Chemical | 2026/03/19 | New application|CEP granted|19/03/2026 | |
| 2173 | Gabapentin, Site Yongtai Chiral | ZHEJIANG YONGTAI CHIRAL MEDICINE TECHNOLOGY CO. LTD. Taizhou CN | 100041319;100068021 | CEP 2022-303 - Rev 01 | 2026/03/19 | Valid | 27/10/2027 | Chemical | 2026/03/19 | Minor revision|CEP granted|19/03/2026; Minor revision|Accepted - CEP remains valid|16/09/2024; New application|CEP granted|27/10/2022 |
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| 2591 | Celecoxib, Micronised and non-micronised | KEKULE PHARMA LIMITED Hyderabad IN | 100033239;100051871 | CEP 2023-274 - Rev 01 | 2026/03/19 | Valid | 03/11/2030 | Chemical | 2026/03/19 | Minor revision|CEP granted|19/03/2026; New application|CEP granted|03/11/2025 |
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| 827 | Gonadorelin acetate | PIRAMAL PHARMA LIMITED Navi Mumbai IN | 100036948;100075608 | CEP 2025-161 - Rev 00 | 2026/03/19 | Valid | 19/03/2031 | Chemical | 2026/03/19 | New application|CEP granted|19/03/2026 | |
| 353 | Prednisolone | TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. Tianjin CN | 100011805;100018616 | CEP 2002-108 - Rev 05 | 2026/03/19 | Valid | Chemical | 2026/03/19 | Minor revision|CEP granted|19/03/2026; Major revision|Rejected|10/06/2020 |
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| 740 | Sulfadoxine | ANUH PHARMA LIMITED Mumbai IN | 100021566;100030259 | CEP 2022-457 - Rev 01 | 2026/03/19 | Valid | 23/02/2029 | Chemical | 2026/03/19 | Minor revision|CEP granted|19/03/2026; Notification|Accepted - CEP remains valid|06/11/2024; New application|CEP granted|23/02/2024 |
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| 2258 | Olanzapine, Form-I | LEE PHARMA LIMITED Hyderabad IN | 100014849;100042625 | CEP 2017-020 - Rev 01 | 2026/03/19 | Valid | Chemical | 2026/03/19 | Minor revision|CEP granted|19/03/2026; Minor revision|Rejected|24/10/2025; Renewal|CEP granted|22/05/2023; Major revision|CEP granted|15/03/2023 |
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| 2223 | Glimepiride | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2007-156 - Rev 05 | 2026/03/19 | Valid | Chemical | 2026/03/19 | Minor revision|CEP granted|19/03/2026; Notification|Accepted - CEP remains valid|25/10/2024; Notification|Accepted - CEP remains valid|15/12/2023; Minor revision|Accepted - CEP remains valid|23/11/2021 |
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| 454 | Acetazolamide | EMCURE PHARMACEUTICALS LIMITED Pune IN | 100011677;100099996 | CEP 2018-203 - Rev 03 | 2026/03/19 | Valid | Chemical | 2026/03/19 | Minor revision|CEP granted|19/03/2026; Renewal|CEP granted|26/02/2025; Minor revision|CEP granted|27/11/2023; Minor revision|Accepted - CEP remains valid|13/01/2022 |
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| 931 | Metformin Hydrochloride, 2nd line | NINGXIA HENGKANG TECHNOLOGY CO., LTD. Yinchuan CN | 100049743;100086705 | CEP 2024-237 - Rev 03 | 2026/03/19 | Valid | 02/08/2029 | Chemical | 2026/03/19 | Major revision|CEP granted|19/03/2026; Major revision|CEP granted|14/08/2025; Minor revision|CEP granted|23/12/2024; New application|CEP granted|02/08/2024 |
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| 335 | Hydrocortisone | HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN | 100016183;100024971 | CEP 2022-264 - Rev 01 | 2026/03/19 | Valid | 22/08/2028 | Chemical | 2026/03/19 | Minor revision|CEP granted|19/03/2026; New application|CEP granted|22/08/2023 |
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| 2254 | Moxifloxacin hydrochloride | HEC PHARM GMBH Berlin DE | 100002583;100098718 | CEP 2013-225 - Rev 04 | 2026/03/19 | Valid | Chemical | 2026/03/19 | Notification|CEP granted|19/03/2026; Administrative procedure|CEP granted|03/12/2024; Minor revision|CEP granted|05/08/2024; Minor revision|CEP granted|26/08/2021 |
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| . | Collagen | GUANGZHOU TRAUER BIOTECHNOLOGY CO., LTD. Guangzhou CN | 100055483;100098662 | CEP 2025-482 - Rev 00 | 2026/03/17 | Valid | 17/03/2031 | TSE | 2026/03/19 | New application|CEP granted|19/03/2026 |
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