| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2778 | Sitagliptin phosphate monohydrate, Process-II | AMOLI ORGANICS PRIVATE LIMITED Mumbai IN | 100016500;100025303 | CEP 2025-485 - Rev 00 | 2026/03/30 | Valid | 30/03/2031 | Chemical | 2026/03/30 | New application|CEP granted|30/03/2026 | |
| 2849 | Hydroxychloroquine sulfate | EUROAPI HUNGARY KFT. Budapest IV HU | 100039256;100061798 | CEP 2024-540 - Rev 00 | 2026/03/30 | Valid | 30/03/2031 | Chemical | 2026/03/30 | New application|CEP granted|30/03/2026 | |
| 1442 | Leuprorelin | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2014-278 - Rev 02 | 2026/03/30 | Valid | Chemical | 2026/03/30 | Notification|CEP granted|30/03/2026; Minor revision|CEP granted|19/12/2024; Renewal|CEP granted|26/02/2021 |
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| 1314 | Dosulepin hydrochloride | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2003-157 - Rev 07 | 2026/03/30 | Valid | Chemical | 2026/03/30 | Notification|CEP granted|30/03/2026; Minor revision|CEP granted|25/07/2025; Minor revision|CEP granted|10/08/2023 |
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| 2762 | Capecitabine | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2016-140 - Rev 01 | 2026/03/30 | Valid | Chemical | 2026/03/30 | Notification|CEP granted|30/03/2026; Renewal|CEP granted|08/09/2022 |
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| 1002 | Diclofenac sodium | YUNG ZIP CHEMICAL IND. CO., LTD. Taichung TW | 100023062;100031811 | CEP 2018-016 - Rev 04 | 2026/03/30 | Valid | Chemical | 2026/03/30 | Minor revision|CEP granted|30/03/2026; Renewal|CEP granted|20/12/2024; Minor revision|CEP granted|16/08/2022; Minor revision|CEP granted|23/09/2021 |
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| 2306 | Gemcitabine hydrochloride | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2007-021 - Rev 03 | 2026/03/30 | Valid | Chemical | 2026/03/30 | Notification|CEP granted|30/03/2026; Minor revision|CEP granted|12/06/2024 |
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| 2373 | Meloxicam | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2009-184 - Rev 02 | 2026/03/30 | Valid | Chemical | 2026/03/30 | Notification|CEP granted|30/03/2026; Minor revision|CEP granted|01/03/2024 |
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| 1448 | Metoprolol succinate | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2004-197 - Rev 06 | 2026/03/30 | Valid | Chemical | 2026/03/30 | Notification|CEP granted|30/03/2026; Minor revision|CEP granted|19/07/2024; Minor revision|CEP granted|22/08/2023; Minor revision|Accepted - CEP remains valid|17/03/2021 |
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| 678 | Sodium valproate | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2004-027 - Rev 05 | 2026/03/30 | Valid | Chemical | 2026/03/30 | Notification|CEP granted|30/03/2026; Minor revision|CEP granted|16/12/2020 |
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| 599 | Cisplatin | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2004-305 - Rev 04 | 2026/03/27 | Valid | Chemical | 2026/03/27 | Notification|CEP granted|27/03/2026; Minor revision|CEP granted|14/01/2025 |
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| 2334 | Letrozole | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2009-147 - Rev 02 | 2026/03/27 | Valid | Chemical | 2026/03/27 | Notification|CEP granted|27/03/2026; Notification|Accepted - CEP remains valid|26/06/2023; Minor revision|Accepted - CEP remains valid|03/10/2022; Minor revision|CEP granted|08/03/2022; Monograph revision|Accepted - CEP remains valid|05/03/2021 |
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| 2017 | Oxaliplatin | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2007-044 - Rev 03 | 2026/03/27 | Valid | Chemical | 2026/03/27 | Notification|CEP granted|27/03/2026; Minor revision|Rejected|02/07/2024; Minor revision|Accepted - CEP remains valid|27/10/2022; Minor revision|Accepted - CEP remains valid|17/05/2022; Notification|Rejected|22/03/2022 |
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| 2119 | Venlafaxine hydrochloride | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2007-151 - Rev 03 | 2026/03/27 | Valid | Chemical | 2026/03/27 | Notification|CEP granted|27/03/2026; Notification|Accepted - CEP remains valid|22/08/2024; Notification|Accepted - CEP remains valid|07/08/2023; Minor revision|Accepted - CEP remains valid|11/03/2022 |
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| 1699 | Mesalazine | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2003-267 - Rev 07 | 2026/03/27 | Valid | Chemical | 2026/03/27 | Notification|CEP granted|27/03/2026; Minor revision|CEP granted|20/02/2023 |
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| 2296 | Pantoprazole sodium sesquihydrate | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2009-122 - Rev 03 | 2026/03/27 | Valid | Chemical | 2026/03/27 | Notification|CEP granted|27/03/2026; Minor revision|Accepted - CEP remains valid|10/02/2023 |
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| 1681 | Tramadol hydrochloride | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2002-232 - Rev 08 | 2026/03/27 | Valid | Chemical | 2026/03/27 | Notification|CEP granted|27/03/2026; Minor revision|CEP granted|12/06/2024; Minor revision|Accepted - CEP remains valid|20/10/2022 |
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| 2888 | Rupatadine fumarate | TYCHE INDUSTRIES LIMITED Hyderabad IN | 100019502;100090730 | CEP 2018-213 - Rev 02 | 2026/03/27 | Valid | Chemical | 2026/03/27 | Renewal|CEP granted|27/03/2026; Major revision|Accepted - CEP remains valid|28/08/2023; Major revision|CEP granted|26/10/2022 |
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| 2133 | Troxerutin | CHENGDU OKAY PHARMACEUTICAL CO. LTD. Qionglai CN | 100024058;100033233 | CEP 2024-296 - Rev 00 | 2026/03/27 | Valid | 27/03/2031 | Chemical | 2026/03/27 | New application|CEP granted|27/03/2026 | |
| 2541 | Quetiapine Fumarate | VASUDHA PHARMA CHEM LIMITED Hyderabad IN | 100011811;100018603 | CEP 2019-035 - Rev 03 | 2026/03/27 | Valid | Chemical | 2026/03/27 | Renewal|CEP granted|27/03/2026; Minor revision|CEP granted|29/11/2023; Notification|CEP granted|31/01/2023 |
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