| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 797 | Aspartic Acid | SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN | 100025187;100034386 | CEP 2007-353 - Rev 02 | 2025/10/02 | Valid | Chemical | 2025/10/02 | Notification|CEP granted|02/10/2025; Notification|CEP granted|15/05/2024; Minor revision|Accepted - CEP remains valid|09/05/2023 |
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| 1335 | Itraconazole, II | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100029297 | CEP 2025-246 - Rev 00 | 2025/10/02 | Valid | 02/10/2030 | Chemical | 2025/10/02 | New application|CEP granted|02/10/2025 | |
| 805 | Arginine hydrochloride | SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN | 100025187;100034386 | CEP 2010-048 - Rev 01 | 2025/10/01 | Valid | Chemical | 2025/10/01 | Notification|CEP granted|01/10/2025; Minor revision|Accepted - CEP remains valid|07/06/2024; Minor revision|Accepted - CEP remains valid|15/05/2023 |
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| 911 | Histidine | SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN | 100025187;100034386 | CEP 2010-046 - Rev 02 | 2025/10/01 | Valid | Chemical | 2025/10/01 | Notification|CEP granted|01/10/2025; Minor revision|Accepted - CEP remains valid|07/06/2024; Notification|Accepted - CEP remains valid|09/02/2022; Minor revision|Accepted - CEP remains valid|16/12/2021 |
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| 782 | Phenylalanine | SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN | 100025187;100034386 | CEP 2010-225 - Rev 04 | 2025/10/01 | Valid | Chemical | 2025/10/01 | Notification|CEP granted|01/10/2025; Minor revision|CEP granted|14/06/2024; Notification|Accepted - CEP remains valid|04/02/2022; Minor revision|CEP granted|29/11/2021 |
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| 1756 | Lamotrigine, Micronised and non-micronised | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2010-208 - Rev 03 | 2025/10/01 | Valid | Chemical | 2025/10/01 | Minor revision|CEP granted|01/10/2025; Major revision|CEP granted|02/12/2024; Major revision|CEP granted|02/02/2023; Notification|Accepted - CEP remains valid|18/02/2020 |
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| 806 | Arginine | SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN | 100025187;100034386 | CEP 2010-045 - Rev 01 | 2025/10/01 | Valid | Chemical | 2025/10/01 | Notification|CEP granted|01/10/2025; Minor revision|Accepted - CEP remains valid|07/06/2024; Minor revision|Accepted - CEP remains valid|09/12/2022; Notification|Accepted - CEP remains valid|31/08/2020 |
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| 788 | Serine | SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN | 100025187;100034386 | CEP 2008-003 - Rev 01 | 2025/10/01 | Valid | Chemical | 2025/10/01 | Notification|CEP granted|01/10/2025; Notification|Accepted - CEP remains valid|07/05/2024; Minor revision|Accepted - CEP remains valid|11/08/2023; Minor revision|Accepted - CEP remains valid|31/08/2022 |
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| 2631 | Rosuvastatin calcium, 000757, milled | KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI | 100000627;100009540 | CEP 2025-290 - Rev 00 | 2025/10/01 | Valid | 01/10/2030 | Chemical | 2025/12/12 | Minor revision|Accepted - CEP remains valid|12/12/2025; New application|CEP granted|01/10/2025 |
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| 2531 | Clopidogrel hydrogen sulfate, Process 2 | SYNTHIMED LABS PRIVATE LIMITED Derabassi IN | 100052287;100092080 | CEP 2025-346 - Rev 00 | 2025/10/01 | Valid | 01/10/2030 | Chemical | 2025/10/01 | New application|CEP granted|01/10/2025 | |
| 2866 | Gefitinib, Micronised and Non-micronised | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | 100011732;100023530 | CEP 2016-227 - Rev 03 | 2025/10/01 | Valid | Chemical | 2025/10/01 | Minor revision|CEP granted|01/10/2025; Renewal|CEP granted|23/01/2024; Minor revision|CEP granted|25/11/2020 |
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| 549 | Dexamethasone sodium phosphate | SHANDONG SIRUI PHARMACEUTICAL CO., LTD. Heze CN | 100049295;100083729 | CEP 2025-180 - Rev 00 | 2025/10/01 | Valid | 01/10/2030 | Chemical | 2025/10/01 | New application|CEP granted|01/10/2025 | |
| 1448 | Metoprolol succinate | GRANULES INDIA LIMITED Hyderabad IN | 100011671;100097387 | CEP 2019-232 - Rev 04 | 2025/10/01 | Valid | Chemical | 2025/10/01 | Renewal|CEP granted|01/10/2025; Major revision|CEP granted|04/03/2025; Notification|CEP granted|10/06/2024; Minor revision|CEP granted|03/05/2023 |
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| 2583 | Montelukast sodium, Process-II | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2024-151 - Rev 01 | 2025/10/01 | Valid | 31/07/2029 | Chemical | 2025/10/01 | Notification|CEP granted|01/10/2025; Monograph revision|Accepted - CEP remains valid|26/03/2025; New application|CEP granted|31/07/2024 |
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| 1199 | Dipyridamole | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2011-244 - Rev 05 | 2025/09/30 | Valid | Chemical | 2025/09/30 | Notification|CEP granted|30/09/2025; Notification|CEP granted|30/07/2024; Major revision|CEP granted|31/03/2022 |
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| 408 | Methadone hydrochloride | PIONEER AGRO INDUSTRIES SANVIN LABORATORIES PRIVATE LIMITED Mumbai IN | 100014944;100038683 | CEP 2003-062 - Rev 02 | 2025/09/30 | Valid | Chemical | 2025/09/30 | Minor revision|CEP granted|30/09/2025; Notification|CEP granted|03/10/2023 |
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| 1059 | Zidovudine | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2007-318 - Rev 07 | 2025/09/30 | Valid | Chemical | 2025/09/30 | Notification|CEP granted|30/09/2025; Notification|CEP granted|18/07/2024; Minor revision|CEP granted|03/05/2023; Monograph revision|Accepted - CEP remains valid|07/01/2022; Minor revision|CEP granted|27/05/2020 |
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| 1049 | Threonine | SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN | 100025187;100034386 | CEP 2010-044 - Rev 01 | 2025/09/30 | Valid | Chemical | 2025/09/30 | Notification|CEP granted|30/09/2025; Notification|Accepted - CEP remains valid|07/05/2024; Minor revision|Accepted - CEP remains valid|08/08/2023; Minor revision|Accepted - CEP remains valid|20/03/2023 |
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| 1705 | Sertraline hydrochloride | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2008-304 - Rev 05 | 2025/09/30 | Valid | Chemical | 2025/09/30 | Notification|CEP granted|30/09/2025; Notification|CEP granted|18/07/2024; Minor revision|CEP granted|24/04/2023; Major revision|Rejected|23/03/2023 |
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| 2136 | Ritonavir, Form-II | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2011-221 - Rev 03 | 2025/09/30 | Valid | Chemical | 2025/09/30 | Notification|CEP granted|30/09/2025; Notification|CEP granted|25/07/2024; Minor revision|Accepted - CEP remains valid|20/09/2023; Minor revision|CEP granted|06/09/2021 |
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