| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 3095 | Dabigatran etexilate mesilate, Form-I | BIOCON LIMITED Pashamylaram IN | 100011487;100021549 | CEP 2024-046 - Rev 00 | 2025/10/09 | Valid | 09/10/2030 | Chemical | 2025/10/09 | New application|CEP granted|09/10/2025 | |
| 653 | Baclofen | VIYASH LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100040217;100065484 | CEP 2024-145 - Rev 00 | 2025/10/09 | Valid | 09/10/2030 | Chemical | 2025/10/09 | New application|CEP granted|09/10/2025 | |
| 771 | Leucine | SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN | 100025187;100034386 | CEP 2010-189 - Rev 01 | 2025/10/08 | Valid | Chemical | 2025/10/08 | Notification|CEP granted|08/10/2025; Minor revision|Accepted - CEP remains valid|18/11/2024; Minor revision|Accepted - CEP remains valid|18/06/2024; Minor revision|Accepted - CEP remains valid|22/11/2022 |
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| 369 | Azathioprine, Process 2 | AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN | 100045727;100075371 | CEP 2014-030 - Rev 02 | 2025/10/08 | Valid | Chemical | 2025/10/08 | Minor revision|CEP granted|08/10/2025; Minor revision|Accepted - CEP remains valid|29/01/2024; Notification|CEP granted|20/10/2022; Minor revision|Accepted - CEP remains valid|10/06/2022 |
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| 785 | Proline | SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN | 100025187;100034386 | CEP 2010-263 - Rev 02 | 2025/10/08 | Valid | Chemical | 2025/10/08 | Notification|CEP granted|08/10/2025; Notification|CEP granted|11/06/2024; Minor revision|Accepted - CEP remains valid|11/08/2023; Notification|Accepted - CEP remains valid|09/02/2022; Minor revision|Accepted - CEP remains valid|18/11/2021 |
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| 653 | Baclofen | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2006-229 - Rev 03 | 2025/10/08 | Valid | Chemical | 2025/10/08 | Notification|CEP granted|08/10/2025; Notification|CEP granted|26/07/2024 |
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| 2992 | Lacosamide | LEE PHARMA LIMITED Hyderabad IN | 100014849;100042625 | CEP 2019-223 - Rev 01 | 2025/10/08 | Valid | 21/10/2026 | Chemical | 2025/10/08 | Minor revision|CEP granted|08/10/2025 | |
| 926 | Levonorgestrel, Micronised, Process II | QINHUANGDAO ZIZHU PHARMACEUTICAL CO., LTD. Qinhuangdao City CN | 100016470;100025257 | CEP 2022-225 - Rev 02 | 2025/10/08 | Valid | 20/12/2027 | Chemical | 2025/10/08 | Administrative procedure|CEP granted|08/10/2025; Notification|CEP granted|23/09/2025; New application|CEP granted|20/12/2022 |
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| 711 | Cyclophosphamide monohydrate | SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN | 100044578;100073706 | CEP 2020-083 - Rev 03 | 2025/10/08 | Valid | 27/08/2026 | Chemical | 2025/10/08 | Minor revision|CEP granted|08/10/2025; Monograph revision|CEP granted|09/01/2023; Notification|CEP granted|21/07/2022; New application|CEP granted|27/08/2021 |
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| 20 | Dextromethorphan hydrobromide monohydrate | WANBURY LIMITED Vashi, Navi Mumbai IN | 100021364;100030068 | CEP 2022-268 - Rev 01 | 2025/10/08 | Valid | 03/09/2029 | Chemical | 2025/10/08 | Monograph revision|CEP granted|08/10/2025; New application|CEP granted|03/09/2024 |
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| 2191 | Atorvastatin calcium | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2011-184 - Rev 05 | 2025/10/07 | Valid | Chemical | 2025/10/07 | Notification|CEP granted|07/10/2025; Minor revision|CEP granted|27/09/2024; Notification|CEP granted|29/07/2024; Monograph revision|CEP granted|10/08/2022 |
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| 913 | Hydroxocobalamin acetate | EUROAPI FRANCE Paris FR | 100039327;100097848 | CEP 2001-179 - Rev 10 | 2025/10/07 | Valid | Chemical | 2025/10/07 | Notification|CEP granted|07/10/2025; Notification|Accepted - CEP remains valid|01/04/2025; Notification|CEP granted|01/08/2024; Notification|CEP granted|09/02/2024; Minor revision|CEP granted|28/07/2022; Minor revision|Accepted - CEP remains valid|04/03/2020 |
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| 2423 | Valsartan | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2009-396 - Rev 08 | 2025/10/07 | Valid | Chemical | 2025/10/07 | Notification|CEP granted|07/10/2025; Notification|CEP granted|26/07/2024; Minor revision|CEP granted|23/02/2022 |
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| 1564 | Sodium alendronate trihydrate | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2009-290 - Rev 03 | 2025/10/07 | Valid | Chemical | 2025/10/07 | Notification|CEP granted|07/10/2025; Notification|CEP granted|26/07/2024 |
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| 914 | Hydroxocobalamin chloride | EUROAPI FRANCE Paris FR | 100039327;100097848 | CEP 2001-437 - Rev 09 | 2025/10/07 | Valid | Chemical | 2025/10/07 | Notification|CEP granted|07/10/2025; Notification|Accepted - CEP remains valid|12/05/2025; Minor revision|CEP granted|05/07/2024; Notification|CEP granted|09/02/2024; Minor revision|CEP granted|22/08/2022; Notification|CEP granted|30/11/2021 |
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| 2423 | Valsartan, Process II | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2024-007 - Rev 02 | 2025/10/07 | Valid | 12/06/2029 | Chemical | 2025/10/07 | Notification|CEP granted|07/10/2025; Notification|CEP granted|26/07/2024; New application|CEP granted|12/06/2024 |
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| 1705 | Sertraline hydrochloride, Process-II | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2023-151 - Rev 04 | 2025/10/07 | Valid | 12/07/2028 | Chemical | 2025/10/07 | Notification|CEP granted|07/10/2025; Minor revision|CEP granted|08/07/2025; Administrative procedure|CEP granted|01/08/2024; Notification|CEP granted|25/07/2024; New application|CEP granted|12/07/2023 |
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| 2270 | Sildenafil citrate | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2012-317 - Rev 03 | 2025/10/07 | Valid | Chemical | 2025/10/07 | Notification|CEP granted|07/10/2025; Minor revision|CEP granted|05/03/2025; Notification|CEP granted|25/07/2024 |
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| 2857 | Trazodone hydrochloride | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2023-159 - Rev 01 | 2025/10/07 | Valid | 08/08/2029 | Chemical | 2025/10/07 | Notification|CEP granted|07/10/2025; Minor revision|Accepted - CEP remains valid|17/04/2025; New application|CEP granted|08/08/2024 |
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| 2423 | Valsartan, Process III | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2024-113 - Rev 02 | 2025/10/07 | Valid | 14/06/2029 | Chemical | 2025/10/07 | Notification|CEP granted|07/10/2025; Notification|CEP granted|25/07/2024; New application|CEP granted|14/06/2024 |
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