| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 19 | Quinine sulfate | PT. SINKONA INDONESIA LESTARI Subang ID | 100015420;100024139 | CEP 2024-412 - Rev 00 | 2025/04/07 | Valid | 07/04/2030 | Chemical | 2025/04/07 | New application|CEP granted|07/04/2025 | |
| 227 | Lidocaine hydrochloride monohydrate | CHEMINO PHARMA LIMITED Mumbai IN | 100049314;100083804 | CEP 2021-084 - Rev 01 | 2025/04/07 | Valid | 14/08/2029 | Chemical | 2025/04/07 | Minor revision|CEP granted|07/04/2025; New application|CEP granted|14/08/2024 |
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| 2857 | Trazodone hydrochloride, Milled, Unmilled | INTAS PHARMACEUTICALS LIMITED Ahmedabad IN | 100011529;100023432 | CEP 2024-228 - Rev 00 | 2025/04/07 | Valid | 07/04/2030 | Chemical | 2025/04/07 | New application|CEP granted|07/04/2025 | |
| 2856 | Pirfenidone | AMOLI ORGANICS PRIVATE LIMITED Mumbai IN | 100016500;100025303 | CEP 2019-067 - Rev 02 | 2025/04/07 | Valid | Chemical | 2025/04/07 | Renewal|CEP granted|07/04/2025; Minor revision|CEP granted|11/09/2024; Minor revision|Accepted - CEP remains valid|22/05/2023; Notification|Rejected|20/03/2023 |
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| 1104 | Fluoxetine hydrochloride | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100029297 | CEP 2023-372 - Rev 00 | 2025/04/07 | Valid | 07/04/2030 | Chemical | 2025/04/07 | New application|CEP granted|07/04/2025 | |
| 2287 | Fluconazole, Process II | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2009-226 - Rev 04 | 2025/04/04 | Valid | Chemical | 2025/04/04 | Notification|CEP granted|04/04/2025; Minor revision|CEP granted|09/01/2025; Notification|CEP granted|06/12/2022 |
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| 2631 | Rosuvastatin calcium | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2016-175 - Rev 01 | 2025/04/04 | Valid | Chemical | 2025/04/04 | Notification|CEP granted|04/04/2025; Renewal|CEP granted|26/04/2023; Notification|CEP granted|06/12/2022; Major revision|CEP granted|24/06/2022; Major revision|Rejected|27/08/2021; Monograph revision|Accepted - CEP remains valid|24/08/2020 |
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| 2631 | Rosuvastatin calcium, D518 Process | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2021-265 - Rev 02 | 2025/04/04 | Valid | 05/01/2027 | Chemical | 2025/04/04 | Notification|CEP granted|04/04/2025; Notification|CEP granted|05/12/2022; New application|CEP granted|05/01/2022 |
|
| 2585 | Rizatriptan benzoate | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2012-108 - Rev 03 | 2025/04/04 | Valid | Chemical | 2025/04/04 | Notification|CEP granted|04/04/2025; Notification|CEP granted|05/12/2022; Minor revision|CEP granted|07/01/2022 |
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| 2856 | Pirfenidone | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2017-170 - Rev 04 | 2025/04/04 | Valid | Chemical | 2025/04/04 | Notification|CEP granted|04/04/2025; Renewal|CEP granted|15/04/2024; Notification|CEP granted|05/12/2022 |
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| 2019 | Perindopril tert-butylamine | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2004-279 - Rev 06 | 2025/04/04 | Valid | Chemical | 2025/04/04 | Notification|CEP granted|04/04/2025; Notification|CEP granted|05/12/2022; Monograph revision|Accepted - CEP remains valid|09/04/2020 |
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| 228 | Lithium carbonate | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2023-190 - Rev 01 | 2025/04/04 | Valid | 11/01/2029 | Chemical | 2025/11/04 | Notification|Accepted - CEP remains valid|04/11/2025; Notification|CEP granted|04/04/2025; New application|CEP granted|11/01/2024 |
|
| 2992 | Lacosamide | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2021-163 - Rev 02 | 2025/04/04 | Valid | 14/09/2027 | Chemical | 2025/04/04 | Notification|CEP granted|04/04/2025; Notification|CEP granted|14/12/2022; New application|CEP granted|14/09/2022 |
|
| 2223 | Glimepiride, Process-II | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2022-481 - Rev 01 | 2025/04/04 | Valid | 22/09/2028 | Chemical | 2025/04/04 | Notification|CEP granted|04/04/2025; New application|CEP granted|22/09/2023 |
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| 2223 | Glimepiride | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2006-172 - Rev 04 | 2025/04/04 | Valid | Chemical | 2025/04/04 | Notification|CEP granted|04/04/2025; Minor revision|CEP granted|28/11/2022 |
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| 2736 | Imatinib mesilate, β form, milled, non-milled | SHANDONG ANXIN PHARMACEUTICAL CO., LTD Jinan CN | 100012114;100052387 | CEP 2017-292 - Rev 04 | 2025/04/04 | Valid | Chemical | 2025/04/04 | Minor revision|CEP granted|04/04/2025; Major revision|Accepted - CEP remains valid|26/09/2024; Renewal|CEP granted|28/06/2024; Minor revision|CEP granted|27/06/2022 |
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| 2287 | Fluconazole | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2007-100 - Rev 03 | 2025/04/04 | Valid | Chemical | 2025/04/04 | Notification|CEP granted|04/04/2025; Notification|CEP granted|05/12/2022 |
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| 1590 | Epirubicin hydrochloride | SYNBIAS PHARMA AG Schaffhausen CH | 100049474;100084538 | CEP 2023-380 - Rev 00 | 2025/04/03 | Valid | 03/04/2030 | Chemical | 2025/04/03 | New application|CEP granted|03/04/2025 | |
| 2988 | Fingolimod hydrochloride | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2020-108 - Rev 01 | 2025/04/03 | Valid | 30/06/2027 | Chemical | 2025/04/03 | Notification|CEP granted|03/04/2025; Monograph revision|Accepted - CEP remains valid|19/04/2024; New application|CEP granted|30/06/2022 |
|
| 1058 | Vancomycin hydrochloride | XELLIA PHARMACEUTICALS APS Copenhagen S DK | 100004144;100002734 | CEP 2007-195 - Rev 03 | 2025/04/03 | Valid | Chemical | 2025/04/03 | Minor revision|CEP granted|03/04/2025; Minor revision|Accepted - CEP remains valid|14/03/2024; Notification|Accepted - CEP remains valid|09/02/2023; Minor revision|Accepted - CEP remains valid|16/02/2022; Notification|Accepted - CEP remains valid|15/12/2020 |
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