| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1104 | Fluoxetine hydrochloride | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2023-400 - Rev 00 | 2025/04/08 | Valid | 08/04/2030 | Chemical | 2025/04/08 | New application|CEP granted|08/04/2025 | |
| 2777 | Pregabalin | ENANTI LABS PRIVATE LIMITED Anakapalli District IN | 100047758;100078940 | CEP 2023-199 - Rev 00 | 2025/04/08 | Valid | 08/04/2030 | Chemical | 2025/04/08 | New application|CEP granted|08/04/2025 | |
| 2423 | Valsartan | CPL PHARMACEUTICALS PRIVATE LIMITED Ahmedabad IN | 100048075;100079517 | CEP 2023-282 - Rev 00 | 2025/04/08 | Valid | 08/04/2030 | Chemical | 2025/04/08 | New application|CEP granted|08/04/2025 | |
| 2196 | Bicalutamide, Form-H1 | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2012-254 - Rev 03 | 2025/04/07 | Valid | Chemical | 2025/04/07 | Minor revision|CEP granted|07/04/2025; Minor revision|Accepted - CEP remains valid|11/08/2023; Minor revision|CEP granted|09/01/2023; Minor revision|Accepted - CEP remains valid|16/03/2022; Notification|Rejected|17/01/2022; Minor revision|CEP granted|29/06/2020 |
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| 2787 | Esomeprazole magnesium dihydrate | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2014-258 - Rev 03 | 2025/04/07 | Valid | Chemical | 2025/04/07 | Notification|CEP granted|07/04/2025; Minor revision|Accepted - CEP remains valid|26/02/2024; Minor revision|CEP granted|09/02/2023; Notification|CEP granted|06/12/2022; Renewal|CEP granted|02/12/2020; Minor revision|CEP granted|24/06/2020 |
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| 2017 | Oxaliplatin, Process HER-1 | HERAEUS PRECIOUS METALS GMBH & CO. KG Hanau DE | 100012310;100021629 | CEP 2003-278 - Rev 09 | 2025/04/07 | Valid | Chemical | 2025/04/07 | Notification|CEP granted|07/04/2025; Notification|CEP granted|02/10/2023; Notification|CEP granted|07/07/2022; Notification|Accepted - CEP remains valid|03/06/2021; Minor revision|CEP granted|26/03/2021 |
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| 816 | Cinnarizine | FDC Limited Mumbai IN | 100011646;100021030 | CEP 2003-150 - Rev 04 | 2025/04/07 | Valid | Chemical | 2025/04/07 | Monograph revision|CEP granted|07/04/2025; Minor revision|CEP granted|08/09/2023; Minor revision|Accepted - CEP remains valid|21/07/2022 |
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| 2856 | Pirfenidone, micronised, non-micronised | SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN | 100044578;100073706 | CEP 2016-242 - Rev 01 | 2025/04/07 | Valid | Chemical | 2025/04/07 | Minor revision|CEP granted|07/04/2025; Renewal|CEP granted|03/10/2022; Minor revision|CEP granted|20/08/2021 |
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| 1722 | Flunarizine dihydrochloride | VASUDHA PHARMA CHEM LIMITED Hyderabad IN | 100011811;100018603 | CEP 2020-224 - Rev 04 | 2025/04/07 | Valid | 01/02/2027 | Chemical | 2025/04/07 | Minor revision|CEP granted|07/04/2025; Monograph revision|CEP granted|18/08/2023; Notification|CEP granted|03/02/2023; Minor revision|CEP granted|06/07/2022; New application|CEP granted|01/02/2022 |
|
| 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 | |
| 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 |
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