| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2423 | Valsartan | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2010-100 - Rev 06 | 2025/09/22 | Valid | Chemical | 2025/09/22 | Minor revision|CEP granted|22/09/2025; Minor revision|CEP granted|18/11/2022; Minor revision|Accepted - CEP remains valid|15/06/2022; Minor revision|CEP granted|01/12/2020; Minor revision|Accepted - CEP remains valid|19/05/2020 |
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| 1442 | Leuprorelin | CHEMI S.P.A. Patrica IT | 100000347;100009242 | CEP 2008-115 - Rev 05 | 2025/09/22 | Valid | Chemical | 2025/09/22 | Minor revision|CEP granted|22/09/2025; Minor revision|CEP granted|10/03/2022; Notification|Rejected|30/11/2021; Minor revision|Accepted - CEP remains valid|28/05/2020 |
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| 533 | Triamcinolone acetonide | AVIK PHARMACEUTICAL LIMITED Vapi IN | 100023327;100041968 | CEP 2018-231 - Rev 01 | 2025/09/22 | Valid | Chemical | 2025/09/22 | Renewal|CEP granted|22/09/2025; Notification|Accepted - CEP remains valid|17/06/2022 |
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| 687 | Salbutamol sulfate, Micronised | MELODY HEALTHCARE PRIVATE LIMITED Mumbai IN | 100014822;100073679 | CEP 2020-063 - Rev 03 | 2025/09/22 | Valid | Chemical | 2025/09/22 | Renewal|CEP granted|22/09/2025; Monograph revision|CEP granted|25/03/2024; Minor revision|CEP granted|23/03/2022; New application|CEP granted|21/10/2020 |
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| 2333 | Fluvastatin sodium, Crystalline-2 | BIOCON LIMITED Bengaluru IN | 100011487;100018595 | CEP 2022-130 - Rev 02 | 2025/09/22 | Valid | 15/06/2027 | Chemical | 2025/09/22 | Minor revision|CEP granted|22/09/2025; Administrative procedure|CEP granted|23/06/2022; New application|CEP granted|15/06/2022 |
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| 1300 | Cefuroxime axetil, Amorphous | TITAN PHARMACEUTICAL CO., LTD. (GUANGDONG) Heyuan City CN | 100024682;100033865 | CEP 2017-034 - Rev 01 | 2025/09/22 | Valid | Chemical | 2025/09/22 | Minor revision|CEP granted|22/09/2025; Renewal|CEP granted|20/04/2023; Minor revision|CEP granted|02/09/2021; Minor revision|CEP granted|23/04/2021 |
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| 2333 | Fluvastatin sodium, Amorphous-2 | BIOCON LIMITED Bengaluru IN | 100011487;100018595 | CEP 2022-139 - Rev 02 | 2025/09/22 | Valid | 22/07/2027 | Chemical | 2025/09/22 | Minor revision|CEP granted|22/09/2025; Administrative procedure|CEP granted|08/08/2022; New application|CEP granted|22/07/2022 |
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| 798 | Fusidic acid, Process B | FUJIAN COMHONY BIOTECHNOLOGY CO., LTD. Fuqing CN | 100043888;100072481 | CEP 2022-330 - Rev 02 | 2025/09/22 | Valid | 28/04/2028 | Chemical | 2025/09/22 | Minor revision|CEP granted|22/09/2025; Minor revision|CEP granted|15/10/2024; New application|CEP granted|28/04/2023 |
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| 848 | Sodium fusidate, Process B | FUJIAN COMHONY BIOTECHNOLOGY CO., LTD. Fuqing CN | 100043888;100072481 | CEP 2022-369 - Rev 02 | 2025/09/22 | Valid | 28/04/2028 | Chemical | 2025/09/22 | Minor revision|CEP granted|22/09/2025; Minor revision|CEP granted|04/11/2024; New application|CEP granted|28/04/2023 |
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| 1276 | Vindesine sulfate | MINAKEM Dunkerque FR | 100032366;100056463 | CEP 2025-393 - Rev 00 | 2025/09/22 | Valid | 22/09/2030 | Chemical | 2025/09/22 | New application|CEP granted|22/09/2025 | |
| 2191 | Atorvastatin calcium, Process 4, polymorphic form-I | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2024-238 - Rev 02 | 2025/09/22 | Valid | 04/10/2029 | Chemical | 2025/09/22 | Major revision|CEP granted|22/09/2025; Notification|CEP granted|26/05/2025; New application|CEP granted|07/10/2024 |
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| 1472 | Sodium hyaluronate, Intrinsic viscosity 1.55 m3/kg, by fermentation, for parenteral administration including intra-articular administration and for intra-ocular use | AMHWA BIOPHARM CO., LTD. Binzhou CN | 100054851;100097324 | CEP 2018-285 - Rev 02 | 2025/09/19 | Valid | Chemical | 2025/09/19 | Renewal|CEP granted|19/09/2025; Notification|CEP granted|21/06/2022 |
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| 2737 | Zolmitriptan | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2020-422 - Rev 03 | 2025/09/19 | Valid | 18/05/2027 | Chemical | 2025/09/19 | Notification|CEP granted|19/09/2025; Notification|CEP granted|15/07/2024; Minor revision|CEP granted|13/10/2023; Minor revision|Accepted - CEP remains valid|03/08/2023; New application|CEP granted|18/05/2022 |
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| 2465 | Irbesartan, Process II | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2021-100 - Rev 04 | 2025/09/19 | Valid | 27/09/2026 | Chemical | 2025/09/19 | Notification|CEP granted|19/09/2025; Minor revision|Accepted - CEP remains valid|16/12/2024; Notification|CEP granted|19/07/2024; Minor revision|CEP granted|28/04/2023; Minor revision|CEP granted|12/07/2022; New application|CEP granted|27/09/2021 |
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| 2585 | Rizatriptan benzoate | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2011-299 - Rev 04 | 2025/09/19 | Valid | Chemical | 2025/09/19 | Notification|CEP granted|19/09/2025; Notification|CEP granted|15/07/2024 |
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| 2103 | Propafenone hydrochloride | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2008-100 - Rev 05 | 2025/09/19 | Valid | Chemical | 2025/09/19 | Notification|CEP granted|19/09/2025; Notification|CEP granted|11/07/2024; Minor revision|Accepted - CEP remains valid|09/10/2020 |
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| 1084 | Cetirizine dihydrochloride | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2000-031 - Rev 13 | 2025/09/19 | Valid | Chemical | 2025/09/19 | Notification|CEP granted|19/09/2025; Notification|CEP granted|19/07/2024; Minor revision|Accepted - CEP remains valid|29/04/2024; Minor revision|CEP granted|09/03/2022 |
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| 2601 | Pioglitazone hydrochloride | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2012-315 - Rev 02 | 2025/09/19 | Valid | Chemical | 2025/09/19 | Notification|CEP granted|19/09/2025; Notification|CEP granted|11/07/2024; Minor revision|Accepted - CEP remains valid|01/06/2021 |
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| 2465 | Irbesartan | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2010-124 - Rev 09 | 2025/09/19 | Valid | Chemical | 2025/09/19 | Notification|CEP granted|19/09/2025; Minor revision|Accepted - CEP remains valid|19/12/2024; Notification|CEP granted|19/07/2024; Minor revision|CEP granted|26/04/2023; Major revision|CEP granted|26/07/2022; Major revision|CEP granted|10/06/2021 |
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| 1756 | Lamotrigine | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2009-157 - Rev 03 | 2025/09/19 | Valid | Chemical | 2025/09/19 | Notification|CEP granted|19/09/2025; Notification|CEP granted|12/07/2024 |
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