| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2631 | Rosuvastatin calcium, R1-Process | CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. Delft NL | 100002351;100005259 | CEP 2025-219 - Rev 00 | 2025/07/30 | Valid | 30/07/2030 | Chemical | 2025/07/30 | New application|CEP granted|30/07/2025 | |
| 2270 | Sildenafil citrate | SMILAX LABORATORIES LIMITED Hyderabad IN | 100011578;100021649 | CEP 2024-155 - Rev 00 | 2025/07/30 | Valid | 30/07/2030 | Chemical | 2025/07/30 | New application|CEP granted|30/07/2025 | |
| 1280 | Zolpidem tartrate | LAKE CHEMICALS PRIVATE LIMITED Bengaluru IN | 100012055;100053935 | CEP 2018-022 - Rev 02 | 2025/07/29 | Valid | Chemical | 2025/07/29 | Minor revision|CEP granted|29/07/2025; Renewal|CEP granted|03/07/2024; Monograph revision|Accepted - CEP remains valid|02/10/2020 |
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| 2021 | Terazosin hydrochloride dihydrate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2007-207 - Rev 06 | 2025/07/29 | Valid | Chemical | 2025/07/29 | Notification|CEP granted|29/07/2025; Minor revision|Accepted - CEP remains valid|01/09/2023; Monograph revision|CEP granted|19/04/2022; Notification|Accepted - CEP remains valid|17/09/2020 |
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| 755 | Carbidopa, Micronised | FERMION OY Espoo FI | 100011508;100020280 | CEP 2025-265 - Rev 00 | 2025/07/29 | Valid | 29/07/2030 | Chemical | 2025/07/29 | New application|CEP granted|29/07/2025 | |
| 2196 | Bicalutamide, Crystalline form-I, micronised and non-micronised | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | 100011732;100023530 | CEP 2012-283 - Rev 02 | 2025/07/29 | Valid | Chemical | 2025/07/29 | Minor revision|CEP granted|29/07/2025; Notification|CEP granted|10/08/2023 |
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| 1058 | Vancomycin hydrochloride, Precipitated fine powder | LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN | 100020920;100029633 | CEP 2020-119 - Rev 04 | 2025/07/29 | Valid | Chemical | 2025/07/29 | Renewal|CEP granted|29/07/2025; Monograph revision|CEP granted|29/10/2024; Notification|Accepted - CEP remains valid|10/06/2024; Administrative procedure|CEP granted|11/04/2023; Minor revision|CEP granted|31/03/2023; Minor revision|Rejected|11/01/2023; Notification|Accepted - CEP remains valid|27/05/2021; New application|CEP granted|04/08/2020 |
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| 2131 | Tamsulosin hydrochloride | SWATI SPENTOSE PRIVATE LIMITED Mumbai IN | 100021605;100052219 | CEP 2022-133 - Rev 02 | 2025/07/29 | Valid | 30/11/2028 | Chemical | 2025/07/29 | Minor revision|CEP granted|29/07/2025; Notification|CEP granted|16/09/2024; New application|CEP granted|30/11/2023 |
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| 703 | Atenolol | KOPRAN RESEARCH LABORATORIES LIMITED Mumbai IN | 100033667;100081898 | CEP 1998-017 - Rev 08 | 2025/07/29 | Valid | Chemical | 2025/07/29 | Minor revision|CEP granted|29/07/2025; Minor revision|CEP granted|20/06/2024; Major revision|CEP granted|12/03/2021 |
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| 2735 | Gadobutrol monohydrate | WEINAN MANARECO PHARMACEUTICAL CO., LTD. Weinan CN | 100052364;100092209 | CEP 2024-388 - Rev 00 | 2025/07/29 | Valid | 29/07/2030 | Chemical | 2025/07/29 | New application|CEP granted|29/07/2025 | |
| 2932 | Rivaroxaban, Micronised, non-micronised | SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN | 100023303;100032437 | CEP 2020-327 - Rev 02 | 2025/07/29 | Valid | 25/07/2027 | Chemical | 2025/07/29 | Minor revision|CEP granted|29/07/2025; Minor revision|CEP granted|11/01/2024; Minor revision|Accepted - CEP remains valid|07/08/2023; New application|CEP granted|25/07/2022 |
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| 2132 | Torasemide, Form-I | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2019-255 - Rev 02 | 2025/07/29 | Valid | 26/08/2027 | Chemical | 2025/07/29 | Minor revision|CEP granted|29/07/2025; Minor revision|CEP granted|08/02/2023 |
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| 574 | Cholecalciferol concentrate (powder form), 100 000 IU/g, with all-rac-α-tocopherol and sodium ascorbate | FERMENTA BIOTECH LIMITED Thane (W) IN | 100018502;100042408 | CEP 2024-588 - Rev 00 | 2025/07/29 | Valid | 29/07/2030 | Chemical and TSE | 2025/07/29 | New application|CEP granted|29/07/2025 | |
| 2288 | Citalopram hydrobromide | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2009-043 - Rev 03 | 2025/07/29 | Valid | Chemical | 2025/07/29 | Minor revision|CEP granted|29/07/2025; Notification|CEP granted|03/01/2024; Minor revision|Accepted - CEP remains valid|07/03/2022 |
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| 234 | Norethisterone, Micronised | VALDEPHARM Val de Reuil FR | 100011898;100018788 | CEP 2011-094 - Rev 04 | 2025/07/29 | Valid | Chemical | 2025/07/29 | Notification|CEP granted|29/07/2025; Notification|CEP granted|05/09/2022; Minor revision|CEP granted|04/03/2022; Minor revision|CEP granted|21/04/2021 |
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| 2814 | Thiocolchicoside hydrate | SARV BIO LABS PRIVATE LIMITED Sirmaur IN | 100039294;100061855 | CEP 2023-024 - Rev 00 | 2025/07/29 | Valid | 29/07/2030 | Chemical | 2025/07/29 | New application|CEP granted|29/07/2025 | |
| 1794 | Paclitaxel, Produced by fermentation - Site Agno | PHYTON BIOTECH LLC Delta CA | 100014889;100038370 | CEP 2024-022 - Rev 01 | 2025/07/29 | Valid | 16/07/2029 | Chemical | 2025/07/29 | Minor revision|CEP granted|29/07/2025; New application|CEP granted|16/07/2024 |
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| 1445 | Magnesium aspartate dihydrate | DR. PAUL LOHMANN GMBH & CO. KGAA Emmerthal DE | 100022728;100031429 | CEP 2013-042 - Rev 01 | 2025/07/29 | Valid | Chemical | 2025/07/29 | Minor revision|CEP granted|29/07/2025 | ||
| 1614 | Estradiol valerate, Non-micronised and micronised | ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD. Taizhou CN | 100022759;100031459 | CEP 2023-362 - Rev 00 | 2025/07/29 | Valid | 29/07/2030 | Chemical | 2025/07/29 | New application|CEP granted|29/07/2025 | |
| 2931 | Sorafenib tosilate, Form-III | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2021-324 - Rev 02 | 2025/07/29 | Valid | 15/09/2027 | Chemical | 2025/07/29 | Monograph revision|CEP granted|29/07/2025; Minor revision|CEP granted|25/11/2024; New application|CEP granted|15/09/2022 |
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