| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2598 | Levofloxacin hemihydrate | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | CEP 2021-448 - Rev 02 | 2025/08/21 | Valid | 02/07/2029 | Chemical | 2025/08/21 | Minor revision|CEP granted|21/08/2025; Major revision|CEP granted|10/02/2025; New application|CEP granted|02/07/2024 |
|
| 2269 | Sevoflurane, Recovered | EXDRA GMBH Grafing bei München DE | 100044971;100074267 | CEP 2022-208 - Rev 00 | 2025/08/21 | Valid | 21/08/2030 | Chemical | 2025/08/21 | New application|CEP granted|21/08/2025 | |
| 2777 | Pregabalin | SYMED LABS LIMITED Hyderabad IN | 100018727;100053490 | CEP 2023-386 - Rev 00 | 2025/08/21 | Valid | 21/08/2030 | Chemical | 2025/08/21 | New application|CEP granted|21/08/2025 | |
| 391 | Furosemide | HEM-DEEP ORGANICS PRIVATE LIMITED Ankleshwar IN | 100048515;100080399 | CEP 2023-331 - Rev 00 | 2025/08/21 | Valid | 21/08/2030 | Chemical | 2025/08/21 | New application|CEP granted|21/08/2025 | |
| 2777 | Pregabalin, Process VI | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2025-282 - Rev 00 | 2025/08/21 | Valid | 21/08/2030 | Chemical | 2025/08/21 | New application|CEP granted|21/08/2025 | |
| 575 | Cholecalciferol concentrate (oily form), 1 000 000 IU/g, in refined maize oil | DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH | 100053293;100094111 | CEP 2023-403 - Rev 02 | 2025/08/21 | Valid | 02/09/2029 | Chemical and TSE | 2025/08/21 | Minor revision|CEP granted|21/08/2025; Notification|CEP granted|17/07/2025; New application|CEP granted|02/09/2024 |
|
| 2778 | Sitagliptin phosphate monohydrate, Enzymatic method | RUYUAN HEC PHARM CO., LTD. Shaoguan CN | 100023129;100031882 | CEP 2024-352 - Rev 01 | 2025/08/21 | Valid | 03/10/2029 | Chemical | 2025/08/21 | Minor revision|CEP granted|21/08/2025; New application|CEP granted|03/10/2024 |
|
| 429 | Progesterone, Process 2, milled | SHAANXI HANJIANG PHARMACEUTICAL GROUP CO., LTD. Hanzhong CN | 100012369;100079669 | CEP 2024-553 - Rev 00 | 2025/08/21 | Valid | 21/08/2030 | Chemical | 2025/08/21 | New application|CEP granted|21/08/2025 | |
| 2779 | Solifenacin succinate | OPTIMUS DRUGS PRIVATE LIMITED Hyderabad IN | 100020646;100092226 | CEP 2019-032 - Rev 03 | 2025/08/20 | Valid | Chemical | 2025/08/20 | Administrative procedure|CEP granted|20/08/2025; Renewal|CEP granted|31/07/2025; Major revision|Rejected|27/06/2024; Minor revision|CEP granted|11/04/2022 |
||
| 1573 | Sumatriptan succinate | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2009-139 - Rev 02 | 2025/08/20 | Valid | Chemical | 2025/08/20 | Minor revision|CEP granted|20/08/2025 | ||
| 2594 | Duloxetine hydrochloride | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2012-305 - Rev 03 | 2025/08/20 | Valid | Chemical | 2025/08/20 | Notification|CEP granted|20/08/2025; Minor revision|Accepted - CEP remains valid|26/01/2024; Minor revision|CEP granted|12/01/2023; Minor revision|Accepted - CEP remains valid|02/08/2021; Minor revision|CEP granted|22/04/2021 |
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| 2631 | Rosuvastatin calcium | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100029297 | CEP 2018-227 - Rev 01 | 2025/08/20 | Valid | Chemical | 2025/08/20 | Renewal|CEP granted|20/08/2025 | ||
| 60 | Trimethoprim, Powder, micronised | ANDHRA ORGANICS LIMITED Srikakulam IN | 100023796;100032964 | CEP 2020-157 - Rev 02 | 2025/08/20 | Valid | 21/07/2027 | Chemical | 2025/08/20 | Minor revision|CEP granted|20/08/2025; Monograph revision|CEP granted|04/01/2024; New application|CEP granted|21/07/2022 |
|
| 2154 | Telmisartan, Process-II | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2020-388 - Rev 02 | 2025/08/20 | Valid | 15/03/2026 | Chemical | 2025/08/20 | Minor revision|CEP granted|20/08/2025; Minor revision|CEP granted|07/10/2021; New application|CEP granted|15/03/2021 |
|
| 1281 | Aceclofenac, Standard, fine, micronised | RANKE QUIMICA, S.A. Sant Andreu de la Barca ES | 100011757;100054672 | CEP 2023-341 - Rev 00 | 2025/08/20 | Valid | 20/08/2030 | Chemical | 2025/08/20 | New application|CEP granted|20/08/2025 | |
| 57 | Tetracaine hydrochloride | SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO., LTD. Dezhou City CN | 100048410;100080174 | CEP 2024-442 - Rev 00 | 2025/08/20 | Valid | 20/08/2030 | Chemical | 2025/08/20 | New application|CEP granted|20/08/2025 | |
| 1385 | Acitretin, Process 2 | CHONGQING HUAPONT SHENGCHEM PHARMACEUTICAL CO., LTD. Chongqing CN | 100024073;100088372 | CEP 2021-012 - Rev 01 | 2025/08/20 | Valid | 30/11/2027 | Chemical | 2025/08/20 | Minor revision|CEP granted|20/08/2025; New application|CEP granted|30/11/2022 |
|
| 2932 | Rivaroxaban, Process II (Micronised) | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2024-014 - Rev 01 | 2025/08/20 | Valid | 24/07/2029 | Chemical | 2025/08/20 | Minor revision|CEP granted|20/08/2025; New application|CEP granted|24/07/2024 |
|
| 429 | Progesterone, Process III | ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD. Taizhou CN | 100022759;100031459 | CEP 2025-150 - Rev 00 | 2025/08/20 | Valid | 20/08/2030 | Chemical | 2025/08/20 | New application|CEP granted|20/08/2025 | |
| 967 | Acetylcysteine | ZACH SYSTEM Avrillé FR | 100012282;100021396 | CEP 2016-311 - Rev 01 | 2025/08/19 | Valid | Chemical | 2025/10/24 | Minor revision|Accepted - CEP remains valid|24/10/2025; Minor revision|CEP granted|19/08/2025; Renewal|CEP granted|07/02/2022; Monograph revision|Accepted - CEP remains valid|08/01/2021; Minor revision|CEP granted|15/10/2020 |
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