| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 3139 | Brivaracetam | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2024-017 - Rev 00 | 2025/09/10 | Valid | 10/09/2030 | Chemical | 2025/09/10 | New application|CEP granted|10/09/2025 | |
| 921 | Ketoconazole | AARTI DRUGS LIMITED Mumbai IN | 100014953;100023652 | CEP 2023-309 - Rev 00 | 2025/09/10 | Valid | 10/09/2030 | Chemical | 2025/09/10 | New application|CEP granted|10/09/2025 | |
| 77 | Dapsone | NURAY CHEMICALS PRIVATE LIMITED Thiruvallur IN | 100048890;100081754 | CEP 2023-396 - Rev 00 | 2025/09/10 | Valid | 10/09/2030 | Chemical | 2025/09/10 | New application|CEP granted|10/09/2025 | |
| 3095 | Dabigatran etexilate mesilate, Form-I | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2024-081 - Rev 00 | 2025/09/10 | Valid | 10/09/2030 | Chemical | 2025/09/10 | New application|CEP granted|10/09/2025 | |
| . | Bovine pericardium | SHANGHAI CINGULAR BIOTECH CORPORATION Shanghai CN | 100053718;100095010 | CEP 2025-056 - Rev 00 | 2025/09/10 | Valid | 10/09/2030 | TSE | 2025/09/10 | New application|CEP granted|10/09/2025 | |
| 2296 | Pantoprazole sodium sesquihydrate | SARACA LABORATORIES LIMITED Srikakulam IN | 100017715;100082033 | CEP 2024-107 - Rev 00 | 2025/09/10 | Valid | 10/09/2030 | Chemical | 2025/09/10 | New application|CEP granted|10/09/2025 | |
| 2201 | Carprofen for veterinary use | ZENFOLD SUSTAINABLE TECHNOLOGIES PRIVATE LIMITED Bangalore IN | 100051186;100089606 | CEP 2024-284 - Rev 00 | 2025/09/10 | Valid | 10/09/2030 | Chemical | 2025/09/10 | New application|CEP granted|10/09/2025 | |
| 2778 | Sitagliptin phosphate monohydrate | AMOLI ORGANICS PRIVATE LIMITED Mumbai IN | 100016500;100025303 | CEP 2024-161 - Rev 00 | 2025/09/10 | Valid | 10/09/2030 | Chemical | 2025/09/10 | New application|CEP granted|10/09/2025 | |
| 578 | Ampicillin sodium, Sterile (Process B) | ZHUHAI UNITED LABORATORIES CO., LTD. Sanzao Town CN | 100022945;100052547 | CEP 2024-414 - Rev 00 | 2025/09/10 | Valid | 10/09/2030 | Chemical | 2025/09/10 | New application|CEP granted|10/09/2025 | |
| 1028 | Metoprolol tartrate, Process-II | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2025-238 - Rev 00 | 2025/09/10 | Valid | 10/09/2030 | Chemical | 2025/09/10 | New application|CEP granted|10/09/2025 | |
| 1734 | Terbinafine hydrochloride | SHANDONG BOYUAN PHARMACEUTICAL CO., LTD. Jinan City CN | 100037406;100076812 | CEP 2024-205 - Rev 00 | 2025/09/10 | Valid | 10/09/2030 | Chemical | 2025/09/10 | New application|CEP granted|10/09/2025 | |
| 2970 | Almotriptan malate | SMS PHARMACEUTICALS LIMITED Hyderabad IN | 100011780;100061058 | CEP 2024-417 - Rev 00 | 2025/09/10 | Valid | 10/09/2030 | Chemical | 2025/09/10 | New application|CEP granted|10/09/2025 | |
| 1558 | Propofol | NEULAND LABORATORIES LIMITED Hyderabad IN | 100011545;100062134 | CEP 2013-202 - Rev 04 | 2025/09/09 | Valid | Chemical | 2025/09/09 | Minor revision|CEP granted|09/09/2025; Minor revision|CEP granted|17/01/2024; Notification|CEP granted|28/03/2023; Minor revision|Accepted - CEP remains valid|16/09/2022; Notification|CEP granted|06/12/2021; Minor revision|Accepted - CEP remains valid|14/09/2021 |
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| 2270 | Sildenafil citrate | RAKSHIT PHARMACEUTICALS LIMITED Anakapalli District IN | 100039283;100061839 | CEP 2014-361 - Rev 02 | 2025/09/09 | Valid | Chemical | 2025/09/09 | Major revision|CEP granted|09/09/2025; Notification|CEP granted|11/01/2023; Renewal|CEP granted|06/09/2021; Minor revision|Accepted - CEP remains valid|16/11/2020 |
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| 806 | Arginine | AMINO GMBH Frellstedt DE | 100011599;100021107 | CEP 2016-188 - Rev 01 | 2025/09/09 | Valid | Chemical | 2025/09/09 | Minor revision|CEP granted|09/09/2025; Renewal|CEP granted|19/05/2022 |
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| 2372 | Esomeprazole magnesium trihydrate, Unit IV | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100029297 | CEP 2020-343 - Rev 01 | 2025/09/09 | Valid | 18/01/2026 | Chemical | 2025/09/09 | Minor revision|CEP granted|09/09/2025; New application|CEP granted|18/01/2021 |
|
| 253 | Ascorbic acid | CSPC WEISHENG PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. Shijiazhuang City CN | 100024035;100082015 | CEP 2004-019 - Rev 07 | 2025/09/09 | Valid | Chemical | 2025/10/13 | Notification|Accepted - CEP remains valid|13/10/2025; Minor revision|CEP granted|09/09/2025; Notification|Accepted - CEP remains valid|05/03/2025; Monograph revision|Accepted - CEP remains valid|18/08/2023; Notification|Accepted - CEP remains valid|19/04/2023; Notification|Accepted - CEP remains valid|24/11/2022; Notification|CEP granted|21/09/2022; Minor revision|Accepted - CEP remains valid|14/06/2022; Notification|Rejected|22/04/2022; Minor revision|Accepted - CEP remains valid|25/01/2022; Notification|Accepted - CEP remains valid|12/08/2021; Notification|Accepted - CEP remains valid|01/04/2021; Minor revision|Accepted - CEP remains valid|13/08/2020; Minor revision|Abandoned|16/04/2020; Notification|CEP granted|06/03/2020 |
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| 2600 | Olmesartan medoxomil, Micronised, non-micronised | CPL PHARMACEUTICALS PRIVATE LIMITED Ahmedabad IN | 100048075;100079517 | CEP 2023-089 - Rev 03 | 2025/09/09 | Valid | 15/10/2029 | Chemical | 2025/10/02 | Major revision|Rejected|02/10/2025; Administrative procedure|CEP granted|09/09/2025; Minor revision|CEP granted|28/08/2025; Minor revision|CEP granted|05/12/2024; New application|CEP granted|15/10/2024 |
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| 96 | Mercaptopurine monohydrate | AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN | 100045727;100075371 | CEP 2021-275 - Rev 01 | 2025/09/09 | Valid | 09/08/2028 | Chemical | 2025/12/17 | Notification|Accepted - CEP remains valid|17/12/2025; Minor revision|CEP granted|09/09/2025; Monograph revision|Accepted - CEP remains valid|22/01/2025; New application|CEP granted|09/08/2023 |
|
| 2535 | Levetiracetam, Form I | AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100046306;100076393 | CEP 2021-196 - Rev 01 | 2025/09/09 | Valid | 13/07/2026 | Chemical | 2025/09/09 | Minor revision|CEP granted|09/09/2025; New application|CEP granted|13/07/2021 |
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