| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2930 | Valganciclovir hydrochloride, Crystalline Type II | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2023-217 - Rev 00 | 2025/04/29 | Valid | 29/04/2030 | Chemical | 2025/09/03 | Minor revision|Accepted - CEP remains valid|03/09/2025; New application|CEP granted|29/04/2025 |
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| 2733 | Escitalopram oxalate, Process-IV | NEULAND LABORATORIES LIMITED Hyderabad IN | 100011545;100062134 | CEP 2025-005 - Rev 01 | 2025/04/29 | Valid | 05/03/2030 | Chemical | 2025/04/29 | Minor revision|CEP granted|29/04/2025; New application|CEP granted|05/03/2025 |
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| 2422 | Oseltamivir phosphate, Form-A, route code OV | MSN LIFE SCIENCES PRIVATE LIMITED Chandampet Village IN | 100018316;100027671 | CEP 2024-571 - Rev 00 | 2025/04/29 | Valid | 29/04/2030 | Chemical | 2025/04/29 | New application|CEP granted|29/04/2025 | |
| 2209 | Sulbactam sodium, Sterile | QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN | 100033695;100052910 | CEP 2024-030 - Rev 01 | 2025/04/29 | Valid | 14/03/2030 | Chemical | 2025/04/29 | Administrative procedure|CEP granted|29/04/2025; New application|CEP granted|14/03/2025 |
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| 645 | Tobramycin, Spray-dried, amorphous | LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN | 100020920;100029633 | CEP 2024-023 - Rev 01 | 2025/04/29 | Valid | 25/06/2029 | Chemical | 2026/01/22 | Monograph revision|Accepted - CEP remains valid|22/01/2026; Notification|CEP granted|29/04/2025; New application|CEP granted|25/06/2024 |
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| 1489 | Ambroxol hydrochloride, Process II | AMI LIFESCIENCES PRIVATE LIMITED Karakhadi IN | 100021822;100030527 | CEP 2023-168 - Rev 01 | 2025/04/28 | Valid | 23/08/2028 | Chemical | 2025/04/28 | Minor revision|CEP granted|28/04/2025; New application|CEP granted|23/08/2023 |
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| 2127 | Clobetasol propionate | CURIA SPAIN S.A.U. Boecillo ES | 100011649;100019586 | CEP 2011-095 - Rev 02 | 2025/04/28 | Valid | Chemical | 2025/04/28 | Minor revision|CEP granted|28/04/2025; Notification|CEP granted|25/08/2021 |
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| 2133 | Troxerutin | TOPFOND PHARMACEUTICAL CO., LTD. Zhumadian CN | 100023369;100077278 | CEP 2023-419 - Rev 00 | 2025/04/28 | Valid | 28/04/2030 | Chemical | 2025/04/28 | New application|CEP granted|28/04/2025 | |
| 38 | Levodopa | SHANDONG LUKANG PHARMACEUTICAL CO., LTD. Jining City CN | 100025471;100071013 | CEP 2022-202 - Rev 00 | 2025/04/28 | Valid | 28/04/2030 | Chemical and TSE | 2025/04/28 | New application|CEP granted|28/04/2025 | |
| . | Glutaraldehyde fixed bovine pericardium | MERIL LIFE SCIENCES PRIVATE LIMITED Vapi IN | 100054083;100095677 | CEP 2024-425 - Rev 00 | 2025/04/25 | Valid | 25/04/2030 | TSE | 2025/04/25 | New application|CEP granted|25/04/2025 | |
| 2600 | Olmesartan medoxomil | CHROMO LABORATORIES INDIA PRIVATE LIMITED Pashamylaram IN | 100038839;100060978 | CEP 2018-083 - Rev 04 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Renewal|CEP granted|25/04/2025; Minor revision|CEP granted|03/08/2023; Notification|Accepted - CEP remains valid|06/01/2023; Minor revision|Accepted - CEP remains valid|21/12/2022; Minor revision|CEP granted|06/09/2022; Monograph revision|CEP granted|06/05/2022 |
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| 2017 | Oxaliplatin, Process HER-2 | HERAEUS PRECIOUS METALS GMBH & CO. KG Hanau DE | 100012310;100021629 | CEP 2006-137 - Rev 06 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Notification|CEP granted|25/04/2025; Notification|CEP granted|02/10/2023; Notification|CEP granted|18/07/2022; Notification|CEP granted|24/03/2021 |
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| 1614 | Estradiol valerate | ASPEN OSS B.V. Oss NL | 100011619;100050602 | CEP 2009-171 - Rev 02 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Notification|CEP granted|25/04/2025 | ||
| . | Foetal Bovine Serum | GLOBAL LIFE SCIENCES SOLUTIONS NEW ZEALAND Tauranga NZ | 100052523;100092494 | CEP 2000-211 - Rev 05 | 2025/04/25 | Valid | TSE | 2025/04/25 | Notification|CEP granted|25/04/2025; Notification|CEP granted|25/02/2022; Notification|CEP granted|05/06/2020 |
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| 1517 | Flumequine | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2001-318 - Rev 05 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; Notification|Rejected|08/04/2025; Minor revision|CEP granted|16/07/2020 |
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| 944 | Piroxicam | PFIZER INC. New York US | 100004191;100077681 | CEP 2001-427 - Rev 02 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025 | ||
| 3059 | Melatonin | SWATI SPENTOSE PRIVATE LIMITED Mumbai IN | 100021605;100052219 | CEP 2023-075 - Rev 03 | 2025/04/25 | Valid | 22/05/2029 | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; Minor revision|CEP granted|17/02/2025; Notification|CEP granted|16/09/2024; New application|CEP granted|22/05/2024 |
|
| 2781 | Tolterodine tartrate | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2020-032 - Rev 01 | 2025/04/25 | Valid | 17/03/2026 | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; Minor revision|Accepted - CEP remains valid|24/08/2023; New application|CEP granted|17/03/2021 |
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| 2254 | Moxifloxacin hydrochloride | ENALTEC LABS PRIVATE LIMITED Navi Mumbai IN | 100015510;100024234 | CEP 2022-487 - Rev 00 | 2025/04/25 | Valid | 25/04/2030 | Chemical | 2025/04/25 | New application|CEP granted|25/04/2025 | |
| 2296 | Pantoprazole sodium sesquihydrate | SHOUGUANG FUKANG PHARMACEUTICAL CO., LTD. Shouguang City CN | 100017920;100052986 | CEP 2013-350 - Rev 01 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Major revision|CEP granted|25/04/2025; Renewal|CEP granted|15/09/2020 |
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