| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| . | Foetal Bovine Serum | MEDIATECH INC. Woodland US | 100051460;100090717 | CEP 2020-127 - Rev 01 | 2026/05/07 | Valid | TSE | 2026/05/07 | Renewal|CEP granted|07/05/2026; New application|CEP granted|15/02/2021 |
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| 934 | Metronidazole benzoate | BAJAJ HEALTHCARE LIMITED Thane IN | 100021782;100061986 | CEP 2023-417 - Rev 01 | 2026/05/07 | Valid | 11/09/2029 | Chemical | 2026/05/07 | Monograph revision|CEP granted|07/05/2026; New application|CEP granted|11/09/2024 |
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| 1332 | Isoprenaline hydrochloride | EMCURE PHARMACEUTICALS LIMITED Pune IN | 100011677;100099996 | CEP 2022-154 - Rev 01 | 2026/05/07 | Valid | 21/07/2028 | Chemical | 2026/05/07 | Minor revision|CEP granted|07/05/2026; New application|CEP granted|21/07/2023 |
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| 1031 | Sodium picosulfate | KREATIVE ORGANICS PRIVATE LIMITED Hyderabad IN | 100023685;100032852 | CEP 2014-020 - Rev 03 | 2026/05/07 | Valid | Chemical | 2026/05/07 | Minor revision|CEP granted|07/05/2026; Minor revision|CEP granted|20/09/2024; Major revision|CEP granted|09/09/2021; Renewal|CEP granted|23/09/2020 |
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| 661 | Cloxacillin sodium, Sterile | FRESENIUS KABI IPSUM S.R.L. Cassina de' Pecchi IT | 100015105;100057989 | CEP 1998-025 - Rev 09 | 2026/05/07 | Valid | Chemical | 2026/05/07 | Minor revision|CEP granted|07/05/2026; Major revision|CEP granted|10/06/2021; Minor revision|Accepted - CEP remains valid|06/03/2020 |
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| 931 | Metformin Hydrochloride | EXEMED PHARMACEUTICALS Vadodara IN | 100019154;100027915 | CEP 2011-328 - Rev 03 | 2026/05/07 | Valid | Chemical | 2026/05/07 | Notification|CEP granted|07/05/2026; Minor revision|Accepted - CEP remains valid|11/02/2025; Notification|Accepted - CEP remains valid|23/02/2021; Minor revision|Accepted - CEP remains valid|01/09/2020; Notification|Accepted - CEP remains valid|13/05/2020 |
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| 993 | Cholesterol, NF | CARBOGEN AMCIS B.V. Veenendaal NL | 100002010;100009870 | CEP 2001-148 - Rev 03 | 2026/05/07 | Valid | TSE | 2026/05/07 | Major revision|CEP granted|07/05/2026 | ||
| 1335 | Itraconazole | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100089573 | CEP 2011-283 - Rev 02 | 2026/05/07 | Valid | Chemical | 2026/05/07 | Notification|CEP granted|07/05/2026; Minor revision|CEP granted|05/05/2025; Minor revision|Rejected|21/02/2025 |
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| 1420 | Enalapril maleate | NEULAND LABORATORIES LIMITED Hyderabad IN | 100011545;100062134 | CEP 2003-078 - Rev 16 | 2026/05/07 | Valid | Chemical | 2026/05/07 | Notification|CEP granted|07/05/2026; Minor revision|CEP granted|25/08/2025; Minor revision|Accepted - CEP remains valid|03/10/2023; Minor revision|CEP granted|07/06/2023; Notification|CEP granted|24/03/2023; Notification|CEP granted|07/09/2021; Notification|CEP granted|04/09/2020 |
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| . | Newborn Calf Serum | HYCLONE LABORATORIES LLC. Logan US | 100012797;100022115 | CEP 2018-302 - Rev 03 | 2026/05/07 | Valid | TSE | 2026/05/07 | Notification|CEP granted|07/05/2026; Renewal|CEP granted|13/03/2024; Notification|Accepted - CEP remains valid|10/05/2022; Notification|Rejected|25/03/2022; Notification|CEP granted|24/06/2020 |
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| 2342 | Cefprozil monohydrate, Process II | QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN | 100033695;100052910 | CEP 2020-252 - Rev 01 | 2026/05/07 | Valid | Chemical | 2026/05/07 | Renewal|CEP granted|07/05/2026; New application|CEP granted|19/02/2021 |
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| 760 | Cytarabine | ASAHI KASEI FINECHEM CO., LTD. Osaka JP | 100023625;100101548 | CEP 2017-218 - Rev 04 | 2026/05/07 | Valid | Chemical | 2026/05/07 | Notification|CEP granted|07/05/2026; Minor revision|CEP granted|20/09/2024; Renewal|CEP granted|14/05/2024; Minor revision|Accepted - CEP remains valid|11/10/2022; Minor revision|CEP granted|14/06/2021 |
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| 2531 | Clopidogrel hydrogen sulfate, Form-I | PRAVEEN LABORATORIES PRIVATE LIMITED Surat IN | 100033525;100087439 | CEP 2014-176 - Rev 03 | 2026/05/07 | Valid | Chemical | 2026/05/07 | Minor revision|CEP granted|07/05/2026; Minor revision|CEP granted|15/12/2025; Minor revision|CEP granted|21/02/2024; Renewal|CEP granted|05/11/2020 |
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| 77 | Dapsone | EXTROVIS AG Baar CH | 100040194;100065405 | CEP 2022-379 - Rev 01 | 2026/05/07 | Valid | 12/06/2029 | Chemical | 2026/05/07 | Minor revision|CEP granted|07/05/2026; New application|CEP granted|12/06/2024 |
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| 2577 | Oxcarbazepine, Process-II | DASAMI LAB PRIVATE LIMITED Nalgonda IN | 100033206;100051825 | CEP 2023-348 - Rev 02 | 2026/05/07 | Valid | 29/04/2030 | Chemical | 2026/05/07 | Administrative procedure|CEP granted|07/05/2026; Minor revision|CEP granted|21/04/2026; New application|CEP granted|29/04/2025 |
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| 2215 | Iodixanol | JIANGXI BROTHER PHARMACEUTICAL CO., LTD. Jiujiang City CN | 100048879;100081715 | CEP 2025-424 - Rev 00 | 2026/05/07 | Valid | 07/05/2031 | Chemical | 2026/05/07 | New application|CEP granted|07/05/2026 | |
| 330 | Gelatin, Bovine Limed Hide Gelatin | ROUSSELOT B.V. Son En Breugel NL | 100051434;100090148 | CEP 2025-038 - Rev 00 | 2026/05/07 | Valid | 07/05/2031 | TSE | 2026/05/07 | New application|CEP granted|07/05/2026 | |
| 2423 | Valsartan | Changzhou Pharmaceutical Factory Changzhou CN | 100012704;100018611 | CEP 2025-430 - Rev 00 | 2026/05/07 | Valid | 07/05/2031 | Chemical | 2026/05/07 | New application|CEP granted|07/05/2026 | |
| 1573 | Sumatriptan succinate | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100089573 | CEP 2024-042 - Rev 01 | 2026/05/07 | Valid | 27/01/2031 | Chemical | 2026/05/07 | Notification|CEP granted|07/05/2026; New application|CEP granted|27/01/2026 |
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| 2531 | Clopidogrel hydrogen sulfate, Process B | PRAVEEN LABORATORIES PRIVATE LIMITED Jolwa Village IN | 100033525;100052476 | CEP 2017-247 - Rev 02 | 2026/05/07 | Valid | Chemical | 2026/05/07 | Minor revision|CEP granted|07/05/2026; Minor revision|CEP granted|19/03/2025; Renewal|CEP granted|19/12/2022 |
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