| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 68 | Atropine sulfate | RESONANCE LABORATORIES PRIVATE LIMITED Bengaluru IN | 100024014;100033182 | CEP 2023-234 - Rev 00 | 2026/01/19 | Valid | 19/01/2031 | Chemical | 2026/01/19 | New application|CEP granted|19/01/2026 | |
| 2445 | Adapalene | AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN | 100045727;100075371 | CEP 2022-158 - Rev 01 | 2026/01/19 | Valid | 19/06/2029 | Chemical | 2026/01/19 | Minor revision|CEP granted|19/01/2026; New application|CEP granted|19/06/2024 |
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| 1210 | Fentanyl | VERANOVA, L.P. West Deptford US | 100012273;100018937 | CEP 2000-141 - Rev 04 | 2026/01/19 | Valid | Chemical | 2026/01/19 | Minor revision|CEP granted|19/01/2026 | ||
| 110 | Zinc chloride | Merck KGaA Darmstadt DE | 100000742;100006955 | CEP 2014-168 - Rev 03 | 2026/01/19 | Valid | Chemical | 2026/01/19 | Minor revision|CEP granted|19/01/2026; Major revision|CEP granted|03/10/2022; Minor revision|CEP granted|29/11/2021; Renewal|CEP granted|27/10/2020 |
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| 698 | Warfarin sodium | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2009-041 - Rev 03 | 2026/01/19 | Valid | Chemical | 2026/01/19 | Minor revision|CEP granted|19/01/2026; Notification|Accepted - CEP remains valid|23/06/2023; Minor revision|Accepted - CEP remains valid|09/04/2020 |
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| 2762 | Capecitabine | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2014-355 - Rev 05 | 2026/01/19 | Valid | Chemical | 2026/03/26 | Minor revision|Accepted - CEP remains valid|26/03/2026; Notification|Rejected|26/02/2026; Minor revision|CEP granted|19/01/2026; Minor revision|CEP granted|20/05/2025; Minor revision|CEP granted|22/01/2025; Notification|Accepted - CEP remains valid|05/09/2023; Major revision|CEP granted|16/06/2023; Major revision|CEP granted|18/10/2022; Renewal|CEP granted|24/09/2021; Notification|CEP granted|24/07/2020 |
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| . | Bovine Calf Serum | MEDIATECH INC. Manassas US | 100051460;100090205 | CEP 2018-305 - Rev 02 | 2026/01/19 | Valid | TSE | 2026/01/19 | Major revision|CEP granted|19/01/2026; Renewal|CEP granted|03/07/2024 |
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| 2020 | Rilmenidine dihydrogen phosphate | ZENTIVA K.S. Prague CZ | 100004108;100097772 | CEP 2023-124 - Rev 01 | 2026/01/19 | Valid | 18/12/2029 | Chemical | 2026/01/19 | Notification|CEP granted|19/01/2026; New application|CEP granted|19/12/2024 |
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| 2131 | Tamsulosin hydrochloride, Ankleshwar site | ZENTIVA K.S. Prague CZ | 100004108;100097772 | CEP 2023-469 - Rev 01 | 2026/01/19 | Valid | 25/04/2029 | Chemical | 2026/01/19 | Notification|CEP granted|19/01/2026; New application|CEP granted|25/04/2024 |
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| 2768 | Fluticasone furoate | SHANDONG SIRUI PHARMACEUTICAL CO., LTD. Heze CN | 100049295;100083729 | CEP 2025-315 - Rev 00 | 2026/01/19 | Valid | 19/01/2031 | Chemical | 2026/01/19 | New application|CEP granted|19/01/2026 | |
| 14 | Calcium carbonate, Granular Grade II | SUDEEP PHARMA LIMITED Vadodara IN | 100033274;100051937 | CEP 2025-377 - Rev 00 | 2026/01/19 | Valid | 19/01/2031 | Chemical | 2026/01/19 | New application|CEP granted|19/01/2026 | |
| 292 | Riboflavin, Fermentation process | DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH | 100053293;100094111 | CEP 2000-088 - Rev 03 | 2026/01/16 | Valid | Chemical | 2026/01/16 | Minor revision|CEP granted|16/01/2026; Notification|CEP granted|17/07/2025; Minor revision|Accepted - CEP remains valid|09/08/2022 |
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| 2203 | Citalopram hydrochloride | JUBILANT BIOSYS LIMITED Mysuru IN | 100055198;100098088 | CEP 2009-205 - Rev 03 | 2026/01/16 | Valid | Chemical | 2026/01/16 | Notification|CEP granted|16/01/2026; Notification|CEP granted|24/08/2022 |
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| 2232 | Losartan potassium | JUBILANT BIOSYS LIMITED Mysuru IN | 100055198;100098088 | CEP 2009-374 - Rev 05 | 2026/01/16 | Valid | Chemical | 2026/01/16 | Notification|CEP granted|16/01/2026; Minor revision|CEP granted|03/11/2022; Notification|CEP granted|11/08/2022; Minor revision|Accepted - CEP remains valid|16/06/2022 |
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| 2465 | Irbesartan | JUBILANT BIOSYS LIMITED Mysuru IN | 100055198;100098088 | CEP 2011-087 - Rev 06 | 2026/01/16 | Valid | Chemical | 2026/01/16 | Minor revision|CEP granted|16/01/2026; Notification|CEP granted|17/10/2025; Minor revision|CEP granted|25/03/2024; Minor revision|CEP granted|23/10/2023; Notification|CEP granted|11/08/2022; Monograph revision|Accepted - CEP remains valid|28/07/2022 |
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| 2366 | Galantamine hydrobromide, Produced by a synthetic process | JUBILANT BIOSYS LIMITED Mysuru IN | 100055198;100098088 | CEP 2011-123 - Rev 03 | 2026/01/16 | Valid | Chemical | 2026/01/16 | Notification|CEP granted|16/01/2026; Notification|CEP granted|12/08/2022; Monograph revision|CEP granted|04/06/2020 |
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| 2018 | Paroxetine hydrochloride hemihydrate | JUBILANT BIOSYS LIMITED Mysuru IN | 100055198;100098088 | CEP 2009-204 - Rev 03 | 2026/01/16 | Valid | Chemical | 2026/01/16 | Notification|CEP granted|16/01/2026; Notification|CEP granted|23/08/2022 |
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| 2535 | Levetiracetam | JUBILANT BIOSYS LIMITED Mysuru IN | 100055198;100098088 | CEP 2011-159 - Rev 02 | 2026/01/16 | Valid | Chemical | 2026/01/16 | Notification|CEP granted|16/01/2026; Notification|CEP granted|23/08/2022 |
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| 1322 | Fenofibrate | VANAMALI ORGANICS PRIVATE LIMITED Hyderabad IN | 100038866;100061082 | CEP 2001-263 - Rev 09 | 2026/01/16 | Valid | Chemical | 2026/01/16 | Transfer of holdership|CEP granted|16/01/2026; Notification|CEP granted|23/10/2024; Minor revision|Accepted - CEP remains valid|28/05/2024; Minor revision|CEP granted|04/05/2023; Minor revision|Rejected|01/03/2023; Notification|Accepted - CEP remains valid|14/06/2022; Minor revision|Accepted - CEP remains valid|22/02/2022; Minor revision|CEP granted|16/10/2020 |
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| 2606 | Tadalafil | JUBILANT BIOSYS LIMITED Mysuru IN | 100055198;100098088 | CEP 2013-276 - Rev 02 | 2026/01/16 | Valid | Chemical | 2026/01/16 | Notification|CEP granted|16/01/2026; Notification|CEP granted|12/08/2022 |
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