| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 821 | Estradiol hemihydrate, Dorog site | GEDEON RICHTER PLC. Budapest HU | 100000640;100001653 | CEP 2025-255 - Rev 00 | 2025/10/20 | Valid | 20/10/2030 | Chemical | 2025/10/20 | New application|CEP granted|20/10/2025 | |
| 2406 | Anastrozole, Form-II | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2013-172 - Rev 02 | 2025/10/17 | Valid | Chemical | 2025/10/17 | Minor revision|CEP granted|17/10/2025; Minor revision|Accepted - CEP remains valid|13/07/2023; Notification|Rejected|23/01/2023; Minor revision|CEP granted|15/12/2020 |
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| 1649 | Azithromycin, Monohydrate | JUBILANT BIOSYS LIMITED Nanjangud IN | 100055198;100098088 | CEP 2007-118 - Rev 06 | 2025/10/17 | Valid | Chemical | 2025/10/17 | Notification|CEP granted|17/10/2025; Notification|CEP granted|12/08/2022; Monograph revision|CEP granted|14/01/2022 |
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| 543 | Carbamazepine, CMZ | JUBILANT BIOSYS LIMITED Nanjangud IN | 100055198;100098088 | CEP 2011-206 - Rev 02 | 2025/10/17 | Valid | Chemical | 2025/10/17 | Notification|CEP granted|17/10/2025; Notification|CEP granted|24/08/2022 |
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| 2572 | Risedronate sodium 2.5-hydrate | JUBILANT BIOSYS LIMITED Nanjangud IN | 100055198;100098088 | CEP 2014-010 - Rev 02 | 2025/10/17 | Valid | Chemical | 2025/10/17 | Notification|CEP granted|17/10/2025; Monograph revision|Accepted - CEP remains valid|05/10/2023; Notification|CEP granted|23/08/2022 |
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| 2372 | Esomeprazole magnesium trihydrate, Powder | JUBILANT BIOSYS LIMITED Nanjangud IN | 100055198;100098088 | CEP 2023-175 - Rev 02 | 2025/10/17 | Valid | 18/08/2028 | Chemical | 2025/10/17 | Notification|CEP granted|17/10/2025; Administrative procedure|CEP granted|23/08/2023; New application|CEP granted|18/08/2023 |
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| 2766 | Exemestane, Micronised | SYNTHON B.V. Nijmegen NL | 100001342;100005475 | CEP 2022-424 - Rev 02 | 2025/10/17 | Valid | 06/10/2028 | Chemical | 2025/10/17 | Notification|CEP granted|17/10/2025; Minor revision|CEP granted|02/09/2024; New application|CEP granted|06/10/2023 |
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| 1563 | Simvastatin, Ethanol II process | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2019-179 - Rev 02 | 2025/10/17 | Valid | Chemical | 2025/10/17 | Renewal|CEP granted|17/10/2025; Notification|CEP granted|20/12/2021 |
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| 577 | Amoxicillin sodium, Sterile, Enzymatic route | SANDOZ GMBH Kundl AT | 100000546;100000450 | CEP 2025-064 - Rev 01 | 2025/10/17 | Valid | 28/03/2030 | Chemical | 2025/10/17 | Notification|CEP granted|17/10/2025; New application|CEP granted|28/03/2025 |
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| 543 | Carbamazepine, Carbamazepine CBA Powder | JUBILANT BIOSYS LIMITED Nanjangud IN | 100055198;100098088 | CEP 2024-439 - Rev 01 | 2025/10/17 | Valid | 05/03/2030 | Chemical | 2025/10/17 | Notification|CEP granted|17/10/2025; New application|CEP granted|05/03/2025 |
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| 2733 | Escitalopram oxalate | JUBILANT BIOSYS LIMITED Nanjangud IN | 100055198;100098088 | CEP 2017-082 - Rev 01 | 2025/10/17 | Valid | Chemical | 2025/10/17 | Notification|CEP granted|17/10/2025; Renewal|CEP granted|09/06/2023; Notification|CEP granted|12/08/2022 |
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| 1363 | Prilocaine Hydrochloride | MOEHS IBERICA S.L. Rubi ES | 100029092;100068825 | CEP 2025-153 - Rev 00 | 2025/10/17 | Valid | 17/10/2030 | Chemical | 2025/10/17 | New application|CEP granted|17/10/2025 | |
| 2631 | Rosuvastatin calcium, Process-II | AMOLI ORGANICS PRIVATE LIMITED Mumbai IN | 100016500;100025303 | CEP 2025-379 - Rev 00 | 2025/10/16 | Valid | 16/10/2030 | Chemical | 2025/10/16 | New application|CEP granted|16/10/2025 | |
| 3049 | Etonogestrel | CURIA SPAIN S.A.U. Boecillo ES | 100011649;100019586 | CEP 2025-093 - Rev 01 | 2025/10/16 | Valid | 19/09/2030 | Chemical | 2025/10/16 | Notification|CEP granted|16/10/2025; New application|CEP granted|19/09/2025 |
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| 1564 | Sodium alendronate trihydrate | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2008-090 - Rev 03 | 2025/10/16 | Valid | Chemical | 2025/10/16 | Minor revision|CEP granted|16/10/2025; Notification|Accepted - CEP remains valid|23/06/2023; Minor revision|CEP granted|27/04/2021 |
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| 525 | Propylthiouracil | NANTONG JINGHUA PHARMACEUTICAL CO., LTD. Nantong CN | 100018246;100052237 | CEP 2023-467 - Rev 01 | 2025/10/16 | Valid | 01/04/2030 | Chemical | 2025/10/16 | Monograph revision|CEP granted|16/10/2025; New application|CEP granted|01/04/2025 |
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| 312 | Betamethasone | MSD EUROPE BELGIUM Watermael-Boitsfort BE | 100049238;100083482 | CEP 2017-092 - Rev 02 | 2025/10/16 | Valid | Chemical | 2025/10/16 | Administrative procedure|CEP granted|16/10/2025; Minor revision|CEP granted|25/09/2025; Renewal|CEP granted|12/12/2022 |
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| 1765 | Salmeterol xinafoate | INDUSTRIALE CHIMICA S.R.L. Saronno IT | 100011692;100020331 | CEP 2013-107 - Rev 02 | 2025/10/16 | Valid | Chemical | 2025/10/16 | Notification|CEP granted|16/10/2025; Notification|Rejected|02/10/2025; Notification|CEP granted|18/03/2022 |
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| 968 | Aciclovir, Site Khazipally | AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100046306;100076393 | CEP 2021-274 - Rev 01 | 2025/10/16 | Valid | 07/10/2026 | Chemical | 2025/10/16 | Minor revision|CEP granted|16/10/2025; New application|CEP granted|07/10/2021 |
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| 729 | Naloxone hydrochloride dihydrate, Process II | NORAMCO, LLC. Wilmington US | 100048651;100080628 | CEP 2025-340 - Rev 00 | 2025/10/15 | Valid | 15/10/2030 | Chemical | 2025/10/15 | New application|CEP granted|15/10/2025 |
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