| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 685 | Povidone, K12 | BOAI NKY MEDICAL HOLDINGS LTD. Jiaozuo CN | 100051122;100089488 | CEP 2024-232 - Rev 00 | 2025/07/07 | Valid | 07/07/2030 | Chemical | 2025/07/07 | New application|CEP granted|07/07/2025 | |
| 627 | Nifedipine | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 1999-150 - Rev 06 | 2025/07/04 | Valid | Chemical | 2025/07/04 | Notification|CEP granted|04/07/2025; Notification|CEP granted|05/01/2022; Minor revision|CEP granted|17/06/2021 |
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| 851 | Pentoxifylline | SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN | 100032307;100078783 | CEP 2000-127 - Rev 07 | 2025/07/04 | Valid | Chemical | 2025/07/04 | Major revision|CEP granted|04/07/2025; Monograph revision|CEP granted|04/06/2020 |
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| 2173 | Gabapentin, Butanol process | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2013-327 - Rev 03 | 2025/07/04 | Valid | Chemical | 2025/07/04 | Notification|CEP granted|04/07/2025; Notification|CEP granted|28/02/2022; Minor revision|CEP granted|28/04/2021 |
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| 2154 | Telmisartan | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2009-229 - Rev 02 | 2025/07/04 | Valid | Chemical | 2025/07/04 | Minor revision|CEP granted|04/07/2025 | ||
| 653 | Baclofen | MEDILUX LABORATORIES PRIVATE LIMITED Pithampur IN | 100023732;100032901 | CEP 2017-133 - Rev 02 | 2025/07/04 | Valid | Chemical | 2025/07/04 | Monograph revision|CEP granted|04/07/2025; Renewal|CEP granted|19/02/2024 |
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| 687 | Salbutamol sulfate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2020-100 - Rev 03 | 2025/07/04 | Valid | 14/09/2026 | Chemical | 2026/02/24 | Minor revision|Rejected|24/02/2026; Notification|CEP granted|04/07/2025; Notification|CEP granted|24/10/2024; Monograph revision|Accepted - CEP remains valid|01/02/2024; Notification|CEP granted|20/12/2021; New application|CEP granted|14/09/2021 |
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| 2766 | Exemestane | CORAL DRUGS PRIVATE LIMITED New Delhi IN | 100019182;100042823 | CEP 2023-032 - Rev 00 | 2025/07/04 | Valid | 04/07/2030 | Chemical | 2025/07/04 | New application|CEP granted|04/07/2025 | |
| 1648 | Thioctic acid, Type II | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2025-138 - Rev 00 | 2025/07/04 | Valid | 04/07/2030 | Chemical | 2025/07/04 | New application|CEP granted|04/07/2025 | |
| 3095 | Dabigatran etexilate mesilate, Micronised and non-micronised | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2023-458 - Rev 00 | 2025/07/04 | Valid | 04/07/2030 | Chemical | 2026/01/26 | Notification|Accepted - CEP remains valid|26/01/2026; New application|CEP granted|04/07/2025 |
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| 1275 | Ursodeoxycholic acid | CHANGDE YUNGANG BIOTECHNOLOGY CO. LTD. Changde CN | 100048318;100079973 | CEP 2023-296 - Rev 00 | 2025/07/04 | Valid | 04/07/2030 | Chemical | 2025/07/04 | New application|CEP granted|04/07/2025 | |
| 3036 | Teriflunomide | MAPRIMED S.A. Buenos Aires AR | 100012039;100018552 | CEP 2022-005 - Rev 01 | 2025/07/04 | Valid | 05/05/2028 | Chemical | 2025/07/04 | Minor revision|CEP granted|04/07/2025; Minor revision|Accepted - CEP remains valid|17/11/2023; New application|CEP granted|05/05/2023 |
|
| 2306 | Gemcitabine hydrochloride | SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN | 100044578;100073706 | CEP 2006-222 - Rev 02 | 2025/07/03 | Valid | Chemical | 2025/07/03 | Minor revision|CEP granted|03/07/2025; Minor revision|CEP granted|23/02/2023 |
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| 2585 | Rizatriptan benzoate | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2011-201 - Rev 04 | 2025/07/03 | Valid | Chemical | 2025/07/03 | Minor revision|CEP granted|03/07/2025; Minor revision|CEP granted|07/05/2024; Notification|CEP granted|05/01/2024; Minor revision|Accepted - CEP remains valid|17/06/2022; Monograph revision|CEP granted|23/02/2021 |
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| 2531 | Clopidogrel hydrogen sulfate, Form I | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2011-152 - Rev 05 | 2025/07/03 | Valid | Chemical | 2025/07/03 | Minor revision|CEP granted|03/07/2025; Minor revision|CEP granted|20/12/2024; Major revision|CEP granted|28/04/2023; Notification|CEP granted|07/07/2022; Minor revision|Accepted - CEP remains valid|29/06/2020 |
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| 1611 | Diosmin | SICHUAN XIELI PHARMACEUTICAL CO., LTD. Pengzhou CN | 100017947;100052361 | CEP 2013-229 - Rev 02 | 2025/07/03 | Valid | Chemical | 2025/07/03 | Minor revision|CEP granted|03/07/2025; Minor revision|CEP granted|03/06/2025; Minor revision|Accepted - CEP remains valid|14/02/2023; Minor revision|Accepted - CEP remains valid|19/01/2021; Notification|Rejected|20/10/2020; Minor revision|Accepted - CEP remains valid|24/08/2020 |
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| 654 | Beclometasone dipropionate, Micronised, non micronised | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2003-254 - Rev 07 | 2025/07/03 | Valid | Chemical | 2025/07/03 | Notification|CEP granted|03/07/2025; Notification|CEP granted|17/08/2023; Notification|CEP granted|04/01/2022; Minor revision|CEP granted|22/01/2021 |
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| 2780 | Temozolomide | SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN | 100044578;100073706 | CEP 2016-277 - Rev 01 | 2025/07/03 | Valid | Chemical | 2025/07/03 | Minor revision|CEP granted|03/07/2025; Renewal|CEP granted|12/07/2022; Monograph revision|Accepted - CEP remains valid|24/09/2020 |
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| 1524 | Gliclazide | SOHAN HEALTHCARE PVT. LTD. Pune IN | 100024454;100033626 | CEP 2020-237 - Rev 01 | 2025/07/03 | Valid | 02/05/2028 | Chemical | 2025/07/03 | Major revision|CEP granted|03/07/2025; New application|CEP granted|02/05/2023 |
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| 2631 | Rosuvastatin calcium | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2016-097 - Rev 02 | 2025/07/03 | Valid | Chemical | 2026/02/27 | Major revision|Rejected|27/02/2026; Notification|CEP granted|03/07/2025; Notification|CEP granted|08/02/2023; Renewal|CEP granted|02/09/2022; Major revision|CEP granted|28/01/2021; Minor revision|Rejected|05/10/2020; Monograph revision|CEP granted|25/06/2020 |
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