| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1075 | Budesonide, T Process | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2014-051 - Rev 02 | 2025/07/22 | Valid | Chemical | 2025/07/22 | Notification|CEP granted|22/07/2025; Notification|CEP granted|20/12/2021; Notification|Accepted - CEP remains valid|04/12/2020 |
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| 2762 | Capecitabine | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2015-078 - Rev 01 | 2025/07/22 | Valid | Chemical | 2025/07/22 | Notification|CEP granted|22/07/2025; Renewal|CEP granted|04/01/2022 |
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| 1210 | Fentanyl | SIEGFRIED GRAFTON INC. Grafton US | 100042515;100070251 | CEP 2005-044 - Rev 04 | 2025/07/22 | Valid | Chemical | 2025/07/22 | Notification|CEP granted|22/07/2025; Notification|Accepted - CEP remains valid|02/04/2024; Notification|CEP granted|27/08/2021 |
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| 1173 | Benserazide hydrochloride | BIOPHORE INDIA PHARMACEUTICALS PRIVATE LIMITED Hyderabad IN | 100028906;100063062 | CEP 2022-150 - Rev 01 | 2025/07/22 | Valid | 18/06/2030 | Chemical | 2025/07/22 | Notification|CEP granted|22/07/2025; New application|CEP granted|18/06/2025 |
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| 576 | Allopurinol | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2021-074 - Rev 03 | 2025/07/22 | Valid | 08/03/2028 | Chemical | 2025/07/22 | Minor revision|CEP granted|22/07/2025; Minor revision|CEP granted|16/09/2024; Minor revision|CEP granted|11/08/2023; Notification|Accepted - CEP remains valid|11/04/2023; New application|CEP granted|08/03/2023 |
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| 931 | Metformin Hydrochloride | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | CEP 2021-311 - Rev 01 | 2025/07/22 | Valid | 24/04/2029 | Chemical | 2025/07/22 | Minor revision|CEP granted|22/07/2025; New application|CEP granted|24/04/2024 |
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| 1551 | Nomegestrol acetate, Nomac grade C | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2015-266 - Rev 02 | 2025/07/22 | Valid | Chemical | 2025/07/22 | Minor revision|CEP granted|22/07/2025; Notification|CEP granted|20/12/2021 |
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| 688 | Spironolactone, Micronised | EUROAPI FRANCE Vertolaye FR | 100039327;100061906 | CEP 2000-167 - Rev 08 | 2025/07/22 | Valid | Chemical | 2025/07/22 | Minor revision|CEP granted|22/07/2025; Transfer of holdership|CEP granted|16/12/2021 |
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| 2154 | Telmisartan | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2010-301 - Rev 05 | 2025/07/22 | Valid | Chemical | 2025/07/22 | Notification|CEP granted|22/07/2025; Notification|CEP granted|18/08/2023; Notification|CEP granted|20/12/2021; Minor revision|CEP granted|24/06/2020 |
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| 2209 | Sulbactam sodium, Sterile, Process-II | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2024-231 - Rev 00 | 2025/07/22 | Valid | 22/07/2030 | Chemical | 2025/07/22 | New application|CEP granted|22/07/2025 | |
| 2209 | Sulbactam sodium, Sterile | ZHUHAI UNITED LABORATORIES CO., LTD. Sanzao Town CN | 100022945;100052547 | CEP 2024-428 - Rev 00 | 2025/07/22 | Valid | 22/07/2030 | Chemical | 2025/07/22 | New application|CEP granted|22/07/2025 | |
| 1275 | Ursodeoxycholic acid, Code 2618 | ICE S.P.A. Basaluzzo, Alessandria IT | 100015143;100051551 | CEP 2010-376 - Rev 03 | 2025/07/22 | Valid | Chemical and TSE | 2026/01/26 | Monograph revision|Accepted - CEP remains valid|26/01/2026; Minor revision|CEP granted|22/07/2025; Notification|CEP granted|26/04/2022; Notification|CEP granted|25/06/2020 |
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| 1710 | Bisoprolol fumarate | MEHTA API PRIVATE LIMITED Boisar IN | 100020995;100042931 | CEP 2023-208 - Rev 00 | 2025/07/22 | Valid | 22/07/2030 | Chemical | 2025/07/22 | New application|CEP granted|22/07/2025 | |
| 2631 | Rosuvastatin calcium, Micronised | MANKIND PHARMA LIMITED New Delhi IN | 100040218;100065486 | CEP 2022-060 - Rev 02 | 2025/07/22 | Valid | 26/06/2028 | Chemical | 2025/07/23 | Administrative procedure|CEP granted|23/07/2025; Notification|CEP granted|10/06/2025; New application|CEP granted|26/06/2023 |
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| 1376 | Triamcinolone | CORAL DRUGS PRIVATE LIMITED New Delhi IN | 100019182;100042823 | CEP 2022-370 - Rev 00 | 2025/07/22 | Valid | 22/07/2030 | Chemical | 2025/07/23 | New application|CEP granted|23/07/2025 | |
| 2768 | Fluticasone furoate, Process I | HOVIONE FARMACIENCIA S.A. Loures PT | 100001467;100000315 | CEP 2024-146 - Rev 00 | 2025/07/22 | Valid | 22/07/2030 | Chemical | 2025/07/23 | New application|CEP granted|23/07/2025 | |
| 383 | Chlorobutanol hemihydrate | OLPHA AS Olaine LV | 100002509;100000997 | CEP 2013-148 - Rev 02 | 2025/07/22 | Valid | Chemical | 2025/07/23 | Minor revision|CEP granted|23/07/2025; Notification|CEP granted|28/10/2024; Minor revision|Accepted - CEP remains valid|18/12/2020 |
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| 1302 | Ciclopirox olamine | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 1999-085 - Rev 09 | 2025/07/22 | Valid | Chemical | 2025/07/23 | Minor revision|CEP granted|23/07/2025; Minor revision|Accepted - CEP remains valid|04/07/2024; Minor revision|Accepted - CEP remains valid|15/03/2023; Minor revision|Accepted - CEP remains valid|28/03/2022; Minor revision|CEP granted|13/09/2021; Minor revision|CEP granted|11/01/2021 |
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| 67 | Folic acid hydrate | SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN | 100015104;100023787 | CEP 1997-076 - Rev 13 | 2025/07/22 | Valid | Chemical | 2025/07/23 | Minor revision|CEP granted|23/07/2025; Minor revision|CEP granted|05/03/2024; Monograph revision|Accepted - CEP remains valid|07/09/2022; Minor revision|CEP granted|20/05/2021 |
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| 3132 | Mirabegron | VASUDHA PHARMA CHEM LIMITED Hyderabad IN | 100011811;100018603 | CEP 2024-198 - Rev 00 | 2025/07/22 | Valid | 22/07/2030 | Chemical | 2025/07/23 | New application|CEP granted|23/07/2025 |
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