| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2869 | Fipronil for veterinary use | HUBEI MASTEAM BIO-TECH CO., LTD. Wuxue City CN | 100044745;100073954 | CEP 2023-280 - Rev 00 | 2025/07/25 | Valid | 25/07/2030 | Chemical | 2025/07/25 | New application|CEP granted|25/07/2025 | |
| 2751 | Valaciclovir hydrochloride hydrate, Micronised and non-micronised | AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100046306;100076393 | CEP 2020-059 - Rev 03 | 2025/07/25 | Valid | 19/02/2026 | Chemical | 2025/07/25 | Minor revision|CEP granted|25/07/2025; Minor revision|CEP granted|25/03/2025; Minor revision|CEP granted|17/02/2022; New application|CEP granted|19/02/2021 |
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| 1188 | Cefixime, Process 2 | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2011-243 - Rev 04 | 2025/07/25 | Valid | Chemical | 2025/07/25 | Minor revision|CEP granted|25/07/2025; Notification|Rejected|02/06/2025; Notification|CEP granted|13/12/2023; Minor revision|CEP granted|14/09/2023; Major revision|CEP granted|18/01/2023; Minor revision|Accepted - CEP remains valid|01/09/2020 |
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| 3132 | Mirabegron | LEWENS LABS PRIVATE LIMITED Dahej IN | 100042706;100070597 | CEP 2024-344 - Rev 00 | 2025/07/25 | Valid | 25/07/2030 | Chemical | 2025/07/25 | New application|CEP granted|25/07/2025 | |
| 533 | Triamcinolone acetonide | HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN | 100016183;100024971 | CEP 2024-217 - Rev 00 | 2025/07/25 | Valid | 25/07/2030 | Chemical | 2025/07/25 | New application|CEP granted|25/07/2025 | |
| 2422 | Oseltamivir phosphate | BEIJING JINCHENG TAIER PHARMACEUTICAL CO., LTD. Beiwu Town CN | 100049616;100085976 | CEP 2023-418 - Rev 00 | 2025/07/25 | Valid | 25/07/2030 | Chemical | 2025/07/25 | New application|CEP granted|25/07/2025 | |
| 2598 | Levofloxacin hemihydrate | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2020-269 - Rev 02 | 2025/07/25 | Valid | 18/05/2027 | Chemical | 2025/07/25 | Notification|CEP granted|25/07/2025; Administrative procedure|CEP granted|26/09/2024; Minor revision|Accepted - CEP remains valid|24/09/2024; Minor revision|Accepted - CEP remains valid|21/12/2023; New application|CEP granted|18/05/2022 |
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| 353 | Prednisolone, Process II | TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. Tianjin CN | 100011805;100018616 | CEP 2020-217 - Rev 01 | 2025/07/24 | Valid | Chemical | 2025/12/01 | Minor revision|Accepted - CEP remains valid|01/12/2025; Renewal|CEP granted|24/07/2025; New application|CEP granted|05/11/2020 |
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| 662 | Daunorubicin Hydrochloride | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2001-284 - Rev 04 | 2025/07/24 | Valid | Chemical | 2026/01/26 | Monograph revision|Accepted - CEP remains valid|26/01/2026; Notification|CEP granted|24/07/2025; Monograph revision|Accepted - CEP remains valid|17/02/2023; Minor revision|CEP granted|26/07/2022; Notification|CEP granted|20/12/2021; Notification|Accepted - CEP remains valid|26/06/2020 |
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| 2305 | Vigabatrin | SIONC PHARMACEUTICALS PVT. LTD. Visakhapatnam IN | 100014842;100023477 | CEP 2019-099 - Rev 01 | 2025/07/24 | Valid | 27/01/2027 | Chemical | 2025/07/24 | Minor revision|CEP granted|24/07/2025 | |
| 1756 | Lamotrigine | ARAGEN LIFE SCIENCES LIMITED Hyderabad IN | 100030840;100052317 | CEP 2010-249 - Rev 07 | 2025/07/24 | Valid | Chemical | 2025/07/24 | Minor revision|CEP granted|24/07/2025; Minor revision|CEP granted|27/11/2024; Notification|CEP granted|18/10/2023; Notification|CEP granted|24/05/2023; Minor revision|CEP granted|17/08/2022; Notification|CEP granted|22/02/2021 |
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| 1103 | Fentanyl citrate | SIEGFRIED GRAFTON INC. Grafton US | 100042515;100070251 | CEP 2005-081 - Rev 04 | 2025/07/22 | Valid | Chemical | 2025/07/22 | Notification|CEP granted|22/07/2025; Notification|CEP granted|27/08/2021 |
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| 1142 | Povidone, iodinated | BOAI NKY MEDICAL HOLDINGS LTD. Jiaozuo CN | 100051122;100089488 | CEP 2025-012 - Rev 00 | 2025/07/22 | Valid | 22/07/2030 | Chemical | 2025/07/22 | New application|CEP granted|22/07/2025 | |
| 2570 | Desloratadine, Milled, micronised | MOREPEN LABORATORIES LIMITED Baddi IN | 100017843;100026642 | CEP 2014-302 - Rev 01 | 2025/07/22 | Valid | Chemical | 2025/07/22 | Minor revision|CEP granted|22/07/2025; Minor revision|Accepted - CEP remains valid|31/01/2023; Minor revision|Accepted - CEP remains valid|02/07/2021; Renewal|CEP granted|19/10/2020; Minor revision|Accepted - CEP remains valid|24/02/2020 |
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| 829 | Hydralazine hydrochloride | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2018-287 - Rev 03 | 2025/07/22 | Valid | Chemical | 2025/07/22 | Renewal|CEP granted|22/07/2025; Minor revision|CEP granted|20/03/2024; Minor revision|Accepted - CEP remains valid|29/06/2023; Monograph revision|CEP granted|24/05/2022; Minor revision|Accepted - CEP remains valid|22/01/2021 |
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| 525 | Propylthiouracil | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | CEP 2015-125 - Rev 02 | 2025/07/22 | Valid | Chemical | 2025/07/22 | Minor revision|CEP granted|22/07/2025; Notification|Accepted - CEP remains valid|26/11/2024; Monograph revision|CEP granted|02/10/2023; Notification|Accepted - CEP remains valid|13/05/2022; Renewal|CEP granted|01/02/2022; Minor revision|Accepted - CEP remains valid|16/04/2021 |
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| 2357 | Dydrogesterone, Micronized | YANGZHOU AURISCO PHARMACEUTICAL CO., LTD. Yangzhou City CN | 100048379;100080110 | CEP 2021-460 - Rev 03 | 2025/07/22 | Valid | 07/11/2027 | Chemical | 2025/07/22 | Minor revision|CEP granted|22/07/2025; Minor revision|CEP granted|06/09/2023; Minor revision|CEP granted|16/03/2023; New application|CEP granted|07/11/2022 |
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| . | Lab Lemco Powder | OXOID LIMITED Basingstoke GB | 100052176;100095427 | CEP 2024-283 - Rev 00 | 2025/07/22 | Valid | 22/07/2030 | TSE | 2025/07/22 | New application|CEP granted|22/07/2025 | |
| 1173 | Benserazide hydrochloride | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2022-200 - Rev 01 | 2025/07/22 | Valid | 06/02/2029 | Chemical | 2025/07/22 | Minor revision|CEP granted|22/07/2025; Minor revision|Accepted - CEP remains valid|13/09/2024; Notification|Accepted - CEP remains valid|26/03/2024; New application|CEP granted|06/02/2024 |
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| 766 | Flucytosine | DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH | 100053293;100094111 | CEP 2009-091 - Rev 02 | 2025/07/22 | Valid | Chemical | 2025/07/22 | Notification|CEP granted|22/07/2025; Minor revision|CEP granted|11/01/2022 |
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