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 |
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1200 | Dobutamine hydrochloride | BIOINDUSTRIA L.I.M. S.P.A. Novi Ligure IT | 100001870;100092872 | CEP 2004-261 - Rev 02 | 2025/08/14 | Valid | Chemical | 2025/08/14 | Minor revision|CEP granted|14/08/2025 | ||
3132 | Mirabegron | BIOCON LIMITED Bengaluru IN | 100011487;100018595 | CEP 2023-460 - Rev 00 | 2025/08/14 | Valid | 14/08/2030 | Chemical | 2025/08/14 | New application|CEP granted|14/08/2025 | |
1983 | Josamycin | MICROBIOPHARM JAPAN CO., LTD. Tokyo JP | 100012325;100088928 | CEP 2021-502 - Rev 02 | 2025/08/14 | Valid | 29/06/2028 | Chemical | 2025/08/14 | Minor revision|CEP granted|14/08/2025; Minor revision|CEP granted|01/07/2024; New application|CEP granted|29/06/2023 |
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369 | Azathioprine | RPG LIFE SCIENCES LIMITED Navi Mumbai IN | 100017119;100025920 | CEP 2001-341 - Rev 11 | 2025/08/14 | Valid | Chemical | 2025/08/14 | Minor revision|CEP granted|14/08/2025; Notification|CEP granted|12/04/2024; Minor revision|CEP granted|14/03/2024; Minor revision|CEP granted|22/08/2022 |
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106 | Hyoscine hydrobromide | ALKALOIDS PRIVATE LIMITED Secunderabad IN | 100021602;100041426 | CEP 2019-152 - Rev 02 | 2025/08/14 | Valid | Chemical | 2025/08/14 | Renewal|CEP granted|14/08/2025; Transfer of holdership|CEP granted|11/12/2023 |
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931 | Metformin Hydrochloride, 2nd line | NINGXIA HENGKANG TECHNOLOGY CO., LTD. Yinchuan CN | 100049743;100086705 | CEP 2024-237 - Rev 02 | 2025/08/14 | Valid | 02/08/2029 | Chemical | 2025/08/14 | Major revision|CEP granted|14/08/2025; Minor revision|CEP granted|23/12/2024; New application|CEP granted|02/08/2024 |
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829 | Hydralazine hydrochloride | D. K. PHARMA CHEM PRIVATE LIMITED Badlapur IN | 100023552;100032697 | CEP 2023-431 - Rev 00 | 2025/08/14 | Valid | 14/08/2030 | Chemical | 2025/08/14 | New application|CEP granted|14/08/2025 | |
1084 | Cetirizine dihydrochloride | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2006-309 - Rev 02 | 2025/08/13 | Valid | Chemical | 2025/08/13 | Minor revision|CEP granted|13/08/2025; Notification|Accepted - CEP remains valid|23/06/2023 |
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1519 | Flurbiprofen, Process 3 | FDC Limited Mumbai IN | 100011646;100021030 | CEP 2025-225 - Rev 00 | 2025/08/13 | Valid | 13/08/2030 | Chemical | 2025/08/13 | New application|CEP granted|13/08/2025 | |
1764 | Rocuronium bromide | MANKIND PHARMA LIMITED New Delhi IN | 100040218;100065486 | CEP 2024-337 - Rev 00 | 2025/08/13 | Valid | 13/08/2030 | Chemical | 2025/08/13 | New application|CEP granted|13/08/2025 | |
199 | Oxytetracycline dihydrate | INNER MONGOLIA HUASHU BIOLOGICAL TECHNOLOGY CO.LTD Tongliao City CN | 100052898;100093261 | CEP 2018-238 - Rev 01 | 2025/08/13 | Valid | Chemical | 2025/08/13 | Renewal|CEP granted|13/08/2025 | ||
1450 | Mupirocin, Process B | FUJIAN COMHONY BIOTECHNOLOGY CO., LTD. Fuqing CN | 100043888;100072481 | CEP 2022-391 - Rev 01 | 2025/08/13 | Valid | 29/11/2028 | Chemical and TSE | 2025/08/13 | Minor revision|CEP granted|13/08/2025; New application|CEP granted|29/11/2023 |
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2223 | Glimepiride | MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN | 100018316;100070723 | CEP 2022-111 - Rev 01 | 2025/08/12 | Valid | 05/07/2029 | Chemical | 2025/08/12 | Minor revision|CEP granted|12/08/2025; New application|CEP granted|05/07/2024 |
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1705 | Sertraline hydrochloride, Process IVB | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2017-264 - Rev 01 | 2025/08/12 | Valid | Chemical | 2025/08/12 | Minor revision|CEP granted|12/08/2025; Renewal|CEP granted|05/05/2023; Minor revision|Accepted - CEP remains valid|07/06/2022; Minor revision|Accepted - CEP remains valid|24/02/2022; Administrative procedure|CEP granted|10/11/2021; Major revision|CEP granted|25/10/2021; Notification|CEP granted|30/03/2021; Minor revision|Accepted - CEP remains valid|05/03/2021; Notification|Accepted - CEP remains valid|02/12/2020; Notification|Accepted - CEP remains valid|24/04/2020 |
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1058 | Vancomycin hydrochloride, Precipitated | LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN | 100020920;100029633 | CEP 2012-235 - Rev 04 | 2025/08/12 | Valid | Chemical | 2025/08/12 | Administrative procedure|CEP granted|12/08/2025; Minor revision|CEP granted|25/07/2025; Monograph revision|CEP granted|28/10/2024; Notification|Accepted - CEP remains valid|06/06/2024; Minor revision|CEP granted|31/03/2023; Minor revision|Rejected|13/01/2023; Notification|Accepted - CEP remains valid|27/05/2021 |
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2778 | Sitagliptin phosphate monohydrate, Process II | ZHEJIANG JINGSHENG PHARMACEUTICAL CO., LTD. Taizhou City CN | 100048181;100079705 | CEP 2023-453 - Rev 01 | 2025/08/12 | Valid | 06/05/2029 | Chemical | 2025/08/12 | Transfer of holdership|CEP granted|12/08/2025; New application|CEP granted|06/05/2024 |
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2423 | Valsartan | NINGBO MENOVO PHARMACEUTICAL CO., LTD. Ningbo CN | 100030313;100047776 | CEP 2019-258 - Rev 02 | 2025/08/12 | Valid | 05/02/2026 | Chemical | 2025/08/12 | Minor revision|CEP granted|12/08/2025; Major revision|CEP granted|09/07/2024; Minor revision|Accepted - CEP remains valid|13/10/2022; Notification|Accepted - CEP remains valid|01/12/2021; Minor revision|Accepted - CEP remains valid|25/06/2021 |
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1734 | Terbinafine hydrochloride | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2007-146 - Rev 08 | 2025/08/11 | Valid | Chemical | 2025/08/11 | Minor revision|CEP granted|11/08/2025; Minor revision|Accepted - CEP remains valid|21/06/2024; Notification|CEP granted|05/03/2024; Notification|CEP granted|13/12/2023; Notification|Accepted - CEP remains valid|20/12/2022; Minor revision|CEP granted|14/08/2020 |
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721 | Ibuprofen | HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO., LTD. Jingmen City CN | 100020377;100029131 | CEP 2002-099 - Rev 08 | 2025/08/11 | Valid | Chemical | 2025/08/11 | Minor revision|CEP granted|11/08/2025; Minor revision|Accepted - CEP remains valid|04/05/2023; Notification|CEP granted|07/12/2020; Notification|CEP granted|07/08/2020 |
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2338 | Mirtazapine | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2007-062 - Rev 05 | 2025/08/11 | Valid | Chemical | 2025/08/11 | Minor revision|CEP granted|11/08/2025; Notification|CEP granted|13/12/2023; Minor revision|Accepted - CEP remains valid|20/02/2020 |