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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22 | Diazepam | R L FINE CHEM PVT. LTD. Gowribidanur IN | R0-CEP 2019-264 - Rev 02 | 2023/08/16 | Valid | 07/12/2026 | Chemical | 2023/08/16 | Minor revision|CEP granted|16/08/2023; Minor revision|CEP granted|20/04/2022 |
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2637 | Pemetrexed disodium heptahydrate | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | R0-CEP 2020-336 - Rev 01 | 2023/08/16 | Valid | 09/12/2027 | Chemical | 2023/08/16 | Notification|CEP granted|16/08/2023; Monograph revision|Accepted - CEP remains valid|18/07/2023; New application|CEP granted|09/12/2022 |
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1115 | Iopamidol, Process 2 | ZHEJIANG STARRY PHARMACEUTICAL CO., LTD. Xianju CN | R0-CEP 2022-050 - Rev 01 | 2023/08/16 | Valid | 28/07/2028 | Chemical | 2023/08/16 | Administrative procedure|CEP granted|16/08/2023; New application|CEP granted|28/07/2023 |
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2154 | Telmisartan | ZHUHAI RUNDU PHARMACEUTICAL CO., LTD. Sanzao Town CN | R0-CEP 2022-179 - Rev 00 | 2023/08/16 | Valid | 16/08/2028 | Chemical | 2023/08/16 | New application|CEP granted|16/08/2023 | ||
2591 | Celecoxib, Site Khazipally | AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | R0-CEP 2023-194 - Rev 00 | 2023/08/16 | Valid | 16/08/2028 | Chemical | 2023/08/16 | New application|CEP granted|16/08/2023 | ||
2762 | Capecitabine | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | R1-CEP 2015-391 - Rev 02 | 2023/08/16 | Valid | Chemical | 2023/08/16 | Notification|CEP granted|16/08/2023; Minor revision|CEP granted|07/03/2023; Renewal|CEP granted|20/12/2021; Minor revision|CEP granted|06/01/2021 |
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2779 | Solifenacin succinate | CIPLA LIMITED Mumbai IN | R1-CEP 2017-062 - Rev 00 | 2023/08/16 | Valid | Chemical | 2023/08/16 | Renewal|CEP granted|16/08/2023; Notification|Accepted - CEP remains valid|26/04/2022 |
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2988 | Fingolimod hydrochloride | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | R0-CEP 2019-290 - Rev 01 | 2023/08/11 | Valid | 27/09/2026 | Chemical | 2024/04/23 | Monograph revision|Accepted - CEP remains valid|23/04/2024; Notification|CEP granted|11/08/2023; Minor revision|Accepted - CEP remains valid|20/01/2023 |
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2778 | Sitagliptin phosphate monohydrate | BIOCON LIMITED Bengaluru IN | R0-CEP 2020-197 - Rev 00 | 2023/08/11 | Valid | 11/08/2028 | Chemical | 2023/08/11 | New application|CEP granted|11/08/2023 | ||
2988 | Fingolimod hydrochloride, Form-I | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | R0-CEP 2021-066 - Rev 01 | 2023/08/11 | Valid | 13/03/2028 | Chemical | 2023/08/11 | Notification|CEP granted|11/08/2023; New application|CEP granted|13/03/2023 |
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576 | Allopurinol | HETERO DRUGS LIMITED Hyderabad IN | R0-CEP 2021-074 - Rev 01 | 2023/08/11 | Valid | 08/03/2028 | Chemical | 2023/08/11 | 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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2174 | Cladribine | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | R0-CEP 2021-217 - Rev 01 | 2023/08/11 | Valid | 25/05/2028 | Chemical | 2023/08/11 | Notification|CEP granted|11/08/2023; New application|CEP granted|26/05/2023 |
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1563 | Simvastatin, with 0.2% butylated hydroxy anisole | KREBS BIOCHEMICALS & INDUSTRIES LIMITED Kothapalli IN | R1-CEP 2007-210 - Rev 02 | 2023/08/11 | Valid | Chemical | 2023/08/11 | Minor revision|CEP granted|11/08/2023 | |||
2570 | Desloratadine | ROLABO OUTSOURCING, S.L. Zaragoza ES | R1-CEP 2017-303 - Rev 00 | 2023/08/11 | Valid | Chemical | 2023/08/11 | Renewal|CEP granted|11/08/2023 | |||
248 | Suxamethonium Chloride | TAKEDA GMBH Konstanz DE | R2-CEP 1995-021 - Rev 10 | 2023/08/11 | Valid | Chemical | 2023/08/11 | Notification|CEP granted|11/08/2023; Major revision|CEP granted|18/03/2022; Notification|CEP granted|21/04/2020 |
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2910 | Trifluridine | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | R0-CEP 2021-202 - Rev 01 | 2023/08/10 | Valid | 15/02/2028 | Chemical | 2023/08/10 | Notification|CEP granted|10/08/2023; New application|CEP granted|15/02/2023 |
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67 | Folic acid hydrate | DSM Nutritional Products Ltd. Kaiseraugst CH | R1-CEP 1996-045 - Rev 06 | 2023/08/10 | Valid | Chemical | 2023/08/10 | Administrative procedure|CEP granted|10/08/2023; Minor revision|CEP granted|06/07/2023; Monograph revision|Accepted - CEP remains valid|11/05/2022; Minor revision|CEP granted|27/04/2021 |
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1314 | Dosulepin hydrochloride | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | R1-CEP 2003-157 - Rev 05 | 2023/08/10 | Valid | Chemical | 2023/08/10 | Minor revision|CEP granted|10/08/2023 | |||
890 | Clonazepam | LAKE CHEMICALS PRIVATE LIMITED Bengaluru IN | R1-CEP 2009-101 - Rev 01 | 2023/08/10 | Valid | Chemical | 2023/08/10 | Minor revision|CEP granted|10/08/2023 | |||
2196 | Bicalutamide | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | R1-CEP 2012-283 - Rev 01 | 2023/08/10 | Valid | Chemical | 2023/08/10 | Notification|CEP granted|10/08/2023 |