| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 568 | Propranolol hydrochloride | MANKIND PHARMA LIMITED New Delhi IN | 100040218;100065486 | CEP 2021-104 - Rev 01 | 2025/06/20 | Valid | 30/08/2028 | Chemical | 2025/06/20 | Notification|CEP granted|20/06/2025; New application|CEP granted|30/08/2023 |
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| 3087 | Ticagrelor | MANKIND PHARMA LIMITED New Delhi IN | 100040218;100065486 | CEP 2022-067 - Rev 01 | 2025/06/20 | Valid | 06/07/2028 | Chemical | 2025/06/20 | Notification|CEP granted|20/06/2025; New application|CEP granted|06/07/2023 |
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| 101 | Nitrofurantoin, Macrocrystals (Process-II) | MANKIND PHARMA LIMITED New Delhi IN | 100040218;100065486 | CEP 2021-371 - Rev 01 | 2025/06/20 | Valid | 10/12/2026 | Chemical | 2025/06/20 | Notification|CEP granted|20/06/2025; New application|CEP granted|10/12/2021 |
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| 889 | Clomipramine Hydrochloride | MANKIND PHARMA LIMITED New Delhi IN | 100040218;100065486 | CEP 2020-310 - Rev 01 | 2025/06/20 | Valid | 24/10/2027 | Chemical | 2025/06/20 | Notification|CEP granted|20/06/2025; New application|CEP granted|24/10/2022 |
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| 687 | Salbutamol sulfate, Process III, Non-micronised and Micronised | CIPLA LIMITED Mumbai IN | 100006004;100018147 | CEP 2025-002 - Rev 00 | 2025/06/20 | Valid | 20/06/2030 | Chemical | 2025/06/20 | New application|CEP granted|20/06/2025 | |
| 560 | Methotrexate | RAVI BIOLIFE PRIVATE LTD. Mumbai IN | 100048404;100086771 | CEP 2024-257 - Rev 00 | 2025/06/20 | Valid | 20/06/2030 | Chemical | 2025/06/20 | New application|CEP granted|20/06/2025 | |
| 1466 | Prazepam | F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT | 100011866;100022277 | CEP 2023-291 - Rev 00 | 2025/06/20 | Valid | 20/06/2030 | Chemical | 2025/06/20 | New application|CEP granted|20/06/2025 | |
| 101 | Nitrofurantoin, Macrocrystals | ASOLUTION PHARMACEUTICALS PVT. LTD. Thane IN | 100043528;100072005 | CEP 2023-346 - Rev 00 | 2025/06/19 | Valid | 19/06/2030 | Chemical | 2025/06/19 | New application|CEP granted|19/06/2025 | |
| 1765 | Salmeterol xinafoate, Micronised, non-micronised | AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN | 100045727;100075371 | CEP 2008-239 - Rev 05 | 2025/06/19 | Valid | Chemical | 2025/06/19 | Minor revision|CEP granted|19/06/2025; Notification|CEP granted|14/10/2022; Notification|CEP granted|25/11/2021; Minor revision|CEP granted|15/07/2021 |
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| 2125 | Doxazosin mesilate | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100029297 | CEP 2023-154 - Rev 00 | 2025/06/19 | Valid | 19/06/2030 | Chemical | 2025/06/19 | New application|CEP granted|19/06/2025 | |
| 1188 | Cefixime, Process 2 | QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN | 100033695;100052910 | CEP 2021-361 - Rev 01 | 2025/06/19 | Valid | 09/12/2026 | Chemical | 2025/06/19 | Minor revision|CEP granted|19/06/2025; Major revision|Accepted - CEP remains valid|12/05/2022; New application|CEP granted|09/12/2021 |
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| 1248 | Norfloxacin | ZHEJIANG LEPU PHARMACEUTICAL CO., LTD Taizhou City CN | 100033518;100052465 | CEP 2006-037 - Rev 05 | 2025/06/19 | Valid | Chemical | 2025/06/19 | Minor revision|CEP granted|19/06/2025; Minor revision|Accepted - CEP remains valid|12/11/2024; Minor revision|CEP granted|20/02/2024; Notification|CEP granted|16/08/2021; Monograph revision|CEP granted|15/07/2021 |
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| 1653 | Potassium clavulanate, diluted, with silica, colloidal hydrated (0738) in ratio 1:1 | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD Datong CN | 100033465;100082197 | CEP 2014-329 - Rev 01 | 2025/06/18 | Valid | Chemical | 2025/06/18 | Minor revision|CEP granted|18/06/2025; Renewal|CEP granted|03/03/2021 |
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| 2858 | Mometasone furoate monohydrate, Micronised | CIPLA LIMITED Mumbai IN | 100006004;100018147 | CEP 2018-290 - Rev 02 | 2025/06/18 | Valid | Chemical | 2025/06/18 | Minor revision|CEP granted|18/06/2025; Renewal|CEP granted|23/01/2025 |
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| 1346 | Metamizole sodium monohydrate | HEBEI JIHENG PHARMACEUTICAL CO., LTD. Hengshui City CN | 100016565;100052147 | CEP 2005-143 - Rev 03 | 2025/06/18 | Valid | Chemical | 2025/06/18 | Minor revision|CEP granted|18/06/2025; Minor revision|CEP granted|03/03/2021 |
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| 2732 | Dienogest | STERLING S.p.A. Solomeo Di Corciano IT | 100024377;100033551 | CEP 2016-158 - Rev 01 | 2025/06/18 | Valid | Chemical | 2025/06/18 | Major revision|CEP granted|18/06/2025; Renewal|CEP granted|02/08/2023 |
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| 2762 | Capecitabine | SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN | 100044578;100073706 | CEP 2014-332 - Rev 03 | 2025/06/18 | Valid | Chemical | 2025/06/18 | Minor revision|CEP granted|18/06/2025; Notification|Accepted - CEP remains valid|26/10/2023; Minor revision|CEP granted|07/02/2023; Notification|CEP granted|20/07/2022; Renewal|CEP granted|30/09/2021; Minor revision|Accepted - CEP remains valid|30/07/2020 |
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| 464 | Amitriptyline hydrochloride | MANKIND PHARMA LIMITED New Delhi IN | 100040218;100065486 | CEP 2019-227 - Rev 01 | 2025/06/18 | Withdrawn by Holder | 2026/03/25 | Chemical | 2026/03/25 | ||
| 2856 | Pirfenidone | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2019-155 - Rev 02 | 2025/06/18 | Valid | Chemical | 2025/06/18 | Renewal|CEP granted|18/06/2025; Minor revision|CEP granted|16/11/2022 |
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| 2296 | Pantoprazole sodium sesquihydrate | MANKIND PHARMA LIMITED New Delhi IN | 100040218;100065486 | CEP 2021-073 - Rev 01 | 2025/06/18 | Valid | 14/11/2027 | Chemical | 2025/06/18 | Notification|CEP granted|18/06/2025; New application|CEP granted|14/11/2022 |
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