| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2931 | Sorafenib tosilate | BDR LIFESCIENCES PRIVATE LIMITED Luna Village IN | 100034093;100053921 | CEP 2022-478 - Rev 01 | 2025/06/23 | Valid | 06/11/2029 | Chemical | 2025/06/23 | Monograph revision|CEP granted|23/06/2025; New application|CEP granted|06/11/2024 |
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| 1647 | Lactobionic acid | GLOBAL CALCIUM PRIVATE LIMITED Hosur IN | 100020125;100028859 | CEP 2018-164 - Rev 01 | 2025/06/20 | Valid | Chemical | 2025/06/20 | Renewal|CEP granted|20/06/2025 | ||
| 1092 | Cyclizine Hydrochloride | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2010-355 - Rev 04 | 2025/06/20 | Valid | Chemical | 2025/06/20 | Minor revision|CEP granted|20/06/2025; Minor revision|Accepted - CEP remains valid|07/12/2020 |
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| 884 | Carbimazole | CURIA FRANCE S.A.S. Bon-Encontre FR | 100040782;100067084 | CEP 2019-078 - Rev 02 | 2025/06/20 | Valid | Chemical | 2025/06/20 | Renewal|CEP granted|20/06/2025; Minor revision|Accepted - CEP remains valid|25/04/2024; Minor revision|Accepted - CEP remains valid|28/04/2023; Minor revision|CEP granted|26/08/2021 |
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| 2244 | Tacrolimus monohydrate | BIOCON LIMITED Bengaluru IN | 100011487;100018595 | CEP 2017-257 - Rev 02 | 2025/06/20 | Valid | Chemical | 2025/06/20 | Minor revision|CEP granted|20/06/2025; Notification|Accepted - CEP remains valid|04/03/2024; Minor revision|CEP granted|29/11/2023; Renewal|CEP granted|15/03/2023; Major revision|CEP granted|12/12/2022; Major revision|Rejected|20/10/2022; Minor revision|Accepted - CEP remains valid|10/03/2022; Minor revision|Accepted - CEP remains valid|09/06/2021; Minor revision|CEP granted|23/09/2020 |
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| 1352 | Omega-3-acid triglycerides, Containing alpha tocopherol as antioxidant | BASF AS Oslo NO | 100003052;100032709 | CEP 2017-298 - Rev 05 | 2025/06/20 | Valid | Chemical | 2025/06/20 | Minor revision|CEP granted|20/06/2025; Renewal|CEP granted|21/08/2024; Notification|Accepted - CEP remains valid|25/07/2023; Monograph revision|Accepted - CEP remains valid|06/01/2021; Minor revision|CEP granted|18/05/2020; Notification|CEP granted|28/01/2020 |
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| 330 | Gelatin, Alkaline hide gelatin | SHANDONG HENGXIN BIOTECH CO., LTD. Binzhou City CN | 100054241;100096001 | CEP 2020-191 - Rev 01 | 2025/06/20 | Valid | TSE | 2025/06/20 | Renewal|CEP granted|20/06/2025; New application|CEP granted|30/11/2020 |
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| 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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