| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 203 | Polymyxin B sulfate | North China Pharmaceutical Huasheng Co., Ltd. Shijiazhuang CN | 100021261;100029965 | CEP 2024-323 - Rev 00 | 2025/07/11 | Valid | 11/07/2030 | Chemical | 2025/07/11 | New application|CEP granted|11/07/2025 | |
| 1182 | Calcium ascorbate dihydrate | DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH | 100053293;100094111 | CEP 2002-253 - Rev 02 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Minor revision|CEP granted|19/03/2024; Monograph revision|Accepted - CEP remains valid|03/08/2023 |
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| 1069 | Betacarotene | DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH | 100053293;100094111 | CEP 2010-383 - Rev 02 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025 | ||
| 1559 | Risperidone | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2003-110 - Rev 06 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Minor revision|CEP granted|02/05/2023; Notification|CEP granted|23/02/2022; Minor revision|CEP granted|03/09/2020 |
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| 1046 | Tamoxifen citrate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 1999-180 - Rev 07 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Notification|CEP granted|21/12/2021; Notification|CEP granted|07/12/2020 |
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| 761 | Dexpanthenol | DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH | 100053293;100094111 | CEP 1997-113 - Rev 04 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Monograph revision|CEP granted|22/04/2021 |
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| 543 | Carbamazepine | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2000-164 - Rev 06 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Notification|CEP granted|21/12/2021 |
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| 1745 | Carvedilol | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2003-048 - Rev 07 | 2025/07/11 | Valid | Chemical | 2025/12/11 | Notification|Accepted - CEP remains valid|11/12/2025; Notification|CEP granted|11/07/2025; Notification|CEP granted|23/02/2022; Notification|CEP granted|19/10/2020 |
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| 574 | Cholecalciferol concentrate (powder form), 100 000 IU/g, with all-rac-α-tocopherol | DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH | 100053293;100094111 | CEP 2015-199 - Rev 01 | 2025/07/11 | Valid | Chemical and TSE | 2025/11/27 | Notification|Accepted - CEP remains valid|27/11/2025; Notification|CEP granted|11/07/2025; Renewal|CEP granted|03/09/2021; Minor revision|CEP granted|13/08/2020 |
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| 1559 | Risperidone | AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100046306;100076393 | CEP 2024-147 - Rev 00 | 2025/07/11 | Valid | 11/07/2030 | Chemical | 2025/07/11 | New application|CEP granted|11/07/2025 | |
| 253 | Ascorbic acid | HEILONGJIANG NHU BIOTECHNOLOGY CO. LTD Suihua City CN | 100047549;100078532 | CEP 2023-349 - Rev 01 | 2025/07/10 | Valid | 19/11/2029 | Chemical | 2025/07/10 | Minor revision|CEP granted|10/07/2025; New application|CEP granted|19/11/2024 |
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| 2780 | Temozolomide | FORMOSA LABORATORIES, INC. Taoyuan TW | 100011879;100018688 | CEP 2017-245 - Rev 02 | 2025/07/09 | Valid | Chemical | 2025/07/09 | Notification|CEP granted|09/07/2025; Renewal|CEP granted|26/04/2024; Notification|Accepted - CEP remains valid|07/07/2022 |
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| 1004 | Diltiazem hydrochloride | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 1997-077 - Rev 16 | 2025/07/09 | Valid | Chemical | 2025/09/16 | Notification|Accepted - CEP remains valid|16/09/2025; Minor revision|CEP granted|09/07/2025; Notification|CEP granted|12/03/2025; Notification|Accepted - CEP remains valid|10/10/2024; Minor revision|CEP granted|13/12/2021; Minor revision|CEP granted|25/09/2020 |
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| 1472 | Sodium hyaluronate, Intrinsic viscosity 2.93 m3/kg, by fermentation, for parenteral administration including intra-articular administration and for intra-ocular use | KEWPIE CORP. Tokyo JP | 100039277;100093553 | CEP 2019-064 - Rev 01 | 2025/07/09 | Valid | Chemical and TSE | 2025/07/09 | Renewal|CEP granted|09/07/2025; Minor revision|Accepted - CEP remains valid|01/12/2020 |
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| 2330 | Leflunomide | FORMOSA LABORATORIES, INC. Taoyuan TW | 100011879;100018688 | CEP 2009-035 - Rev 03 | 2025/07/09 | Valid | Chemical | 2025/07/09 | Notification|CEP granted|09/07/2025; Minor revision|CEP granted|12/05/2025 |
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| 734 | Prednisolone acetate, Micronised, sterile, alternative process | FARMABIOS S.p.A Gropello Cairoli IT | 100011643;100021232 | CEP 2024-549 - Rev 00 | 2025/07/09 | Valid | 09/07/2030 | Chemical | 2025/07/09 | New application|CEP granted|09/07/2025 | |
| 3132 | Mirabegron, α-Form | MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN | 100011732;100018657 | CEP 2024-031 - Rev 00 | 2025/07/09 | Valid | 09/07/2030 | Chemical | 2025/07/09 | New application|CEP granted|09/07/2025 | |
| 2591 | Celecoxib | AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100046306;100076393 | CEP 2019-112 - Rev 01 | 2025/07/09 | Valid | Chemical | 2026/01/07 | Renewal|Accepted - CEP remains valid|07/01/2026; Minor revision|CEP granted|09/07/2025 |
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| 2640 | Atomoxetine hydrochloride, Process 2 | COHANCE LIFESCIENCES LIMITED Mumbai IN | 100011755;100090273 | CEP 2019-212 - Rev 03 | 2025/07/09 | Valid | Chemical | 2025/07/09 | Renewal|CEP granted|09/07/2025; Notification|CEP granted|10/07/2024; Notification|CEP granted|12/02/2021 |
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| 929 | Loperamide hydrochloride | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2008-313 - Rev 04 | 2025/07/08 | Valid | Chemical | 2025/07/08 | Notification|CEP granted|08/07/2025; Minor revision|Accepted - CEP remains valid|19/06/2024; Minor revision|Accepted - CEP remains valid|08/08/2022; Notification|CEP granted|04/01/2022; Notification|Accepted - CEP remains valid|02/02/2021 |
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