| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 412 | Sodium citrate dihydrate | JUNGBUNZLAUER LADENBURG GMBH Ladenburg DE | 100014785;100073136 | CEP 2018-273 - Rev 06 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Renewal|CEP granted|21/10/2024; Notification|CEP granted|21/06/2024; Notification|Accepted - CEP remains valid|24/08/2023; Minor revision|CEP granted|01/09/2022; Minor revision|CEP granted|09/06/2021; Minor revision|CEP granted|04/06/2020 |
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| 1520 | Foscarnet sodium hexahydrate | LIANYUNGANG RUNZHONG PHARMACEUTICAL CO., LTD. Lianyungang CN | 100019457;100028232 | CEP 2017-137 - Rev 01 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Minor revision|CEP granted|11/07/2025; Notification|Accepted - CEP remains valid|24/06/2024; Renewal|CEP granted|27/07/2023; Minor revision|Accepted - CEP remains valid|08/03/2022; Notification|Accepted - CEP remains valid|11/01/2022; Minor revision|Accepted - CEP remains valid|23/11/2020 |
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| 2931 | Sorafenib tosilate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2021-247 - Rev 02 | 2025/07/11 | Valid | 10/07/2028 | Chemical | 2025/07/11 | Monograph revision|CEP granted|11/07/2025; Minor revision|CEP granted|23/04/2024; New application|CEP granted|10/07/2023 |
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| 883 | Calcitriol, Process 2 (F007V1) | FORMOSA LABORATORIES, INC. Taoyuan TW | 100011879;100018688 | CEP 2020-150 - Rev 03 | 2025/07/11 | Valid | 22/10/2026 | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Monograph revision|CEP granted|18/12/2024; Administrative procedure|CEP granted|18/11/2021; New application|CEP granted|22/10/2021 |
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| 1472 | Sodium hyaluronate, GS-200; intrinsic viscosity 2.77 m3/kg; from fermentation; for parenteral administration, including intra-ocular use | KIKKOMAN BIOCHEMIFA CO. Noda City JP | 100039417;100087689 | CEP 2020-138 - Rev 01 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Renewal|CEP granted|11/07/2025; Notification|Accepted - CEP remains valid|03/05/2024; New application|CEP granted|28/08/2020 |
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| 72 | Cholecalciferol, Site Sisseln | DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH | 100053293;100094111 | CEP 2019-351 - Rev 02 | 2025/07/11 | Valid | Chemical and TSE | 2025/11/26 | Notification|Accepted - CEP remains valid|26/11/2025; Notification|CEP granted|11/07/2025; Renewal|CEP granted|14/03/2025 |
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| 2777 | Pregabalin | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2020-024 - Rev 03 | 2025/07/11 | Valid | 03/02/2027 | Chemical | 2025/07/11 | Minor revision|CEP granted|11/07/2025; Minor revision|CEP granted|19/06/2024; Major revision|CEP granted|16/09/2022; New application|CEP granted|03/02/2022 |
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| 2631 | Rosuvastatin calcium | CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. Delft NL | 100002351;100005259 | CEP 2015-090 - Rev 02 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Minor revision|CEP granted|11/07/2025; Minor revision|Accepted - CEP remains valid|21/12/2023; Minor revision|Accepted - CEP remains valid|02/05/2023; Minor revision|CEP granted|20/04/2022; Minor revision|Rejected|02/03/2022; Renewal|CEP granted|01/07/2021; Monograph revision|Accepted - CEP remains valid|27/05/2020 |
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| 2759 | Benzydamine hydrochloride | BAL PHARMA LIMITED Bengaluru IN | 100016398;100041736 | CEP 2021-325 - Rev 02 | 2025/07/11 | Valid | 12/04/2029 | Chemical | 2025/07/11 | Minor revision|CEP granted|11/07/2025; Administrative procedure|CEP granted|05/06/2024; New application|CEP granted|12/04/2024 |
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| 2594 | Duloxetine hydrochloride, Process-K | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2024-273 - Rev 01 | 2025/07/11 | Valid | 22/10/2029 | Chemical | 2025/07/11 | Minor revision|CEP granted|11/07/2025; New application|CEP granted|22/10/2024 |
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| 2288 | Citalopram hydrobromide | CIPLA LIMITED Mumbai IN | 100006004;100018147 | CEP 2009-012 - Rev 02 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Minor revision|CEP granted|11/07/2025 | ||
| 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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