| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 752 | Alanine | EVONIK REXIM (NANNING) PHARMACEUTICAL CO., LTD. Nanning CN | R1-CEP 2004-086 - Rev 07 | 2023/08/24 | Valid | Chemical | 2023/12/04 | Notification|Accepted - CEP remains valid|04/12/2023; Notification|CEP granted|24/08/2023; Minor revision|Accepted - CEP remains valid|09/06/2021; Notification|Abandoned|18/01/2021 |
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| 1027 | Methionine | EVONIK REXIM (NANNING) PHARMACEUTICAL CO., LTD. Nanning CN | R1-CEP 2005-190 - Rev 04 | 2023/08/24 | Valid | Chemical | 2023/08/24 | Notification|CEP granted|24/08/2023; Notification|Accepted - CEP remains valid|21/02/2022 |
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| 624 | DL-Methionine | EVONIK REXIM (NANNING) PHARMACEUTICAL CO., LTD. Nanning CN | R1-CEP 2006-139 - Rev 06 | 2023/08/24 | Valid | Chemical | 2023/08/24 | Notification|CEP granted|24/08/2023; Notification|CEP granted|26/04/2022; Minor revision|CEP granted|26/11/2020 |
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| 796 | Valine | EVONIK REXIM (NANNING) PHARMACEUTICAL CO., LTD. Nanning CN | R1-CEP 2008-128 - Rev 03 | 2023/08/24 | Valid | Chemical | 2024/01/02 | Notification|Accepted - CEP remains valid|02/01/2024; Notification|CEP granted|24/08/2023; Minor revision|Accepted - CEP remains valid|20/07/2022 |
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| 711 | Cyclophosphamide monohydrate | EMCURE PHARMACEUTICALS LIMITED Pune IN | R1-CEP 2010-329 - Rev 02 | 2023/08/24 | Valid | Chemical | 2023/08/24 | Monograph revision|CEP granted|24/08/2023; Minor revision|CEP granted|18/11/2020 |
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| 788 | Serine, Wuming site | EVONIK REXIM (NANNING) PHARMACEUTICAL CO., LTD. Nanning CN | R1-CEP 2014-366 - Rev 01 | 2023/08/24 | Valid | Chemical | 2023/08/24 | Notification|CEP granted|24/08/2023; Minor revision|Accepted - CEP remains valid|02/03/2023; Notification|Rejected|25/11/2022 |
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| 2606 | Tadalafil | RUYUAN HEC PHARM CO., LTD. Shaoguan CN | R1-CEP 2018-005 - Rev 00 | 2023/08/24 | Valid | Chemical | 2023/08/24 | Renewal|CEP granted|24/08/2023 | |||
| 711 | Cyclophosphamide monohydrate | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | R0-CEP 2018-092 - Rev 01 | 2023/08/23 | Valid | 31/10/2024 | Chemical | 2023/08/23 | Monograph revision|CEP granted|23/08/2023 | ||
| 923 | Labetalol Hydrochloride | SRINI PHARMACEUTICALS PRIVATE LIMITED Choutuppal IN | R0-CEP 2021-241 - Rev 00 | 2023/08/23 | Valid | 23/08/2028 | Chemical | 2023/08/23 | New application|CEP granted|23/08/2023 | ||
| 288 | Pyrimethamine | Interquim S.A. DE C.V. Estado De Mexico MX | R0-CEP 2022-045 - Rev 00 | 2023/08/23 | Valid | 23/08/2028 | Chemical | 2023/08/23 | New application|CEP granted|23/08/2023 | ||
| 810 | Betamethasone sodium phosphate, Process II | CURIA SPAIN S.A.U. Boecillo ES | R0-CEP 2023-167 - Rev 00 | 2023/08/23 | Valid | 23/08/2028 | Chemical and TSE | 2023/08/23 | New application|CEP granted|23/08/2023 | ||
| 1489 | Ambroxol hydrochloride, Process II | AMI LIFESCIENCES PRIVATE LIMITED Karakhadi IN | R0-CEP 2023-168 - Rev 00 | 2023/08/23 | Valid | 23/08/2028 | Chemical | 2023/08/23 | New application|CEP granted|23/08/2023 | ||
| 2372 | Esomeprazole magnesium trihydrate, Powder | JUBILANT PHARMOVA LIMITED Nanjangud IN | R0-CEP 2023-175 - Rev 01 | 2023/08/23 | Valid | 18/08/2028 | Chemical | 2023/08/23 | Administrative procedure|CEP granted|23/08/2023; New application|CEP granted|18/08/2023 |
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| 1181 | Buprenorphine hydrochloride | NORAMCO, LLC. Wilmington US | R1-CEP 2010-142 - Rev 05 | 2023/08/23 | Valid | Chemical | 2023/08/23 | Notification|CEP granted|23/08/2023; Minor revision|Accepted - CEP remains valid|01/06/2022; Minor revision|Accepted - CEP remains valid|14/03/2022; Notification|CEP granted|27/01/2020 |
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| 1783 | Glycopyrronium bromide | OLON S.P.A. Rodano IT | R1-CEP 2013-110 - Rev 04 | 2023/08/23 | Valid | Chemical | 2023/08/23 | Minor revision|CEP granted|23/08/2023; Major revision|CEP granted|25/07/2022; Minor revision|CEP granted|02/10/2020 |
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| 2598 | Levofloxacin hemihydrate | MSN LIFE SCIENCES PRIVATE LIMITED Chandampet Village IN | R0-CEP 2021-016 - Rev 00 | 2023/08/22 | Valid | 22/08/2028 | Chemical | 2023/08/22 | New application|CEP granted|22/08/2023 | ||
| 1734 | Terbinafine hydrochloride, Type 2 | OLON S.P.A. Rodano IT | R0-CEP 2021-256 - Rev 01 | 2023/08/22 | Valid | 07/02/2027 | Chemical | 2023/08/22 | Minor revision|CEP granted|22/08/2023; New application|CEP granted|07/02/2022 |
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| 303 | Thiamine hydrochloride | HUAZHONG PHARMACEUTICAL CO., LTD. Xiangyang CN | R0-CEP 2021-441 - Rev 00 | 2023/08/22 | Valid | 22/08/2028 | Chemical | 2023/08/22 | New application|CEP granted|22/08/2023 | ||
| 335 | Hydrocortisone | HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN | R0-CEP 2022-264 - Rev 00 | 2023/08/22 | Valid | 22/08/2028 | Chemical | 2023/08/22 | New application|CEP granted|22/08/2023 | ||
| . | Foetal Bovine Serum | SERADIGM/VWR INTERNATIONAL Radnor US | R1-CEP 2014-065 - Rev 02 | 2023/08/22 | Valid | TSE | 2023/08/22 | Major revision|CEP granted|22/08/2023; Minor revision|CEP granted|20/01/2023; Renewal|CEP granted|02/07/2020 |
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