| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2375 | Raloxifene hydrochloride | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100000217 | R1-CEP 2014-054 - Rev 01 | 2023/03/31 | Valid | Chemical | 2023/03/31 | Major revision|CEP granted|31/03/2023; Renewal|CEP granted|30/09/2020 |
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| 712 | Desmopressin | AURO PEPTIDES LIMITED Kandi Mandal IN | 100049810;100086899 | R1-CEP 2016-125 - Rev 01 | 2023/03/31 | Valid | Chemical | 2023/03/31 | Administrative procedure|CEP granted|31/03/2023; Renewal|CEP granted|20/02/2023 |
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| 925 | Levomepromazine maleate, Process 2 | EGIS Pharmaceuticals PLC Budapest HU | 100001091;100001662 | R1-CEP 2016-215 - Rev 01 | 2023/03/31 | Valid | Chemical | 2023/11/10 | Minor revision|Accepted - CEP remains valid|10/11/2023; Monograph revision|CEP granted|31/03/2023; Minor revision|Accepted - CEP remains valid|21/06/2022; Renewal|CEP granted|27/10/2021 |
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| 2779 | Solifenacin succinate | Unichem Laboratories Limited Mumbai IN | 100005397;100000756 | R1-CEP 2017-083 - Rev 00 | 2023/03/31 | Valid | Chemical | 2023/03/31 | Renewal|CEP granted|31/03/2023; Minor revision|Accepted - CEP remains valid|30/04/2020 |
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| 2244 | Tacrolimus monohydrate | Chunghwa Chemical Synthesis & Biotech Co., Ltd. Shu-Lin TW | 100011999;100018609 | R0-CEP 2018-241 - Rev 01 | 2023/03/30 | Valid | 03/02/2025 | Chemical | 2023/03/30 | Minor revision|CEP granted|30/03/2023; Notification|Accepted - CEP remains valid|02/11/2020 |
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| 2933 | Deferasirox | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | R0-CEP 2021-170 - Rev 02 | 2023/03/30 | Valid | 30/01/2028 | Chemical | 2023/03/30 | Minor revision|CEP granted|30/03/2023; Minor revision|Accepted - CEP remains valid|27/02/2023; Administrative procedure|CEP granted|08/02/2023; New application|CEP granted|30/01/2023 |
|
| 1208 | Fenbendazole for veterinary use, Process-II | SEQUENT SCIENTIFIC LIMITED Thane IN | 100017805;100032372 | R0-CEP 2021-357 - Rev 01 | 2023/03/30 | Withdrawn by Holder | 2024/05/14 | Chemical | 2023/03/30 | ||
| 1208 | Fenbendazole for veterinary use | SEQUENT SCIENTIFIC LIMITED Thane IN | 100017805;100032372 | R1-CEP 2004-212 - Rev 04 | 2023/03/30 | Valid | Chemical | 2023/03/30 | Notification|CEP granted|30/03/2023; Minor revision|Rejected|30/07/2021 |
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| 855 | Praziquantel | SEQUENT SCIENTIFIC LIMITED Thane IN | 100017805;100032372 | R1-CEP 2012-159 - Rev 05 | 2023/03/30 | Valid | Chemical | 2023/03/30 | Notification|CEP granted|30/03/2023; Minor revision|CEP granted|16/03/2022; Administrative procedure|CEP granted|30/08/2021; Minor revision|CEP granted|16/08/2021; Minor revision|CEP granted|03/06/2020 |
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| 1696 | Flunixin meglumine for veterinary use | SEQUENT SCIENTIFIC LIMITED Thane IN | 100017805;100032372 | R1-CEP 2013-017 - Rev 04 | 2023/03/30 | Valid | Chemical | 2024/05/03 | Minor revision|Accepted - CEP remains valid|03/05/2024; Notification|CEP granted|30/03/2023; Minor revision|CEP granted|16/09/2022; Minor revision|Accepted - CEP remains valid|02/06/2021; Minor revision|CEP granted|09/10/2020 |
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| 2531 | Clopidogrel hydrogen sulfate, Form II | TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL | 100000702;100060842 | R1-CEP 2017-260 - Rev 00 | 2023/03/30 | Valid | Chemical | 2023/03/30 | Renewal|CEP granted|30/03/2023; Minor revision|CEP granted|27/07/2022; Notification|CEP granted|24/02/2022; Minor revision|CEP granted|26/03/2020 |
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| 3014 | Rotigotine | NEULAND LABORATORIES LIMITED Hyderabad IN | 100011545;100062134 | R0-CEP 2020-010 - Rev 03 | 2023/03/29 | Valid | 25/05/2026 | Chemical | 2023/03/29 | Notification|CEP granted|29/03/2023; Minor revision|CEP granted|27/04/2022; Notification|CEP granted|08/09/2021; New application|CEP granted|25/05/2021 |
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| 3040 | Prasugrel hydrochloride | MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN | 100011732;100018657 | R0-CEP 2021-024 - Rev 00 | 2023/03/29 | Valid | 29/03/2028 | Chemical | 2023/03/29 | New application|CEP granted|29/03/2023 | |
| 2896 | Thiocolchicoside crystallised from ethanol, Indena India site | INDENA S.P.A. Milano IT | 100006081;100011479 | R1-CEP 2016-055 - Rev 01 | 2023/03/29 | Valid | Chemical | 2023/03/29 | Minor revision|CEP granted|29/03/2023; Renewal|CEP granted|19/10/2022; Notification|CEP granted|22/04/2021 |
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| 2136 | Ritonavir | LAURUS LABS LIMITED Hyderabad IN | 100011702;100032608 | R0-CEP 2020-102 - Rev 01 | 2023/03/28 | Valid | 23/06/2027 | Chemical | 2023/03/28 | Minor revision|CEP granted|28/03/2023; New application|CEP granted|23/06/2022 |
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| 2191 | Atorvastatin calcium | LAURUS LABS LIMITED Hyderabad IN | 100011702;100032608 | R0-CEP 2021-150 - Rev 01 | 2023/03/28 | Valid | 18/01/2028 | Chemical | 2023/03/28 | Administrative procedure|CEP granted|28/03/2023; New application|CEP granted|19/01/2023 |
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| 2119 | Venlafaxine hydrochloride | AMI LIFESCIENCES PRIVATE LIMITED Karakhadi IN | 100021822;100030527 | R0-CEP 2021-353 - Rev 00 | 2023/03/28 | Valid | 28/03/2028 | Chemical | 2023/03/28 | New application|CEP granted|28/03/2023 | |
| . | Newborn Bovine Calf Serum | CYTIVA Tauranga NZ | R1-CEP 2001-190 - Rev 06 | 2023/03/28 | Valid | TSE | 2023/03/28 | Major revision|CEP granted|28/03/2023; Major revision|CEP granted|22/02/2023; Notification|Accepted - CEP remains valid|03/03/2022; Notification|CEP granted|05/06/2020 |
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| 2307 | Modafinil | TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL | 100000702 | R1-CEP 2009-331 - Rev 04 | 2023/03/28 | Valid | Chemical | 2023/03/28 | Minor revision|CEP granted|28/03/2023; Notification|CEP granted|21/12/2021; Notification|Accepted - CEP remains valid|15/07/2021; Minor revision|CEP granted|26/05/2020 |
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| 2576 | Voriconazole | NEULAND LABORATORIES LIMITED Hyderabad IN | 100011545;100062134 | R1-CEP 2013-203 - Rev 02 | 2023/03/28 | Valid | Chemical | 2023/03/28 | Notification|CEP granted|28/03/2023; Minor revision|Accepted - CEP remains valid|29/11/2022; Notification|CEP granted|08/09/2021 |
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