| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2631 | Rosuvastatin calcium | SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN | 100023303;100032437 | CEP 2019-309 - Rev 03 | 2025/09/18 | Valid | Chemical | 2025/09/18 | Renewal|CEP granted|18/09/2025; Minor revision|Accepted - CEP remains valid|14/03/2024; Notification|CEP granted|26/01/2024; Minor revision|CEP granted|26/10/2023; Minor revision|Accepted - CEP remains valid|03/10/2022 |
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| 2531 | Clopidogrel hydrogen sulfate, Form-II | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2018-220 - Rev 05 | 2025/09/18 | Valid | Chemical | 2025/09/18 | Notification|CEP granted|18/09/2025; Renewal|CEP granted|17/01/2025; Notification|CEP granted|22/07/2024; Notification|CEP granted|01/09/2021; Minor revision|CEP granted|15/07/2021 |
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| 1658 | Spectinomycin sulfate tetrahydrate for veterinary use | HEBEI SHENGXUE DACHENG PHARMACEUTICAL CO. LTD. Shijiazhuang City CN | 100016575;100025368 | CEP 2020-069 - Rev 02 | 2025/09/18 | Valid | Chemical | 2025/09/18 | Renewal|CEP granted|18/09/2025; Minor revision|CEP granted|06/05/2024; New application|CEP granted|27/01/2021 |
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| 2573 | Candesartan cilexetil, Process II | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2019-303 - Rev 04 | 2025/09/18 | Valid | Chemical | 2025/09/18 | Notification|CEP granted|18/09/2025; Renewal|CEP granted|13/05/2025; Notification|CEP granted|15/07/2024; Major revision|CEP granted|12/10/2022 |
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| 884 | Carbimazole | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2017-201 - Rev 02 | 2025/09/18 | Valid | Chemical | 2025/09/18 | Minor revision|CEP granted|18/09/2025; Notification|CEP granted|16/01/2024; Renewal|CEP granted|13/03/2023; Minor revision|CEP granted|15/06/2022; Notification|Accepted - CEP remains valid|12/08/2021; Minor revision|CEP granted|12/03/2020 |
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| 2932 | Rivaroxaban, Modification-I | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2021-259 - Rev 03 | 2025/09/18 | Valid | 27/01/2028 | Chemical | 2025/09/18 | Notification|CEP granted|18/09/2025; Notification|CEP granted|11/07/2024; Minor revision|CEP granted|18/12/2023; New application|CEP granted|27/01/2023 |
|
| 1065 | Alprazolam, Process II | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2024-504 - Rev 01 | 2025/09/18 | Valid | 28/03/2030 | Chemical | 2025/09/18 | Notification|CEP granted|18/09/2025; New application|CEP granted|28/03/2025 |
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| 2573 | Candesartan cilexetil, Process 2 | ZHUHAI RUNDU PHARMACEUTICAL CO., LTD. Zhuhai City CN | 100033558;100052545 | CEP 2023-096 - Rev 01 | 2025/09/18 | Valid | 19/05/2028 | Chemical | 2025/12/10 | Notification|Accepted - CEP remains valid|10/12/2025; Major revision|CEP granted|18/09/2025; New application|CEP granted|19/05/2023 |
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| 2334 | Letrozole | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2022-209 - Rev 02 | 2025/09/18 | Valid | 18/03/2029 | Chemical | 2025/09/18 | Minor revision|CEP granted|18/09/2025; Notification|CEP granted|10/03/2025; New application|CEP granted|18/03/2024 |
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| 1065 | Alprazolam, Form-III | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2024-586 - Rev 01 | 2025/09/18 | Valid | 01/04/2030 | Chemical | 2025/09/18 | Notification|CEP granted|18/09/2025; New application|CEP granted|01/04/2025 |
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| 2777 | Pregabalin, Process II, Milled, Form-I | INTAS PHARMACEUTICALS LIMITED Ahmedabad IN | 100011529;100023432 | CEP 2022-028 - Rev 02 | 2025/09/18 | Valid | 04/07/2028 | Chemical | 2025/09/18 | Minor revision|CEP granted|18/09/2025; Minor revision|CEP granted|23/09/2024; New application|CEP granted|04/07/2023 |
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| 2176 | Febantel for veterinary use | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2006-260 - Rev 06 | 2025/09/17 | Valid | Chemical | 2025/09/17 | Notification|CEP granted|17/09/2025; Notification|CEP granted|22/07/2024; Notification|CEP granted|01/09/2021 |
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| 2287 | Fluconazole | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2007-256 - Rev 06 | 2025/09/17 | Valid | Chemical | 2026/02/02 | Monograph revision|Accepted - CEP remains valid|02/02/2026; Notification|CEP granted|17/09/2025; Notification|CEP granted|11/07/2024; Minor revision|Accepted - CEP remains valid|10/08/2023 |
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| 2219 | Lansoprazole | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2008-240 - Rev 04 | 2025/09/17 | Valid | Chemical | 2025/09/17 | Notification|CEP granted|17/09/2025; Notification|CEP granted|12/07/2024 |
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| 1065 | Alprazolam | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2008-060 - Rev 03 | 2025/09/17 | Valid | Chemical | 2025/09/17 | Notification|CEP granted|17/09/2025; Major revision|Rejected|08/10/2024; Notification|CEP granted|12/07/2024 |
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| 968 | Aciclovir | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 1998-029 - Rev 11 | 2025/09/17 | Valid | Chemical | 2025/09/17 | Notification|CEP granted|17/09/2025; Notification|CEP granted|12/07/2024; Monograph revision|Accepted - CEP remains valid|24/06/2021; Minor revision|CEP granted|23/02/2021 |
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| 1335 | Itraconazole | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2005-269 - Rev 07 | 2025/09/17 | Valid | Chemical | 2025/09/17 | Notification|CEP granted|17/09/2025; Notification|CEP granted|12/07/2024; Minor revision|CEP granted|16/09/2022 |
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| 2589 | Abacavir sulfate | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2013-141 - Rev 02 | 2025/09/17 | Valid | Chemical | 2025/09/17 | Notification|CEP granted|17/09/2025; Notification|CEP granted|19/07/2024; Minor revision|Accepted - CEP remains valid|12/04/2022; Minor revision|Accepted - CEP remains valid|09/12/2020 |
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| 2244 | Tacrolimus monohydrate | FISHFA BIOGENICS Rajkot IN | 100044306;100073256 | CEP 2023-394 - Rev 00 | 2025/09/17 | Valid | 17/09/2030 | Chemical | 2025/09/17 | New application|CEP granted|17/09/2025 | |
| 2154 | Telmisartan | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2008-256 - Rev 04 | 2025/09/17 | Valid | Chemical | 2025/09/17 | Notification|CEP granted|17/09/2025; Notification|CEP granted|11/07/2024; Minor revision|CEP granted|04/10/2023 |
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