| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 931 | Metformin Hydrochloride | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2004-088 - Rev 10 | 2025/09/18 | Valid | Chemical | 2025/09/18 | Minor revision|CEP granted|18/09/2025; Minor revision|CEP granted|21/11/2024; Notification|CEP granted|13/12/2023; Minor revision|CEP granted|02/03/2021 |
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| 2018 | Paroxetine hydrochloride hemihydrate | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2006-206 - Rev 05 | 2025/09/18 | Valid | Chemical | 2025/09/18 | Minor revision|CEP granted|18/09/2025; Minor revision|Accepted - CEP remains valid|15/10/2024; Notification|CEP granted|13/12/2023; Minor revision|CEP granted|26/01/2023; Minor revision|Accepted - CEP remains valid|13/07/2022; Notification|Accepted - CEP remains valid|06/11/2020 |
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| 2617 | Aripiprazole | ZAKŁADY FARMACEUTYCZNE POLPHARMA S.A. Starogard Gdański PL | 100000470;100001572 | CEP 2013-230 - Rev 03 | 2025/09/18 | Valid | Chemical | 2025/09/18 | Minor revision|CEP granted|18/09/2025; Minor revision|CEP granted|17/03/2023; Monograph revision|CEP granted|16/07/2021; Renewal|CEP granted|11/06/2020 |
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| 334 | Hydrocortisone acetate, Micronised, Grades I and II | SYMBIOTEC PHARMALAB PRIVATE LIMITED Indore IN | 100018972;100095999 | CEP 2016-228 - Rev 03 | 2025/09/18 | Valid | Chemical | 2025/09/18 | Minor revision|CEP granted|18/09/2025; Renewal|CEP granted|27/10/2023; Minor revision|CEP granted|16/09/2022 |
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| 1287 | Alfuzosin hydrochloride | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2007-080 - Rev 04 | 2025/09/18 | Valid | Chemical | 2025/09/18 | Minor revision|CEP granted|18/09/2025; Minor revision|Accepted - CEP remains valid|29/08/2024; Notification|CEP granted|16/11/2023; Notification|Accepted - CEP remains valid|15/07/2021; Minor revision|Accepted - CEP remains valid|08/09/2020 |
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| 2409 | Diacerein | AMI LIFESCIENCES PRIVATE LIMITED Vadodara IN | 100021822;100030527 | CEP 2015-173 - Rev 04 | 2025/09/18 | Valid | Chemical | 2025/10/17 | Minor revision|Accepted - CEP remains valid|17/10/2025; Minor revision|CEP granted|18/09/2025; Minor revision|CEP granted|03/12/2024; Minor revision|Accepted - CEP remains valid|28/11/2022; Administrative procedure|CEP granted|04/04/2022; Notification|CEP granted|18/01/2022; Renewal|CEP granted|17/11/2021 |
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| 2751 | Valaciclovir hydrochloride hydrate | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2013-318 - Rev 03 | 2025/09/18 | Valid | Chemical | 2025/09/18 | Minor revision|CEP granted|18/09/2025; Notification|CEP granted|02/02/2024; Major revision|CEP granted|22/08/2022 |
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| 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 | 2025/09/17 | 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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